Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy

NCT00915863 | Unknown DMC

• 1 other identifier: WP-0901
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the incidence of complications with the isolated Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of complications with isolated Roux-en-Y reconstruction with those of Billroth-II-type reconstruction after pancreaticoduodenectomy.

Conditions

Pancreatic Neoplasms; Bile Duct Neoplasms; Ampullary Neoplasms; Duodenal Neoplasms; Pancreatitis

Keywords

pancreaticoduodenectomy; pancreatic fistula; reconstruction; isolated Roux-en-Y

Outcome Measures

Primary Outcomes (1)

• the incidence of pancreatic fistula

  3 months after operation

Secondary Outcomes (1)

• the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess

  3 months after operation

Study Arms (2)

Billroth-II-type

ACTIVE COMPARATOR

Billroth-II-type reconstruction after pancreaticoduodenectomy

Procedure: Billroth-II-type reconstruction

Isolated Roux-en-Y

EXPERIMENTAL

Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy

Procedure: Isolated Roux-en-Y type reconstruction

Interventions

Billroth-II-type reconstruction PROCEDURE

surgical procedure

Also known as: Child reconstruction

Billroth-II-type

Isolated Roux-en-Y type reconstruction PROCEDURE

surgical procedure

Also known as: Roux-en-Y reconstruction

Isolated Roux-en-Y

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the patients had undergone pancreatic head resection at Wakayama Medical University the patients obtained appropriate informed consent

You may not qualify if:

• young patients (less than 20-years-old)
• patients with severe complications which were possible to prolong hospital stay
• patients undergone hemodialysis
• patients combined resection of other organs
• patients who were diagnosed inadequacy for this study by a physician
• patients without an informed consent

Sponsors & Collaborators

• Wakayama Medical University: lead

Study Sites (1)

Wakayama Medical University , Second Department of Surgery

811-1 Kimiidera, Wakayama, Wakayama, 641-8510, Japan

RECRUITING

Related Publications (7)

• Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6.

  PMID: 16794381 BACKGROUND

• Tani M, Kawai M, Terasawa H, Ina S, Hirono S, Uchiyama K, Yamaue H. Does postoperative chemotherapy have a survival benefit for patients with pancreatic cancer? J Surg Oncol. 2006 May 1;93(6):485-90. doi: 10.1002/jso.20440.

  PMID: 16615151 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

• Tani M, Onishi H, Kinoshita H, Kawai M, Ueno M, Hama T, Uchiyama K, Yamaue H. The evaluation of duct-to-mucosal pancreaticojejunostomy in pancreaticoduodenectomy. World J Surg. 2005 Jan;29(1):76-9. doi: 10.1007/s00268-004-7507-0.

  PMID: 15592915 BACKGROUND

• Tani M, Kawai M, Terasawa H, Ueno M, Hama T, Hirono S, Ina S, Uchiyama K, Yamaue H. Complications with reconstruction procedures in pylorus-preserving pancreaticoduodenectomy. World J Surg. 2005 Jul;29(7):881-4. doi: 10.1007/s00268-005-7697-0.

  PMID: 15951940 BACKGROUND

• Busquets J, Martin S, Fabregat J, Secanella L, Pelaez N, Ramos E. Randomized trial of two types of gastrojejunostomy after pancreatoduodenectomy and risk of delayed gastric emptying (PAUDA trial). Br J Surg. 2019 Jan;106(1):46-54. doi: 10.1002/bjs.11023. Epub 2018 Dec 3.

  PMID: 30507039 DERIVED

• Tani M, Kawai M, Hirono S, Okada KI, Miyazawa M, Shimizu A, Kitahata Y, Yamaue H. Randomized clinical trial of isolated Roux-en-Y versus conventional reconstruction after pancreaticoduodenectomy. Br J Surg. 2014 Aug;101(9):1084-91. doi: 10.1002/bjs.9544. Epub 2014 Jun 26.

  PMID: 24975853 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Bile Duct Neoplasms; Duodenal Neoplasms; Pancreatitis; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Masaji Tani, MD

  Wakayama Medical University

  STUDY CHAIR

Central Study Contacts

Hiroki Yamaue, MD

CONTACT

81-73-441-0612; yamaue-h@wakayama-med.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: June 8, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: January 26, 2010

Record last verified: 2010-01

Locations

JP (1)