PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial

Christopher Halloran1, Kellie Platt2, Abbie Gerard2, Fotis Polydoros2, Derek O’Reilly3, Dhanny Gomez4, Andrew M. Smith5, John P. Neoptolemos2, Zahir Soonwalla6, Taylor Mb7, Jane Blazeby8, Paula Ghaneh2
1National Institutes of Health Research Liverpool Pancreas Biomedical Research Unit and Clinical Directorate of General Surgery, Royal Liverpool and Broadgreen University Hospitals NHS Trust and the University of Liverpool, Liverpool, L69 3GA, UK
2Cancer Research UK Liverpool Cancer Trials Unit, University of Liverpool, Block C Waterhouse Building, 1-3 Brownlow Street, Liverpool, L69 3GL, UK
3Department of Surgery, Manchester Royal Infirmary, Oxford Rd, Manchester, M13 9WL, UK
4Queen’s Medical Center, Derby Road, Nottingham, NG7 2UH, UK
5Department of Pancreatic Surgery, Abdominal Medicine and Surgery CSU, St James’s University Hospital, 3rd Floor Bexley Wing, Leeds, LS9 7TF, UK
6Churchill Hospital, Oxford University Hospitals NHS Trust, Headington, Oxford, OX3 7LJ, UK
7Mater Hospital, Belfast Health and Social care Trust, Crumlin Rd, Belfast, BT12 6AB, UK
8Bristol Center for Surgical Research, School of Social and Community Medicine, University of Bristol, BS8 2PS and University Hospitals Bristol NHS Foundation Trust, Bristol, BS2 8HW, UK

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Kausch W. Das carcinom der papilla duodeni und seine radikale Entfernung. Beitr Z Klin Chir. 1912;78:439–86.

Jones L, Russell C, Mosca F, Boggi U, Sutton R, Slavin J, et al. Standard Kausch-Whipple pancreatoduodenectomy. Dig Surg. 1999;16:297–304.

Whipple AO. Observations on radical surgery for lesions of pancreas. Surg Gynecol Obstet. 1946;82:623–31.

Trimble IR, Parsons JW, Sherman CP. A one stage operation for cure of carcinoma of the ampulla of Vater and of the head of the pancreas. Surg Gynecol Obstet. 1941;73:711–22.

Watson K. Carcinoma of the ampulla of Vater: successful radical resection. Br J Surg. 1944;31:368–73.

Traverso LW, Longmire Jr WP. Preservation of the pylorus in pancreatoduodenectomy. Surg Gynecol Obstet. 1978;146:959–62.

Pitt HA. Curative treatment for pancreatic neoplasms: standard resection. Surg Clin North Am. 1995;75:891–904.

Seiler CA, Wagner M, Bachmann T, Redaelli CA, Schmied B, Uhl W, et al. Randomized clinical trial of pylorus-preserving duodenopancreatectomy versus classical Whipple resection-long term results. Br J Surg. 2005;92:547–56.

Diener MK, Knaebel H-P, Heukaufer C, Antes G, Büchler MW, Seiler CM. A systematic review and meta-analysis of pylorus-preserving versus classical pancreaticoduodenectomy for surgical treatment of periampullary and pancreatic carcinoma. Ann Surg. 2007;245:187–200.

Diener MK, Heukaufer C, Schwarzer G, Seiler CM, Antes G, Buchler MW, et al. Pancreaticoduodenectomy (classic Whipple) versus pylorus-preserving pancreaticoduodenectomy (pp Whipple) for surgical treatment of periampullary and pancreatic carcinoma. Cochrane Database Syst Rev. 2008;16, CD006053.

Alexakis N, Halloran C, Raraty M, Ghaneh P, Sutton R, Neoptolemos JP. Current standards of surgery for pancreatic cancer. Br J Surg. 2004;91:1410–27.

Halloran CM, Ghaneh P, Bosonnet L, Hartley MN, Sutton R, Neoptolemos JP. Complications of pancreatic cancer resection. Dig Surg. 2002;19:138–46.

Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, et al. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005;138:8–13.

Edge SB, Schmieg Jr RE, Rosenlof LK, Wilhelm MC. Pancreatic cancer resectional outcome in American University Centers in 1988–1990. Cancer. 1993;71:3502–8.

Gordon TA, Bowman HM, Tielsch JM, Bass EB, Burleyson GP, Cameron JL. Statewide regionalization of pancreaticoduodenectomy and its effect on in-hospital mortality. Ann Surg. 1998;228:71–8.

Rosenberg L, MacNeil P, Turcotte L. Economic evaluation of the use of octreotide for prevention of complications following pancreatic resection. J Gastrointest Surg. 1999;3:225–32.

Schaefer CJ. Cost and outcome of the Whipple procedure. Ann Surg. 1995;222:211–2.

Rosemurgy A, Cowgill S, Coe B, Thomas A, Al-Saadi S, Goldin S, et al. Frequency with which surgeons undertake pancreaticoduodenectomy continues to determine length of stay, hospital charges, and in-hospital mortality. J Gastrointest Surg. 2008;12:442–9.

Tran K, Van Eijck C, Di Carlo V, Hop WCJ, Zerbi A, Balzano G, et al. Occlusion of the pancreatic duct versus pancreaticojejunostomy: a prospective randomized trial. Ann Surg. 2002;236:422–8. discussion 428.

Kleespies A, Albertsmeier M, Obeidat F, Seeliger H, Jauch K-W, Bruns CJ. The challenge of pancreatic anastomosis. Langenbecks Arch Surg. 2008;393:459–71.

McKay A, Mackenzie S, Sutherland FR, Bathe OF, Doig C, Dort J, et al. Meta-analysis of pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy. Br J Surg. 2006;93:929–36.

Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, et al. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007;193:171–83.

Xiong JJ, Tan CL, Szatmary P, Huang W, Ke NW, Hu WM, et al. Meta-analysis of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy. Br J Surg. 2014;101:1196–208.

Bassi C, Falconi M, Molinari E, Mantovani W, Butturini G, Gumbs AA, et al. Duct-to-mucosa versus end-to-side pancreaticojejunostomy reconstruction after pancreaticoduodenectomy: results of a prospective randomized trial. Surgery. 2003;134:766–71.

Berger AC, Howard TJ, Kennedy EP, Sauter PK, Bower-Cherry M, Dutkevitch S, et al. Does type of pancreaticojejunostomy after pancreaticoduodenectomy decrease rate of pancreatic fistula? A randomized, prospective, dual-institution trial. J Am Coll Surg. 2009;208:738–47. discussion 747–9.

Langrehr JM, Bahra M, Jacob D, Glanemann M, Neuhaus P. Prospective randomized comparison between a new mattress technique and Cattell (duct-to-mucosa) pancreaticojejunostomy for pancreatic resection. World J Surg. 2005;29:1111–9. discussion 1120–1.

Peng SY, Wang JW, Lau WY, Cai XJ, Mou YP, Liu YB, et al. Conventional versus binding pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized trial. Ann Surg. 2007;245:692–8.

Batignani G, Fratini G, Zuckermann M, Bianchini E, Tonelli F. Comparison of Wirsung-jejunal duct-to-mucosa and dunking technique for pancreatojejunostomy after pancreatoduodenectomy. Hepatobiliary Pancreat Dis Int. 2005;4:450–5.

You D, Jung K, Lee H, Heo J, Choi S, Choi D. Comparison of different pancreatic anastomosis techniques using the definitions of the International Study Group of Pancreatic Surgery: a single surgeon’s experience. Pancreas. 2009;38:896–902.

Satoi S, Toyokawa H, Yanagimoto H, Yamamoto T, Yamao J, Kim S, et al. A new guideline to reduce postoperative morbidity after pancreaticoduodenectomy. Pancreas. 2008;37:128–33.

Lee SE, Yang SH, Jang J-Y, Kim S-W. Pancreatic fistula after pancreaticoduodenectomy: a comparison between the two pancreaticojejunostomy methods for approximating the pancreatic parenchyma to the jejunal seromuscular layer: interrupted vs continuous stitches. World J Gastroenterol. 2007;13:5351–6.

Fragulidis GP, Arkadopoulos N, Vassiliou I, Marinis A, Theodosopoulos T, Stafyla V, et al. Pancreatic leakage after pancreaticoduodenectomy: the impact of the isolated jejunal loop length and anastomotic technique of the pancreatic stump. Pancreas. 2009;38:e177–82.

Grobmyer SR, Kooby D, Blumgart LH, Hochwald SN. Novel pancreaticojejunostomy with a low rate of anastomotic failure-related complications. J Am Coll Surg. 2010;210:54–9.

Mishra PK, Saluja SS, Gupta M, Rajalingam R, Pattnaik P. Blumgart’s technique of pancreaticojejunostomy: an appraisal. Dig Surg. 2011;28:281–7.

Kleespies A, Rentsch M, Seeliger H, Albertsmeier M, Jauch K-W, Bruns CJ. Blumgart anastomosis for pancreaticojejunostomy minimizes severe complications after pancreatic head resection. Br J Surg. 2009;96:741–50.

Asbun HJ, Conlon K, Fernandez-Cruz L, Friess H, Shrikhande SV, Adham M, et al. When to perform a pancreatoduodenectomy in the absence of positive histology? A consensus statement by the International Study Group of Pancreatic Surgery. Surgery. 2014;155:887–92.

Blencowe N, Mills N, Whiting P, Blazeby J. Providing adequate and practical descriptions in surgical trials. BMJ (Clinical research ed). 2013;347:f6143.

Blencowe N, Boddy A, Harris A, Hanna T, Whiting P, Cook J, et al. Accounting for intervention complexity in rcts in surgery: new approaches for intervention definition and methods for monitoring fidelity. Trials. 2013;14(suppl):O86.

Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007;142:761–8.

Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992;13:606–8.

Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, et al. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142:20–5.

Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309:814–22.

Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–13.

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg (London, England). 2012;10:28–55.

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63:e1–37.