Frey's Pancreaticojejunostomy in Tropical Pancreatitis

Frey’s Pancreaticojejunostomy in Tropical Pancreatitis: Assessment of Quality of Life. A Prospective Study Vamsi Krishna Pothula Rajendra, Sivaraj Sivanpillay Mahadevan, Sivacharan Reddy Parvathareddy, Bharat Kumar Nara, et al. World Journal of Surgery Official Journal of the International Society of Surgery/Société Internationale de Chirurgie ISSN 0364-2313 World J Surg DOI 10.1007/s00268-014-2732-7

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Author's personal copy World J Surg DOI 10.1007/s00268-014-2732-7

SURGICAL SYMPOSIUM CONTRIBUTION

Frey’s Pancreaticojejunostomy in Tropical Pancreatitis: Assessment of Quality of Life. A Prospective Study Vamsi Krishna Pothula Rajendra • Sivaraj Sivanpillay Mahadevan Sivacharan Reddy Parvathareddy • Bharat Kumar Nara • Mallikarjuna Gorlagunta Ramachandra • Aditya Chowdary Tripuraneni Venkata • Jagan Mohan Reddy Bathalapalli • Vara Prasada Rao Gudi • Thirunavukkarasu Sampath

•

Socie´te´ Internationale de Chirurgie 2014

Abstract Introduction Tropical pancreatitis is a form of chronic pancreatitis originally described in the tropics. Prospective studies in Western countries have shown improved quality of life (QOL) following surgery in alcoholic chronic pancreatitis. In studies on Frey’s pancreaticojejunostomy for tropical pancreatitis, improvement in pain was considered the endpoint, and there is a paucity of data in the literature with regard to QOL with tropical pancreatitis following surgery. Objective Our objective was to prospectively analyze the outcome of Frey’s pancreaticojejunostomy in tropical pancreatitis and health-related QOL following surgery by administering the Short Form 36-item health survey (SF36). Materials and methods A total of 25 patients underwent Frey’s pancreaticojejunostomy between 2010 and 2012 and were included in the study; data were collected prospectively. The visual analog scale (VAS) for pain and the SF-36 form were used to record health-related QOL preoperatively, and at 3 and 12 months post-surgery, comparing the same with the general population. Results Patients with tropical pancreatitis experience poor QOL (26.71 ± 15.95) compared with the general population (84.54 ± 12.42). Post-operative QOL scores (78.54 ± 15.84) were better than the pre-operative scores (26.71 ± 15.95) at 12-month post-surgery follow-up. The VAS score for pain improved at 12 months post-surgery (1.58 ± 1.41 vs. 8.21 ± 1.64). Two of the three patients (12.5 %) who had diabetes were free from anti-diabetes medication at 12 months post-surgery. Steatorrhea was seen in five patients (20.8 %) before surgery and increased to eight (33.3 %) at 12 months post-surgery. Mean body weight increased from 45.75 kg pre-operatively to 49.25 kg at 12 months post-operatively. Conclusions Frey’s pancreaticojejunostomy effectively reduces pain in tropical pancreatitis, with significant improvement in health-related QOL, which is comparable with the general population in most aspects.

Introduction V. K. Pothula Rajendra (&) S. Sivanpillay Mahadevan S. R. Parvathareddy B. K. Nara M. Gorlagunta Ramachandra A. C. Tripuraneni Venkata J. M. R. Bathalapalli V. P. R. Gudi T. Sampath Department of Surgical Gastroenterology, Narayana Medical College, Nellore, Andhra Pradesh, India e-mail: [email protected]

Chronic pancreatitis is a chronic benign disease characterized by recurrent episodes of abdominal pain accompanied by progressive pancreatic exocrine and endocrine insufficiency. Tropical calcific pancreatitis is a form of

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Author's personal copy World J Surg Fig. 1 Study design Total chronic pancreatitis patients (362)

Patients managed medically

Surgically managed (31)

(331)

Other procedures

Frey's procedure

whipples ( 3)

(25)

Patients included in the study

Patients lost follow up excluded

(24 )

(1)

idiopathic chronic pancreatitis with distinct clinical and epidemiological characteristics: abdominal pain, large pancreatic calculi, diabetes mellitus, and a high rate of pancreatic cancer occurring in non-alcoholics, usually children or young adults [1, 2]. Several reports of tropical calcific pancreatitis have been reported from tropical parts of Asia, Africa, and South America. Surgery has been the mainstay of treatment in these patients with intractable pain unresponsive to medical or endoscopic therapy [3]. Frey’s pancreaticojejunostomy has been associated with good post-operative pain control with low mortality and morbidity. The pain relief following surgery in tropical pancreatitis has been variably quoted as 36.5 % [4] to 81 % [5]. Poor results in some studies [4] may be mainly due to improper selection of cases and incomplete drainage, leading to less uniform results. Since chronic pancreatitis is a benign non-curable disease with a protracted natural course, pain relief as the successful outcome of the disease reflects only one aspect of the multidimensional outcome of surgical intervention. Hence, when analyzing the outcomes of therapeutic interventions, it is better to use health-related quality of life (HR-QOL) to ascertain the efficacy of the intervention and impact on the disease. HRQOL is becoming an important tool for assessing the outcome of interventions and validating them when various modalities are available for the management of chronic diseases, in view of a rising demand for healthcare and increasing healthcare costs. Even though there are many studies describing the outcome of surgery in tropical

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distal pancreatectomy (3)

calcific pancreatitis [4–7], there are no prospective studies, and most studies did not use standardized validated tools to assess HR-QOL following surgery. The high level of evidence in the determination of HRQOL is the multidimensional approach covering domains of physical, psychological, social, and functional wellbeing. The Short-Form 36-item health survey (SF-36) is one such tool that is well validated in assessing HR-QOL in chronic pancreatitis. Hence, the objective of our study is to prospectively analyze the outcome of Frey’s pancreaticojejunostomy in tropical pancreatitis in terms of HR-QOL following surgery by administering the SF-36.

Materials and methods This is a prospective study conducted in the Department of Surgical Gastroenterology, Narayana Medical College, Nellore, India, from September 2010 to December 2012. The study population comprised patients visiting the Department of Surgical Gastroenterology, Narayana Medical College and Hospital. Study design is depicted in Fig. 1. Definitions Chronic pancreatitis is defined by features consistent with irreversible pancreatic inflammation, i.e., clinical,

Author's personal copy World J Surg

structural, or functional abnormality of the pancreas [8]. Patients with classical pancreatic-type pain radiating to the back, with imaging showing parenchymal and ductal abnormalities and calcification were included in the study. There is no formal widely accepted definition of tropical pancreatitis. However, based on various reports of tropical pancreatitis, the disease might best be characterized as a definite type of idiopathic chronic pancreatitis occurring in tropical countries that usually affects young, often malnourished, individuals and that leads to abdominal pain, pancreatic calculi, and ketosis-resistant diabetes [9]. In this study, we defined tropical pancreatitis based on its most distinctive features: typical pancreatic-type pain with onset at less than 30 years of age, imaging showing large irregular coarse calculi in the main pancreatic duct [10–12], subjects who were not chronic alcoholics (chronic alcoholism is defined as an intake of ethanol 80 g/day for at least 5 years [4, 13, 14]), and, lastly, who did not have any other specific cause for the pancreatitis. Alcoholic chronic pancreatitis is defined as features of chronic pancreatitis in chronic alcoholics, and imaging showing small speckled calcification of the pancreas. Diabetes mellitus is defined as fasting plasma glucose values C126 mg/dL and/or a post-prandial plasma glucose value C200 mg/dL, confirmed on two occasions, and/or a requirement for insulin or oral hypoglycemic drugs. Steatorrhea is defined by the passage of large, bulky, greasy, semisolid or liquid stools. Patients were investigated with transabdominal ultrasound and then with contrast-enhanced computerized tomography (CECT). Other investigations (magnetic resonance cholangiopancreatography [MRCP] and endoscopic retrograde cholangiopancreatography [ERCP]) were used when appropriate. Presence of inflammatory head mass is defined as head mass measuring [3.5 cm [15] on CECT in a patient with chronic pancreatitis. Indication for surgery Alcoholic patients were advised to undergo surgery only when they were willing to abstain from alcohol after surgery. Patients underwent surgery for chronic pancreatitis if they had any one of the following features: intractable pain not relieved by medication (the most common indication); intractable pain requiring high and toxic doses of analgesics for control of pain; and recurrent episodes of pain with acute exacerbation of chronic pancreatitis affecting daily activities, requiring repeated hospital admissions. Inclusion and exclusion criteria All patients with the above-mentioned indications who underwent Frey’s pancreaticojejunostomy were included in

the study. Chronic pancreatitis patients who underwent procedures other than Frey’s pancreaticojejunostomy and patients not willing to have regular follow-up or not willing to respond to the SF-36 after surgery were excluded from the study. A total of 31 controls were selected randomly from the general population and matched for age, sex, and socioeconomic status. SF-36 and visual analog scale (VAS) HR-QOL scores of participants were calculated with the SF-36, which is well known for its comprehensiveness, brevity, and high standards of reliability and validity [16– 24]. We chose the SF-36 questionnaire over other generic HR-QOL measures because it has demonstrated excellent reliability and validity when employed with diverse medical conditions, including chronic pancreatitis [25–30]. The SF-36 provides an estimate of perceived health status and well-being, and is based on 36 multiple-choice questions, measuring eight different domains: four in the area of physical health (physical functioning [PF], role limitation physical [RP], bodily pain [BP], and general health [GH]) and four in the area of mental health (role limitationemotional [RE], vitality [VT], mental health [MH], and social functioning [SF]). The two comprehensive indices physical health (PH) and mental health (MH) were evaluated using the eight domains of the questionnaire. Finally, the total SF-36 score is calculated for all patients using the above domains. The visual analog scale (VAS) was used to subjectively evaluate the capacity of the individual to cope with pain. The VAS is known for its great sensitivity for reliable measurement of subjective phenomena of various qualities of pain [31]. The VAS score was divided as follows: -0 to 4 mm indicates no pain; 5–44 mm indicates mild pain; 45–74 mm indicates moderate pain; and 75–100 mm indicates severe pain [32]. The percentage of patients falling into each category was calculated. The absolute change and percentage of change in the pain scores were also calculated. Methods of study The SF-36 questionnaire was administered in Telugu (the local Indian language) and in British English. The questionnaire and how to mark responses were explained in detail to cases and controls. The SF-36 and VAS scores were acquired pre-operatively in the hospital during admission, and at 3-month and 1-year post-surgery followup, also in the hospital. The results are expressed as mean ± standard deviation (SD). Statistical significance was estimated using the Wilcoxon rank test, Mann–Whitney U test, and Fisher’s exact test, as appropriate. The level

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of significance was set to p \ 0.05. The statistics in this study were analyzed with the help of SPSS version 17 (IBM Inc., Armonk, NY, USA).

Table 1 Demographics and pre-operative disease characteristics Demographics and pre-operative disease characteristics

Cases (n = 24)

Tropical pancreatitis (n = 16) (66.7 %)

ACP (n = 8) (33.3 %)

Ethics

Age

27.04 (±9.63)

23.56 (±7.75)

34.00 (9.65)

16 (66)

8 (50)

8 (33)

8 (50)

24 (100)

16 (66.7)

45.75 (±9.96)

46.06 (±11.22)

Sex

Approval for the study was obtained from the Human Research Ethics Committee (Medical) of the NTR University of Health Sciences Vijayawada, protocol number M050425. All participants provided written informed consent. The study protocol conforms to the ethical guidelines of the World Medical Association (WMA) Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the 59th WMA General Assembly, Seoul, South Korea, October 2008. Surgical procedure

Males Females Socioeconomic status Body weight

0 (0) 8 (33.3) 45.13 (±7.43)

Alcoholism

9 (37.5)

1 (6.3)

8 (100)

Smoking

5 (20.8)

1 (6.3)

4 (50)

Diabetes

3 (12.5)

1 (6.3)

2 (25)

Steatorrhea CBD diameter (6–20 mm)

5 (20.8) 7.71 (±3.45)

2 (12) 7.75 (±3.71)

3 (37) 7.63 (±3.11)

MPD diameter (4–17 mm)

8.29 (±3.18)

8.69 (±3.68)

7.50 (±1.77)

8 (33.3)

3 (18.8)

5 (62.5)

Head mass

With a bilateral subcostal or midline incision, the pancreas is exposed by mobilization of hepatic flexure, kocherization, and opening the gastrocolic omentum. The pancreatic duct is identified and opened along the entire course, and all stones and protein plugs removed. Care is taken to remove all the stones present in the main pancreatic duct, uncinate duct, and side branches. Extensive coring of the head of the pancreas and removal of all stones located in the main pancreatic duct and the side branch ducts were the important surgical principles followed during the surgery.

8 (100)

Data are presented as mean (±standard deviation) or n (%), unless otherwise indicated ACP alcoholic chronic pancreatitis, CBD common bile duct, MPD main pancreatic duct

7.71 mm (range 6–20). Eight patients with chronic pancreatitis presented with head mass, of which three (18.8 %) patients had tropical pancreatitis and five (62.5 %) had alcoholic pancreatitis. No head mass was diagnosed as malignant following histopathological examination.

Results

Operative parameters and post-operative complications

Demographics and pre-operative disease characteristics

The primary indication for surgery was intractable pain in all the patients (Table 2). All patients underwent Frey’s pancreaticojejunostomy. Three patients also underwent hepatico-jejunostomy, in view of a dilated bile duct. Mean operative time was 240 min, with a mean blood loss of 338 ml. Post-operatively, two patients had minimal wound infection, which was treated with drainage and antibiotics. One patient had bleeding from post-operative stress gastritis, managed with proton pump inhibitors and sucralfate. One patient developed pneumonitis, which required mechanical ventilation for 3 days. No patient developed pancreatic leak, as measured by post-operative drain amylase levels.

Between 2010 and 2012, a total of 25 patients underwent Frey’s pancreaticojejunostomy (Table 1). One patient was lost to follow-up and excluded from the study. There were 16 males and eight females, with a ratio of 2:1. A total of 16 (67 %) patients presented with tropical pancreatitis, one patient in the tropical pancreatitis group was an alcoholic, but that patient showed large intraductal calculi on imaging, had an early age of onset, and had a short duration of alcohol intake. Eight (33 %) patients presented with alcoholic chronic pancreatitis and five patients were chronic smokers. Pre-operatively, three patients were diabetic and five patients had steatorrhea. On imaging, the mean main pancreatic duct (MPD) was 8.29 mm (range 4–17). There was no difference in duct size between the alcoholic and tropical pancreatitis patients. The mean bile duct diameter was

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Pain scores The pain from chronic pancreatitis in all the patients reduced significantly at 3 months as represented by improved VAS scores (p \ 0.0001) and bodily pain

Author's personal copy World J Surg Table 2 Operative parameters and post-operative complications

Operative and post-operative parameters

Cases (n = 24)

Tropical pancreatitis (n = 16)

ACP (n = 8)

Indication for surgery Pain

23 (95.9)

15 (93.8)

1 (4.2)

1 (6.3)

21 (87.5)

13 (81.3)

3 (12.5)

3 (18.8)

337.50 (±140.07)

325 (±75.27)

Pain ? obstructive jaundice

8 (100) 0 (0)

Surgery Frey’s Frey’s ? HJ Blood loss (200–900 ml) Operative time (min) Data are presented as mean (±standard deviation) or n (%), unless otherwise indicated ACP alcoholic chronic pancreatitis, HJ hepaticojejunostomy

240 (±46.62)

8 (100) 0 (0) 362 (±226.38)

226.88 (±26.76)

266.25 (±66.53)

Wound infection

2 (8.3)

1 (50)

1 (50)

Pancreatic leak

0 (0)

0 (0)

0 (0)

Bleeding Pulmonary complications

1 (4.1) 1 (4.1)

1 (4.1) 1 (4.1)

0 (0) 0 (0)

Enteric leak

0 (0)

0 (0)

0 (0)

domain QOL scores in the SF-36. This was sustained at 12 months, with a marginal improvement when compared with 3 months (Table 3; Fig. 2). When measured by VAS pre-operatively, 18 (75 %) patients were in severe pain and six (25.0 %) were in moderate pain. At 12 months postsurgery, no patient (0 %) was in severe pain, two (8.3 %) were in moderate pain, 18 (75 %) were in mild pain, and four (16.7 %) were in absolutely no pain (Table 4). Absolute change in pain scores was calculated as 66.25 (±20.60) and mean percentage of change in pain scores was analyzed as 79.98 (±17.64).

At 3 months post-operatively, the SF-36 QOL score improved when compared with pre-operative scores (69.29 ± 20.87 vs. 26.71 ± 15.95) but lower than those of the control group (84.54 ± 12.42), which was statistically significant (p \ 0.001) (Table 7).

9 PREOPERATIVE

8

3 MONTHS POST SURGERY 12 MONTHS POST SURGERY

7 6

Quality of life

5

Before undergoing surgery, patients with chronic pancreatitis had poor QOL (range 6–66) when compared with healthy matched controls (total SF-36 mean [±SD] 26.71 [±15.95] vs. 84.54 [±12.42]), which was statistically significant (p \ 0.0001). All the eight domains of the SF-36 were significantly affected (p \ 0.0001) in patients with chronic pancreatitis (Table 5). In both etiological types, the SF-36-calculated pre-operative QOL was significantly poorer than that of controls, and it was worst in alcoholic pancreatitis when compared with tropical pancreatitis (14.00 [±5.47] vs. 33.06 [±15.72]) (Table 6).

4 3 2 1 0 VAS

Fig. 2 Visual analog score (VAS)

Table 3 Pain scores: pre-operative, 3 months post-surgery, and 12 months post-surgery Pain scores VAS Bodily pain domain

Pre-operative

3 months

p value

12 months

p value

p value 3 vs. 12 months

8.21 (±1.64)

1.71 (1.12)

0.0001

1.58 (1.41)

0.0001

0.33

19.96 (±19.24)

72.12 (24.97)

0.0001

76.96 (18.95)

0.0001

0.308

Data are presented as mean (±standard deviation) unless otherwise indicated VAS visual analog scale

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Author's personal copy World J Surg Table 4 Pain scores: VAS classification VAS classification

Pre-operative

No pain

0 (0)

Mild pain

0 (0)

Moderate pain

6 (25)

Severe pain

18 (75)

12 months post-surgery 4 (16.7) 18 (75) 2 (8.3) 0 (0)

Data are presented as n (%) Absolute change in VAS 66.25 (±20.602); mean percentage of change in VAS 79.98 (±17.64) VAS visual analog scale

Table 5 Health-related quality of life: cases (pre-operative) and controls SF-36 domains

Controls (n = 31)

Cases (n = 24)

p value*

Physical function (PF)

91.29 (±14.31)

50.21 (±23.47)

0.0001

Role physical (RP)

88.70 (±18.07)

15.63 (±31.11)

0.0001

Bodily pain (BP)

83.70 (±21.59)

19.96 (±19.24)

0.0001

General health (GH)

77.80 (±18.63)

19.13 (±23.19)

0.0001

Vitality (V)

75.48 (±20.58)

23.33 (±14.79)

0.0001

Social function (SF)

82.41 (±22.23)

39.83 (±24.88)

0.0001

Role of emotion (RE)

84.96 (±27.02)

15.25 (±31.05)

0.0001

Mental health (MH)

81.41 (±15.88)

30.83 (±21.57)

0.0001

Physical health

84.16 (±12.09)

25.54 (±15.54)

0.0001

Mental health

82.12 (±13.31)

25.69 (±15.89)

0.0001

Total SF-36 score

84.54 (±12.42)

26.71 (±15.95)

0.0001

Data are presented as mean (±standard deviation) unless otherwise indicated Significant difference in QOL in all domains of SF-36 comparing chronic pancreatitis patients to the general population QOL quality of life, SF-36 short-form 36-item health survey p value significant at \0.05 * Wilcoxon signed rank test

At 12 months post-operatively, the QOL of cases had improved (total SF-36 78.54 ± 15.84) but were significantly lower than those of the healthy matched general population, p = 0.030 (Table 8). The physical function (PH), role physical (RP), general health (GH), mental health (MH), and role emotion (RE) domains were comparable to those of the general population; however, the bodily pain (BP) and social function (SF) domains were significantly lower, and the vitality domain was marginally lower (Table 8). Improvement of QOL in patients with chronic pancreatitis was statistically significant (p \ 0.0001) (pre-operative QOL 26.71 ± 15.95; 3-month QOL 69.29 ± 20.87; 12-month QOL 78.54 ± 15.84) (Table 9; Fig. 3).

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Total SF-36 scores in patients with mild pain ranged from 30 to 99 (mean [±SD] 77.00 [±17.31]) and in patients with moderate pain ranged from 70 to 78 (74.00 [±5.65]). Although two patients in the study had moderate pain at 12 months after surgery, their QOL values improved to 70 and 78, from pre-operative QOL of 15 and 8, respectively. Of the 18 patients who had mild pain, most of the patients had good QOL; only two patients had scores \50. The rest of the patients had QOL scores of C68. Outcomes based on etiology at 3 and 12 months postsurgery are shown in Tables 10 and 11. On comparing tropical pancreatitis (range 8–66) and alcoholic pancreatitis (range 6–25), the pre-operative QOL predicted by total SF36 scores were significantly lower with alcoholic pancreatitis (14.00 vs. 33.06) (Table 12), which was statistically significant (p \ 0.001). Post-operatively, even though the total SF-36 scores were lower with alcoholic pancreatitis than with tropical pancreatitis at 3 and 12 months, they were not statistically significant (p = 0.878 and 0.141, respectively) (Table 12). The body weight of patients improved significantly following surgery (p = 0.004). Eight of the nine patients who were alcoholic abstained from alcohol (p = 0.004). Pre-operatively, three patients required insulin or oral hypoglycemic agents for blood sugar control, but, postoperatively, only one patient required medication for glycemic control; however, this was not found to be statistically significant. Pre-operatively, five patients presented with steatorrhea; post-operatively, eight patients had steatorrhea, which was not statistically significant (Fig. 4). On analyzing the QOL scores on the basis of physical health score, females had better scores than males at 12 months post-operatively, with a significant p value (p = 0.014), but the total SF-36 score was not significantly different. On the same analysis in patients with tropical pancreatitis, the QOL score was not significantly different (p = 0.206). Post-operatively, VAS scores were not significantly different between the sexes. Eight patients presented with a head mass of more than 3.5 cm. On analyzing the QOL and VAS in patients with and without head mass, there was no significant difference (p = 0.256).

Discussion Idiopathic chronic pancreatitis in developing countries in the tropics was termed ‘tropical pancreatitis’ by Zuidema et al. [33] in 1955. It is seen in non-alcoholics, presenting at a young age, with predominantly large MPD calculi. The mean age of presentation is in the second decade, which was a decade earlier than patients considered to have an alcoholic etiology and was similar to findings in other studies on tropical pancreatitis [2]. Both sexes were

Author's personal copy World J Surg Table 6 Quality of life: health-related quality of life outcomes based on etiology (pre-operative) SF-36 domains

Controls (n = 31)

Cases pre-operative (n = 24) Tropical pancreatitis (n = 16)

p value*

ACP (n = 8)

p value*


91.29 (±14.31)

56.88 (±21.36)

0.001

36.88 (±22.98)

0.012

Role physical (RP)

88.70 (±18.07)

23.44 (±35.90)

0.001

00.00 (±.000)

0.007

Bodily pain (BP)

83.70 (±21.59)

27.31 (±19.07)

0.001

5.25 (±8.137)

0.011

General health (GH)

77.80 (±18.63)

24.00 (±25.57)

0.001

9.38 (±14.252)

0.012

Vitality (V)

75.48 (±20.58)

26.88 (±15.37)

0.0001

16.25 (±11.260)

0.012


82.41 (±22.23)

47.94 (±24.15)

0.002

23.63 (±18.291)

0.011

Role of emotion (RE) Mental health (MH)

84.96 (±27.02) 81.41 (±15.88)

22.88 (±35.94) 36.00 (±22.90)

0.002 0.0001

00.00 (±.000) 20.50 (±14.880)

0.005 0.012

Physical health

84.16 (±12.09)

31.56 (±15.72)

0.0001

13.50 (±3.92)

0.012

Mental health

82.12 (±13.31)

31.56 (±15.90)

0.0001

13.88 (±7.06)

0.012

Total SF-36 score

84.54 (±12.42)

33.06 (±15.72)

0.0001

14.00 (±5.47)

0.012

Data are presented as mean (±standard deviation) unless otherwise indicated ACP alcoholic chronic pancreatitis, SF-36 short-form 36-item health survey p value significant at \0.05 * Wilcoxon signed rank test

Table 7 Health-related quality of life at 3 months post-surgery: cases and controls Domains of SF-36 health survey

Controls (n = 31)

3 months postsurgery

p value*


91.29 (±14.31)

32.42 (±24.40)

0.0001

Table 8 Health-related quality of life at 12 months post-surgery: cases and controls SF-36 domains

Controls (n = 31)


p value*


91.29 (±14.31)

93.54 (±14.98)

0.396#

Role physical (RP)

88.70 (±18.07)

81.25 (±34.77)

0.346#

Bodily pain (BP)

83.70 (±21.59)

76.96 (±18.95)

0.019

General health (GH) Vitality (V)

77.80 (±18.63)

71.25 (±25.87)

0.254#

75.48 (±20.58)

70.00 (±18.59)

0.055


82.41 (±22.23)

79.92 (±15.53)

0.038


84.96 (±27.02)

82.00 (±31.03)

0.720#

Data are presented as mean (±standard deviation) unless otherwise indicated

Mental health (MH)

81.41 (±15.88)

80.83 (±30.85)

0.639#

SF-36 short-form 36-item health survey

Physical health

84.16 (±12.09)

78.17 (±17.06)

0.044

p value significant at \0.05

Mental health

82.12 (±13.31)

75.17 (±15.75)

0.029

* Wilcoxon signed rank test

Total SF-36 score

84.54 (±12.42)

78.54 (±15.84)

0.030

Role physical (RP)

88.70 (±18.07)

65.63 (±37.45)

0.027

Bodily pain (BP)

83.70 (±21.59)

72.13 (±24.97)

0.006

General health (GH)

77.80 (±18.63)

61.88 (±27.08)

0.021

Vitality (V)

75.48 (±20.58)

61.04 (±21.31)

0.003


82.41 (±22.23)

77.79 (±15.65)

0.016


84.96 (±27.02)

63.92 (±42.77)

0.075

Mental health (MH)

81.41 (±15.88)

67.33 (±17.87)

0.003

Physical health

84.16 (±12.09)

68.92 (±21.22) \0.001

Mental health

82.12 (±13.31)

66.63 (±20.60) \0.002

Total SF-36 score

84.54 (±12.42)

69.29 (±20.87) \0.002

affected equally. There was no difference in socioeconomic status and body weight, a finding highlighted in other recent studies [2], whereas, in older studies, tropical pancreatitis patients were malnourished [34]. The MPD diameter was larger in tropical pancreatitis but not significant, probably due to a smaller sample size. Pancreatic calculi were predominantly found in the main duct in non-

Data are presented as mean (±standard deviation) unless otherwise indicated p value significant at \0.05 SF-36 short-form 36-item health survey * Wilcoxon signed rank test Physical function (PF), role physical (RP), general health (GH), role of emotion (RE), mental health (MH) domains are comparable to those of the general population #

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Author's personal copy World J Surg Table 9 Health-related quality of life and visual analog scores: cases (pre-operative, 3 months, 12 months post-surgery) SF-36 domains

Pre-operative (n = 24)


p value*


p value*

3 vs. 12 months p value*


50.21 (±23.47)

32.42 (±24.40)

0.007

93.54 (±14.98)

0.0001

0.001

Role physical (RP)

15.63 (±31.11)

65.63 (±37.45)

0.0001

81.25 (±34.77)

0.0001

0.028

Bodily pain (BP)

19.96 (±19.24)

72.13 (±24.97)

0.0001

76.96 (±18.95)

0.0001

0.308

General health (GH)

19.13 (±23.19)

61.88 (±27.08)

0.0001

71.25 (±25.87)

0.0001

0.045

Vitality (V)

23.33 (±14.79)

61.04 (±21.31)

0.0001

70.00 (±18.59)

0.0001

0.058


39.83 (±24.88)

77.79 (±15.65)

0.0001

79.92 (±15.53)

0.0001

0.394


15.25 (±31.05) 30.83 (±21.57)

63.92 (±42.77) 67.33 (±17.87)

0.001 0.0001

82.00 (±31.03) 80.83 (±30.85)

0.0001 0.0001

0.038 0.039

Physical health

25.54 (±15.54)

68.92 (±21.22)

0.0001

78.17 (±17.06)

0.0001

0.012

Mental health

25.67 (±15.89)

66.63 (±20.60)

0.0001

75.17 (±15.75)

0.0001

0.007

Total SF-36 score

26.71 (±15.95)

69.29 (±20.87)

0.0001

78.54 (±15.84)

0.0001

0.008

8.21 (±1.64)

1.71 (±1.12)

0.0001

1.58 (±1.41)

0.0001

0.330

VAS

Data are presented as mean (±standard deviation) unless otherwise indicated Significant improvements in SF-36 domains and VAS scores comparing pre-operative with 12 months post-surgery SF-36 short-form 36-item health survey, VAS visual analog score p value significant at \0.05 * Wilcoxon signed rank test

80 70 60

pre operative 3 months post surgery

50

12 months post surgery

40 30 20 10

12 months post surgery 3 months post surgery pre operative

0 physical mental heaith health

total sf36 score

Fig. 3 Quality of life outcomes: cases (pre-operative, 3 months, 12 months post-surgery)

alcoholic patients, in contrast to smaller ductal calculi in alcoholics, similar to findings in other studies [9]. The mean age of patients undergoing surgery in this study is 27 years; the mean age for surgery for tropical pancreatitis is 23 years. This is less than in another study from south India, where the mean age of surgery was the fourth decade [5]. The difference may be because of a higher number of alcoholic pancreatitis included in that study. Tropical pancreatitis patients presented a decade earlier than those with alcoholic pancreatitis in the tropics.

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In the Western population, the mean age of surgery was two decades later than in tropical calcific pancreatitis and even with alcoholic pancreatitis, it is a decade later [15, 41, 45]. Pain was the major indication for surgery in all patients. On analyzing the pre-operative, early post-operative (3 months), and late post-operative (1 year) VAS scores, there is dramatic improvement in pain scores at 3 months (VAS 8.21 vs. 1.71), which was also sustained at 1 year (VAS 1.71 vs. 1.58). Most patients discontinued analgesics. At 1 year post-surgery, the mean percentage of change in VAS was 79.98 %, which is above the reasonable standard (33 %) for meaningful change in patient perspective [28]. Historically, surgical outcomes have been measured in clinical and objective terms like morbidity, mortality, and improvement in symptoms (pain scores). In chronic noncurable diseases like chronic pancreatitis, where no single intervention has proven to be useful in relieving the debilitating symptoms, the term HR-QOL has emerged to better describe the clinical benefits of interventions, and includes the multiple aspects of QOL that are most influenced by healthcare interventions [35]. QOL is multidimensional and encompasses physical symptoms, functional ability, emotional wellbeing, and social aspects [36]. When comparing treatment options, along with morbidity and mortality statistics, QOL provides comprehensive information about the functional limitations of procedural side effects. QOL results may help treatment decisions. Knowledge and communication of QOL results will lead to

Author's personal copy World J Surg Table 10 Health-related quality of life outcomes based on etiology at 3 months post-surgery SF-36 domains

Controls (n = 31)

Cases 3 months post-surgery Tropical pancreatitis (n = 16)

p value

ACP (n = 8)

p value


91.29 (±14.31)

38.38 (±26.38)

0.0001

20.50 (±14.88)

0.012

Role physical (RP)

88.70 (±18.07)

70.31 (±38.96)

0.202

56.25 (±34.71)

0.039

Bodily pain (BP)

83.70 (±21.59)

71.38 (±25.08)

0.067

73.63 (±26.42)

0.249

General health (GH)

77.80 (±18.63)

64.13 (±25.82)

0.074

57.38 (±30.77)

0.123

Vitality (V)

75.48 (±20.58)

57.19 (±21.75)

0.012

68.75 (±19.41)

0.886


82.41 (±22.23)

76.75 (±15.08)

0.022

79.88 (±17.59)

0.325


84.96 (±27.02) 81.41 (±15.88)

62.56 (±41.96) 68.00 (±15.38)

0.120 0.012

66.63 (±47.17) 66.00 (±23.22)

0.102 0.394

Physical health

84.16 (±12.09)

69.75 (±22.24)

0.062

67.25 (±20.38)

0.021

Mental health

82.12 (±13.31)

66.13 (±19.87)

0.023

67.63 (±23.38)

0.107

Total SF-36 score

84.54 (±12.42)

69.50 (±21.15)

0.046

68.88 (±21.72)

0.035


Table 11 Health-related quality of life outcomes based on etiology at 12 months post-surgery SF-36 domains

Controls (n = 31)

Cases pre-operative 12 months after surgery Tropical pancreatitis (n = 16)

p value*

ACP (n = 8)

p value*


81.41 (±15.88)

96.25 (±10.083)

0.778

88.13 (±21.702)

0.168

Role physical (RP)

88.70 (±18.07)

92.19 (±26.955)

0.427

59.38 (±39.950)

0.066

Bodily pain (BP)

83.70 (±21.59)

81.00 (±14.949)

0.194

68.88 (±24.281)

0.128

General health (GH)

77.80 (±18.63)

74.50 (±25.859)

0.816

64.75 (±26.337)

0.262

Vitality (V)

75.48 (±20.58)

71.5 (±17.654)

0.396

67.50 (±21.381)

0.888


82.41 (±22.23)

79.19 (±15.579)

0.140

81.38 (±16.422)

0.324


84.41 (±27.02) 81.41 (±15.88)

85.50 (±27.070) 83.75 (±26.975)

0.829 0.421

75.00 (±38.873) 75.00 (±38.873)

0.109 0.866

Physical health

84.16 (±12.09)

82.50 (±15.24)

0.856

69.50 (±18.18)

0.017

Mental health

82.12 (±13.31)

76.94 (±13.32)

0.255

71.63 (±20.32)

0.106

Total SF-36 score

84.54 (±12.42)

81.81 (±13.36)

0.478

72.00 (±19.20)

0.030


better informed patients, shared decision making, and improved outcomes [37]. Pre-operative QOL was significantly lower in patients with chronic pancreatitis than in the general population (26.7 vs. 84.54) in the current study. Previous studies focusing on surgical management by Frey’s pancreaticojejunostomy also had found similarly significantly lower pre-operative QOL [15]. Even though all the HR-QOL domains were significantly lower than those of the controls, role physical, role of emotion, general health perception,

and bodily pain were predominantly affected, while physical function was the least affected. This is similar in some other studies using the SF-36. In a German study by Wehler et al. [38], role physical, bodily pain, general health, and vitality were most affected in patients with chronic pancreatitis. In an Italian study by Pezzilli et al. [39], in chronic pancreatitis patients with pain, role physical was the most affected, along with the bodily pain and general health domains. In studies using the European Organisation for Research and Treatment of Cancer

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Author's personal copy 60

0.948

0.141

0.39

0.04

p value*

World J Surg

preoperative

p -0.004

50


1.75 (±1.90)

p 1.0

20 10 0 Body weight (kg) Alcoholism (%) Smoking (%)

diabetes (%) Steatorrhea (%)

* Mann–Whitney U test

Fig. 4 Etiological and disease characteristics: response to surgery

p value significant at \0.05

ACP alcoholic chronic pancreatitis, HR-QOL health-related quality of life, SF-36 short-form 36-item health survey, TP tropical pancreatitis, VAS visual analog scale

Data are presented as mean (±standard deviation) unless otherwise indicated

Poor pre-operative HR-QOL scores in ACP but comparable to TP at 12 months post-surgery except for physical health

0.140 1.25 (±0.707) 0.899 8.50 (±0.92) 8.06 (±1.19) VAS

0.001 33.06 (±15.72) Total SF-36 score

14.00 (±5.47)

0.002

0.004 13.88 (±7.06) 31.56 (±15.90) Mental health

13.50 (±3.92) 31.56 (±15.72) Physical health

p 0.5

30

1.94 (±1.23)

0.878 68.88 (±21.72) 69.50 (±21.15)

0.878

0.736 67.25 (±20.38)

67.63 (±23.38) 66.13 (±19.87)

69.75 (±22.24)

p value ACP TP p value ACP TP

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p 0.0004 p 0.6

1.50 (±1.15)

72.00 (±19.20) 81.81 (±13.36)

69.50 (±18.18)

71.63 (±20.32) 76.94 (±13.32)

82.50 (±15.24)

ACP TP

40

*

Post-operative 3 months

*

Pre-operative SF-36 parameters

Table 12 Health-related quality of life outcomes based on etiology (pre-operative, 3 months post-surgery, 12 months post-surgery)

Post-operative 12 months


(EORTC) QOL questionnaire, the physical status component was also the least affected, but social functioning was the most affected, followed by emotional functioning, which may be due to differences in the questionnaire [15]. Post-operative QOL following Frey’s pancreaticojejunostomy was significantly improved when compared with pre-operative QOL (78.54 vs. 26.7), similar to the other QOL studies after Frey’s pancreaticojejunostomy [15], but significantly less than the general population. Even though the total SF-36 score was lower, the physical function, role physical, general health, role emotional, and mental health scores were comparable with those of the general population. Pre-operatively perceived change in health over a 1-year period was reported to be much worse in 62.5 %, worse in 33.3 %, better in none, and much better in one. This is because these patients were candidates planned for surgery for pain and had multiple and severe attacks of pain affecting day-to-day life. Post-operatively, at 1 year after surgery, the perceived change in health was similar in 4.17 %, better in 29.2 %, and much better in 66.63 %. None reported their change in health as worse. Kalady et al. [30] reported that 58 % reported affirmatively regarding perceived change of health in the previous 1 year, and van Loo et al. [40] reported that 35 % had improved perceived change in health and 40 % had a similar health status. Post-operative QOL at 12 months correlated well with the pain relief in most of the patients in the study. Even in the two subjects with moderate pain, the QOL had improved, suggesting that other factors were also influencing QOL. Most of the alcoholic pancreatitis patients had abstained from alcohol at 12 months follow-up. This observation was also made in other studies [41]. This may be because of relief of pain and improvement of QOL. In the present study, there was insignificant increase in the incidence of steatorrhea at 12 months post-surgery, but this had no

Beger (20) vs. Frey (22), randomized

Frey (31) vs. PPPD (30) randomized

Beger (38) vs. Frey (36)

PPPD (30) vs. Frey (31)

PPPD (40), Frey (16), DP (1), other (18)

Frey’s procedure (24)

Izbicki et al. [15]

Izbicki et al. [42]

Strate et al. [43]

Strate et al. [44]

King et al. [45]

Present study

Prospective

Retrospective

Prospective

Prospective

Prospective

Prospective

Study design

SF-36, VAS

EORTC QLQ-C30, SF-36, PAN-26

EORTC QLQ-C30

EORTC QLQ-C30

EORTC QLQ-C30

VAS, EORTC QLQ-C30

QOL questionnaire

• Significant improvements in the pain scores as denoted 79.98 % decrease in pain

• Significant improvements in SF-36 QOL scores following surgery and comparable to general population in many aspects of QOL after surgery in tropical pancreatitis

• QOL outcomes are similar as measured by SF-36 or EORTC QLQ-C30

• Significant improvement in mental component scores for the SF-36 with trend toward improvement in physical component score

• HR-QOL and pain scores were not different between the groups although a slight tendency to better overall QOL with Frey’s pancreaticojejunostomy • QOL for the EORTC QLQ-C30 was uniformly better than pre-operative values regardless of type of procedure

• No difference in HR-QOL and pain scores between alcohol consumers and non-alcohol consumers post-operatively

• No significant difference in HR-QOL, pain, exocrine or endocrine insufficiency within two groups

• Global QOL was better than pre-operative QOL following Frey’s procedure (58.35 vs. 28.6)

• Median pain score decreased by 90 % in Frey and 71 % in PPPD group

• Global QOL improved by 71 % in Frey and 43 % in PPPD group

• Decrease of pain score by 95 and 94 % after Beger and Frey’s procedure

• Global HR-QOL improved by 67 % in both Beger and Frey groups

Remarks

DP distal pancreatectomy, EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30, HR-QOL health-related quality of life, PPPD pylorus-preserving pancreaticoduodenectomy, QOL quality of life, SF-36 short-form 36-item health survey, VAS visual analog scale

Surgical procedure

Author

Table 13 Comparison of studies on quality of life in chronic pancreatitis following Frey’s pancreaticojejunostomy

Author's personal copy

World J Surg

123


bearing on HR-QOL. Medically managed chronic pancreatitis patients with steatorrhea had poor HR-QOL in all domains [39, 40]. Surgical series like that of Strate et al. [43] describe that, even though their patients experienced exocrine and endocrine insufficiency after surgery, the reported QOL was good, irrespective of pancreatic insufficiency. In the study by Sohn et al. [41], the endocrine and exocrine insufficiency did not adversely affect the longterm survival or patient perception of QOL. Exocrine and endocrine insufficiency had no substantial impact on HRQOL, probably because surgery provided good pain relief, which influenced all aspects of HR-QOL. Table 13 describes different studies on HR-QOL following Frey’s pancreaticojejunostomy in chronic pancreatitis.

Conclusion Frey’s pancreaticojejunostomy effectively reduces pain in tropical pancreatitis, with significant improvement in HRQOL, which is comparable with the general population in most aspects of QOL. As this study has only 12 months of follow-up, large prospective long-term studies are required to assess the effect of surgery on HR-QOL and the natural course of tropical pancreatitis. HR-QOL is vital in proper comparison of treatment options, physician–patient communication and decision making, and indicating prognosis in chronic debilitating diseases like chronic pancreatitis. Therefore, HR-QOL should be an integral part of all future studies.

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