Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy

NCT ID: NCT00915863

Last Updated: 2010-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-03-31

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.

Detailed Description

The purpose of this study is to clarify whether isolated Roux-en-Y reconstruction declines the incidence of postoperative complications after pancreaticoduodenectomy compared with Billroth-II-type reconstruction. Especially, it is important to decline the incidence of pancreatic fistula, because pancreatic fistula affects a postoperative course. However, there is no report that demonstrated postoperative complications of isolated Roux-en-Y compared with those of Billroth-II-type reconstruction. We conducted a prospective randomized trial on patients who underwent pancreaticoduodenectomy.

Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Wakayama Medical University Hospital.

The primary endpoint was defined as the incidence of pancreatic fistula. The secondary endpoints were the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital (WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Billroth-II-type

Billroth-II-type reconstruction after pancreaticoduodenectomy

Group Type: ACTIVE_COMPARATOR

Billroth-II-type reconstruction

Intervention Type: PROCEDURE

surgical procedure

Isolated Roux-en-Y

Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy

Group Type: EXPERIMENTAL

Isolated Roux-en-Y type reconstruction

Intervention Type: PROCEDURE

surgical procedure

Interventions

Billroth-II-type reconstruction

surgical procedure

Intervention Type: PROCEDURE

Isolated Roux-en-Y type reconstruction

surgical procedure

Intervention Type: PROCEDURE

Other Intervention Names

Child reconstruction; Roux-en-Y reconstruction

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wakayama Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wakayama Medical University

Principal Investigators

Masaji Tani, MD

Role: STUDY_CHAIR

Wakayama Medical University

Locations

Wakayama Medical University , Second Department of Surgery

811-1 Kimiidera, Wakayama, Wakayama, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Hiroki Yamaue, MD

Role: CONTACT

yamaue-h@wakayama-med.ac.jp

81-73-441-0612

Facility Contacts

Hiroki Yamaue, MD

Role: primary

yamaue-h@wakayama-med.ac.jp

+81-73-441-0612

Masaji Tani, MD

Role: backup

matani@wakayama-med.ac.jp

+81-73-441-0613

References

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.

Reference Type: BACKGROUND

PMID: 16794381 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16615151 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16495694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15592915 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15951940 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30507039 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24975853 (View on PubMed)

Other Identifiers

WP-0901

Identifier Type: -

Identifier Source: org_study_id