A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction

• ClinicalTrials.gov Identifier: NCT01460550
• Recruitment Status: Unknown
• First Posted: October 27, 2011
• Last Update Posted: April 1, 2015
• Sponsor: Kobe University
• Information provided by (Responsible Party): Ippei Matsumoto, Kobe University

Tracking Information

• First Submitted Date: October 11, 2011
• First Posted Date: October 27, 2011
• Last Update Posted Date: April 1, 2015
• Study Start Date: November 2011
• Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2011)

Incident rate of delayed gastric emptying [ Time Frame: during hospital stay after surgery, an expected average of 3 weeks ]

DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction
• Official Title: Comparison Between Antecolic and Retrocolic Gastrointestinal Reconstruction in Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Controlled Multicenter Trial
• Brief Summary: The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.

Detailed Description

The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction. Delayed gastric emptying after pancreaticoduodenectomy is important to affect the postoperative course and QOL. We conducted a prospective randomized trial on 240 patients who underwent pancreaticoduodenectomy for comparing between antecolic and retrocolic gastrointestinal reconstruction.

The primary endpoint was defined as incidence of delayed gastric emptying by ISGPS criteria. The secondary endpoint was defined as incidence of other postoperative morbidity. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated for pancreatic head and periampullary disease, and an appropriate informed consent was obtained. Exclusion criteria was 1) patients who have the history of gastrectomy, 2) patients who have severe cardiorespiratory dysfunction, 3) patients who have liver cirrhosis or are receiving dialysis, and 4) patients who were diagnosed inadequate for this study by a physician.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Postprocedural Delayed Gastric Emptying

Intervention

• Procedure: Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy
  The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the retrocolic reconstruction, the jejunal loop was anastomosed to the duodenum or stomach through a separate mesocolic window on the left of the middle colic vessels.
• Procedure: Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy
  The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the antecolic reconstruction, the jejunal loop about 30 cm distal to the hepaticojejunostomy, was brought up anterior to the transverse colon and anastomosed to the duodenum or stomach.

Study Arms

Experimental: gastrointestinal reconstruction

Interventions:

• Procedure: Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy
• Procedure: Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy

Publications *

• DeOliveira ML, Winter JM, Schafer M, Cunningham SC, Cameron JL, Yeo CJ, Clavien PA. Assessment of complications after pancreatic surgery: A novel grading system applied to 633 patients undergoing pancreaticoduodenectomy. Ann Surg. 2006 Dec;244(6):931-7; discussion 937-9.
• Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Büchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8.
• Akizuki E, Kimura Y, Nobuoka T, Imamura M, Nagayama M, Sonoda T, Hirata K. Reconsideration of postoperative oral intake tolerance after pancreaticoduodenectomy: prospective consecutive analysis of delayed gastric emptying according to the ISGPS definition and the amount of dietary intake. Ann Surg. 2009 Jun;249(6):986-94. doi: 10.1097/SLA.0b013e3181a63c4c.
• Welsch T, Borm M, Degrate L, Hinz U, Büchler MW, Wente MN. Evaluation of the International Study Group of Pancreatic Surgery definition of delayed gastric emptying after pancreatoduodenectomy in a high-volume centre. Br J Surg. 2010 Jul;97(7):1043-50. doi: 10.1002/bjs.7071.
• Hayashibe A, Kameyama M, Shinbo M, Makimoto S. The surgical procedure and clinical results of subtotal stomach preserving pancreaticoduodenectomy (SSPPD) in comparison with pylorus preserving pancreaticoduodenectomy (PPPD). J Surg Oncol. 2007 Feb 1;95(2):106-9.
• Hashimoto Y, Traverso LW. Incidence of pancreatic anastomotic failure and delayed gastric emptying after pancreatoduodenectomy in 507 consecutive patients: use of a web-based calculator to improve homogeneity of definition. Surgery. 2010 Apr;147(4):503-15. doi: 10.1016/j.surg.2009.10.034. Epub 2009 Dec 16.
• Park JS, Hwang HK, Kim JK, Cho SI, Yoon DS, Lee WJ, Chi HS. Clinical validation and risk factors for delayed gastric emptying based on the International Study Group of Pancreatic Surgery (ISGPS) Classification. Surgery. 2009 Nov;146(5):882-7. doi: 10.1016/j.surg.2009.05.012. Epub 2009 Jul 18.
• Tran KT, Smeenk HG, van Eijck CH, Kazemier G, Hop WC, Greve JW, Terpstra OT, Zijlstra JA, Klinkert P, Jeekel H. Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors. Ann Surg. 2004 Nov;240(5):738-45.
• Akizuki E, Kimura Y, Nobuoka T, Imamura M, Nishidate T, Mizuguchi T, Furuhata T, Hirata K. Prospective nonrandomized comparison between pylorus-preserving and subtotal stomach-preserving pancreaticoduodenectomy from the perspectives of DGE occurrence and postoperative digestive functions. J Gastrointest Surg. 2008 Jul;12(7):1185-92. doi: 10.1007/s11605-008-0513-z. Epub 2008 Apr 22.
• Murakami H, Suzuki H, Nakamura T. Pancreatic fibrosis correlates with delayed gastric emptying after pylorus-preserving pancreaticoduodenectomy with pancreaticogastrostomy. Ann Surg. 2002 Feb;235(2):240-5.
• Riediger H, Makowiec F, Schareck WD, Hopt UT, Adam U. Delayed gastric emptying after pylorus-preserving pancreatoduodenectomy is strongly related to other postoperative complications. J Gastrointest Surg. 2003 Sep-Oct;7(6):758-65.
• Horstmann O, Markus PM, Ghadimi MB, Becker H. Pylorus preservation has no impact on delayed gastric emptying after pancreatic head resection. Pancreas. 2004 Jan;28(1):69-74.
• Yeo CJ, Cameron JL, Lillemoe KD, Sohn TA, Campbell KA, Sauter PK, Coleman J, Abrams RA, Hruban RH. Pancreaticoduodenectomy with or without distal gastrectomy and extended retroperitoneal lymphadenectomy for periampullary adenocarcinoma, part 2: randomized controlled trial evaluating survival, morbidity, and mortality. Ann Surg. 2002 Sep;236(3):355-66; discussion 366-8.
• Park YC, Kim SW, Jang JY, Ahn YJ, Park YH. Factors influencing delayed gastric emptying after pylorus-preserving pancreatoduodenectomy. J Am Coll Surg. 2003 Jun;196(6):859-65.
• Chijiiwa K, Imamura N, Ohuchida J, Hiyoshi M, Nagano M, Otani K, Kai M, Kondo K. Prospective randomized controlled study of gastric emptying assessed by (13)C-acetate breath test after pylorus-preserving pancreaticoduodenectomy: comparison between antecolic and vertical retrocolic duodenojejunostomy. J Hepatobiliary Pancreat Surg. 2009;16(1):49-55. doi: 10.1007/s00534-008-0004-3. Epub 2008 Dec 16.
• Hartel M, Wente MN, Hinz U, Kleeff J, Wagner M, Müller MW, Friess H, Büchler MW. Effect of antecolic reconstruction on delayed gastric emptying after the pylorus-preserving Whipple procedure. Arch Surg. 2005 Nov;140(11):1094-9.
• Nikfarjam M, Kimchi ET, Gusani NJ, Shah SM, Sehmbey M, Shereef S, Staveley-O'Carroll KF. A reduction in delayed gastric emptying by classic pancreaticoduodenectomy with an antecolic gastrojejunal anastomosis and a retrogastric omental patch. J Gastrointest Surg. 2009 Sep;13(9):1674-82. doi: 10.1007/s11605-009-0944-1. Epub 2009 Jun 23.
• Tani M, Terasawa H, Kawai M, Ina S, Hirono S, Uchiyama K, Yamaue H. Improvement of delayed gastric emptying in pylorus-preserving pancreaticoduodenectomy: results of a prospective, randomized, controlled trial. Ann Surg. 2006 Mar;243(3):316-20.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 25, 2011): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2017
• Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy

Exclusion Criteria:

• patients who have the history of gastrectomy
• patients who have severe cardiorespiratory dysfunction
• patients who have liver cirrhosis or are receiving dialysis
• patients who were diagnosed inadequacy for this study by a physician

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01460550
• Other Study ID Numbers: KOPAS01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ippei Matsumoto, Kobe University
• Study Sponsor: Kobe University
• Collaborators: Not Provided

Investigators

• Study Chair: Yonson Ku, MD; Kobe University

• PRS Account: Kobe University
• Verification Date: March 2015