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

NCT01460550 | Unknown Phase 3 DMC

• 1 other identifier: KOPAS01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprocedural Delayed Gastric Emptying

Keywords

delayed gastric emptying(DGE); pancreaticoduodenectomy(PD); randomized controlled trial(RCT); gastro- or duodeno- jejunostomy reconstruction; morbidity

Outcome Measures

Primary Outcomes (1)

• Incident rate of delayed gastric emptying

  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.

  during hospital stay after surgery, an expected average of 3 weeks

Study Arms (1)

gastrointestinal reconstruction

EXPERIMENTAL

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

Interventions

Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy PROCEDURE

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.

gastrointestinal reconstruction

Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy PROCEDURE

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.

gastrointestinal reconstruction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Kobe University: lead

Study Sites (1)

Kobe University

Kobe, Hyōgo, 6500017, Japan

RECRUITING

Related Publications (19)

• 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. doi: 10.1097/01.sla.0000246856.03918.9a.

  PMID: 17122618 BACKGROUND

• Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler 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. doi: 10.1016/j.surg.2007.05.005.

  PMID: 17981197 BACKGROUND

• 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.

  PMID: 19474680 BACKGROUND

• Welsch T, Borm M, Degrate L, Hinz U, Buchler 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.

  PMID: 20632270 BACKGROUND

• 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. doi: 10.1002/jso.20608.

  PMID: 17262740 BACKGROUND

• 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.

  PMID: 20018335 BACKGROUND

• 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.

  PMID: 19744455 BACKGROUND

• 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. doi: 10.1097/01.sla.0000143248.71964.29.

  PMID: 15492552 BACKGROUND

• 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.

  PMID: 18427904 BACKGROUND

• 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. doi: 10.1097/00000658-200202000-00012.

  PMID: 11807364 BACKGROUND

• 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. doi: 10.1016/s1091-255x(03)00109-4.

  PMID: 13129553 BACKGROUND

• 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. doi: 10.1097/00006676-200401000-00011.

  PMID: 14707733 BACKGROUND

• 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. doi: 10.1097/00000658-200209000-00012.

  PMID: 12192322 BACKGROUND

• 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. doi: 10.1016/S1072-7515(03)00127-3.

  PMID: 12788421 BACKGROUND

• 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.

  PMID: 19083149 BACKGROUND

• Hartel M, Wente MN, Hinz U, Kleeff J, Wagner M, Muller MW, Friess H, Buchler MW. Effect of antecolic reconstruction on delayed gastric emptying after the pylorus-preserving Whipple procedure. Arch Surg. 2005 Nov;140(11):1094-9. doi: 10.1001/archsurg.140.11.1094.

  PMID: 16301447 BACKGROUND

• 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.

  PMID: 19548039 BACKGROUND

• 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. doi: 10.1097/01.sla.0000201479.84934.ca.

  PMID: 16495694 BACKGROUND

• Toyama H, Matsumoto I, Mizumoto T, Fujita H, Tsuchida S, Kanbara Y, Kadowaki Y, Maeda H, Okano K, Fukuoka M, Takase S, Shirakawa S, Terai S, Mukubo H, Ishida J, Yamashita H, Ueno K, Tanaka M, Kido M, Ajiki T, Murakami S, Nishimura K, Fukumoto T. Influence of the Retrocolic Versus Antecolic Route for Alimentary Tract Reconstruction on Delayed Gastric Emptying After Pancreatoduodenectomy: A Multicenter, Noninferiority Randomized Controlled Trial. Ann Surg. 2021 Dec 1;274(6):935-944. doi: 10.1097/SLA.0000000000004072.

  PMID: 32773628 DERIVED

Related Links

• Click here for more information about this study: Clinical Trial of DGE after PD

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yonson Ku, MD

  Kobe University

  STUDY CHAIR

Central Study Contacts

Ippei Matsumoto, MD

CONTACT

+81-78-382-6302; imatsu@med.kobe-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 27, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

JP (1)