Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): Design and rationale of a randomized trial

BMC Gastroenterology

Volumn 13, Issue 1, 2013, Pages

  Ahmed Ali, Usama ^a,b   Issa, Yama ^a   Bruno, Marco J ^c   van Goor, Harry ^d   van Santvoort, Hjalmar ^b   Busch, Olivier R C ^a   Dejong, Cornelis H C ^e   Nieuwenhuijs, Vincent B ^f,g   van Eijck, Casper H ^c   van Dullemen, Hendrik M ^g   Fockens, Paul ^a   Siersema, Peter D ^b   Gouma, Dirk J ^a   van Hooft, Jeanin E ^a   Keulemans, Yolande ^e   Poley, Jan W ^c   Timmer, Robin ^h   Besselink, Marc G ^a   Vleggaar, Frank P ^b   Wilder Smith, Oliver H ^d   Gooszen, Hein G ^d   Dijkgraaf, Marcel G W ^a   Boermeester, Marja A ^a   more..

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

^d RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^e MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^f Isala Klinik   (Netherlands)

^g UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^h ST ANTONIUS HOSPITAL   (Netherlands)

Author keywords

Chronic pancreatitis; Endoscopic treatment; Endoscopy; ERCP; Frey procedure; Opioid; Pain; Pancreaticojejunostomy; Surgery; Surgical management

Indexed keywords

ADULT; ARTICLE; CHRONIC PANCREATITIS; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; COST BENEFIT ANALYSIS; EARLY INTERVENTION; ENDOSCOPIC SURGERY; EXPERIMENTAL DESIGN; FEMALE; FOLLOW UP; HUMAN; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PAIN ASSESSMENT; PANCREAS SURGERY; PANCREATICOJEJUNOSTOMY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SURGICAL RISK;

ADULT; AGED; AGED, 80 AND OVER; EARLY MEDICAL INTERVENTION; FOLLOW-UP STUDIES; HEALTH CARE COSTS; HUMANS; LENGTH OF STAY; MIDDLE AGED; PAIN MEASUREMENT; PANCREAS; PANCREATICOJEJUNOSTOMY; PANCREATITIS, CHRONIC; QUALITY OF LIFE; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME;

EID: 84875070925     PISSN: None     EISSN: 1471230X     Source Type: Journal    
DOI: 10.1186/1471-230X-13-49     Document Type: Article

References (37)

1. Miyake H, Harada H, Kunichika K, Ochi K, Kimura I. Clinical course and prognosis of chronic pancreatitis. Pancreas 1987, 2:378-385.
2. Thorsgaard PN, Nyboe AB, Pedersen G, Worning H. Chronic pancreatitis in Copenhagen. A retrospective study of 64 consecutive patients. Scand J Gastroenterol 1982, 17:925-931.
3. Ammann RW, Akovbiantz A, Largiader F, Schueler G. Course and outcome of chronic pancreatitis. Longitudinal study of a mixed medical-surgical series of 245 patients. Gastroenterology 1984, 86:820-828.
4. Lankisch PG. Natural course of chronic pancreatitis. Pancreatology 2001, 1:3-14.
5. Witt H, Apte MV, Keim V, Wilson JS. Chronic pancreatitis: challenges and advances in pathogenesis, genetics, diagnosis, and therapy. Gastroenterology 2007, 132:1557-1573.
6. American Gastroenterological Association (AMA) American gastroenterological association medical position statement: treatment of pain in chronic pancreatitis. Gastroenterology 1998, 115:763-764. American Gastroenterological Association (AMA).
7. van Esch AA, Wilder-Smith OH, Jansen JB, van Goor H, Drenth JP. Pharmacological management of pain in chronic pancreatitis. Dig Liver Dis 2006, 38:518-526.
8. Ammann RW, Muellhaupt B. The natural history of pain in alcoholic chronic pancreatitis. Gastroenterology 1999, 116:1132-1140.
9. Lieb JG, Forsmark CE. Pain and chronic pancreatitis. Aliment Pharmacol Ther 2009, 29:706-719.
10. Lamme B, Boermeester MA, Straatsburg IH, van Buijtenen JM, Boerma D, Offerhaus GJ, Gouma DJ, van Gulik TM. Early versus late surgical drainage for obstructive pancreatitis in an experimental model. Br J Surg 2007, 94:849-854.
11. Maartense S, Ledeboer M, Bemelman WA, Ringers J, Frolich M, Masclee AA. Effect of surgery for chronic pancreatitis on pancreatic function: pancreatico-jejunostomy and duodenum-preserving resection of the head of the pancreas. Surgery 2004, 135:125-130.
12. Nealon WH, Townsend CM, Thompson JC. Operative drainage of the pancreatic duct delays functional impairment in patients with chronic pancreatitis. A prospective analysis. Ann Surg 1988, 208:321-329.
13. Nealon WH, Thompson JC. Progressive loss of pancreatic function in chronic pancreatitis is delayed by main pancreatic duct decompression. A longitudinal prospective analysis of the modified puestow procedure. Ann Surg 1993, 217:458-466.
14. Ahmed AU, Nieuwenhuijs VB, van Eijck CH, Gooszen HG, van Dam RM, Busch OR, Dijkgraaf MG, Mauritz FA, Jens S, Mast J, van Goor H, Boermeester MA. Clinical outcome in relation to timing of surgery in chronic pancreatitis: a nomogram to predict pain relief. Arch Surg 2012, 147:925-932.
15. Ahmed AU, Pahlplatz JM, Nealon WH, van Goor H, Gooszen HG, Boermeester MA. Endoscopic or surgical intervention for painful obstructive chronic pancreatitis. Cochrane Database Syst Rev 2012, 1:CD007884.
16. Schneider A, Lohr JM, Singer MV. The M-ANNHEIM classification of chronic pancreatitis: introduction of a unifying classification system based on a review of previous classifications of the disease. J Gastroenterol 2007, 42:101-119.
17. Cahen DL, Gouma DJ, Nio Y, Rauws EA, Boermeester MA, Busch OR, Stoker J, Lameris JS, Dijkgraaf MG, Huibregtse K, Bruno MJ. Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis. N Engl J Med 2007, 356:676-684.
18. Partington P, Rochelle R. Modified Puestow procedure for retrograde drainage of the pancreatic duct. Ann Surg 1960, 152:1037-1043.
19. Frey C, Smith G. Description and rationale of a new operation for chronic pancreatitis. Pancreas 1987, 2:701-707.
20. Van der Kuy A. Farmacotherapeutisch Kompas [Pharmacotherapeutic Compass] 2008, Amstelveen: College voor zorgverzekeringen (CvZ) [Health Insurance Board].
21. CBO (Kwaliteitsorgaan voor de gezondheidszorg)/VIKC Richtlijn Pijn bij patiënten met kanker 2008, Utrecht: Centraal BegeleidingsOrgaan (CBO), CBO (Kwaliteitsorgaan voor de gezondheidszorg)/VIKC.
22. Izbicki JR, Bloechle C, Broering DC, Knoefel WT, Kuechler T, Broelsch CE. Extended drainage versus resection in surgery for chronic pancreatitis: a prospective randomized trial comparing the longitudinal pancreaticojejunostomy combined with local pancreatic head excision with the pylorus-preserving pancreatoduodenectomy. Ann Surg 1998, 228:771-779.
23. The EuroQol Group EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208. The EuroQol Group.
24. Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 1992, 305:160-164.
25. Rutten GEHM, De Grauw WJC, Nijpels G, Goudswaard AN, Uitewaal PJM, Van der Does FEE, Heine RJ, Van Ballegooie E, Verduijn MM, Bouma M. NHG-standaard diabetes mellitus type 2 [Diabetes mellitus type 2 guidelines of the Dutch general practitioner association]. Huisarts Wet 2006, 49:137-152.
26. Muller MW, Friess H, Martin DJ, Hinz U, Dahmen R, Buchler MW. Long-term follow-up of a randomized clinical trial comparing Beger with pylorus-preserving Whipple procedure for chronic pancreatitis. Br J Surg 2008, 95:350-356.
27. Mossner J. Guidelines for Chronic Pancreatitis 2009, European Pancreatic Club (EPC).
28. Spanier BW, Dijkgraaf MG, Bruno MJ. Epidemiology, aetiology and outcome of acute and chronic pancreatitis: an update. Best Pract Res Clin Gastroenterol 2008, 22:45-63.
29. Tinto A, Lloyd DA, Kang JY, Majeed A, Ellis C, Williamson RC, Maxwell JD. Acute and chronic pancreatitis-diseases on the rise: a study of hospital admissions in England 1989/90-1999/2000. Aliment Pharmacol Ther 2002, 16:2097-2105.
30. Nealon WH, Matin S. Analysis of surgical success in preventing recurrent acute exacerbations in chronic pancreatitis. Ann Surg 2001, 233:793-800.
31. Layer P, Yamamoto H, Kalthoff L, Clain JE, Bakken LJ, DiMagno EP. The different courses of early- and late-onset idiopathic and alcoholic chronic pancreatitis. Gastroenterology 1994, 107:1481-1487.
32. Devane D, Begley CM, Clarke M. How many do I need? Basic principles of sample size estimation. J Adv Nurs 2004, 47:297-302.
33. Karlsson J, Engebretsen L, Dainty K. Considerations on sample size and power calculations in randomized clinical trials. Arthroscopy 2003, 19:997-999.
34. Besselink MG, van Santvoort HC, Buskens E, Boermeester MA, van Goor H, Timmerman HM, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ, Rosman C, Ploeg RJ, Brink MA, Schaapherder AF, Dejong CH, Wahab PJ, van Laarhoven CJ, van der Harst E, van Eijck CH, Cuesta MA, Akkermans LM, Gooszen HG. Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial. Lancet 2008, 371:651-659.
35. Bakker OJ, van Santvoort HC, van Brunschot S, Geskus RB, Besselink MG, Bollen TL, van Eijck CH, Fockens P, Hazebroek EJ, Nijmeijer RM, Poley JW, van Ramshorst B, Vleggaar FP, Boermeester MA, Gooszen HG, Weusten BL, Timmer R. Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial. JAMA 2012, 307:1053-1061.
36. van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Lameris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med 2010, 362:1491-1502.
37. van der Gaag NA, van Gulik TM, Busch OR, Sprangers MA, Bruno MJ, Zevenbergen C, Gouma DJ, Boermeester MA. Functional and medical outcomes after tailored surgery for pain due to chronic pancreatitis. Ann Surg 2012, 255:763-770.