Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Wakayama Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00915863
First received: May 22, 2009
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Pancreatic Neoplasms
Bile Duct Neoplasms
Ampullary Neoplasms
Duodenal Neoplasms
Pancreatitis
Procedure: Billroth-II-type reconstruction
Procedure: Isolated Roux-en-Y type reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Comparing Isolated Roux-en-Y Reconstruction With Billroth-II-type Reconstruction After Pancreaticoduodenectomy

Resource links provided by NLM:


Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • the incidence of pancreatic fistula [ Time Frame: 3 months after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess [ Time Frame: 3 months after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Billroth-II-type
Billroth-II-type reconstruction after pancreaticoduodenectomy
Procedure: Billroth-II-type reconstruction
surgical procedure
Other Name: Child reconstruction
Experimental: Isolated Roux-en-Y
Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy
Procedure: Isolated Roux-en-Y type reconstruction
surgical procedure
Other Name: Roux-en-Y reconstruction

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915863

Contacts
Contact: Hiroki Yamaue, MD 81-73-441-0612 yamaue-h@wakayama-med.ac.jp

Locations
Japan
Wakayama Medical University , Second Department of Surgery Recruiting
811-1 Kimiidera, Wakayama, Wakayama, Japan, 641-8510
Contact: Hiroki Yamaue, MD    +81-73-441-0612    yamaue-h@wakayama-med.ac.jp   
Contact: Masaji Tani, MD    +81-73-441-0613    matani@wakayama-med.ac.jp   
Principal Investigator: Masaji Tani, MD         
Sponsors and Collaborators
Wakayama Medical University
Investigators
Study Chair: Masaji Tani, MD Wakayama Medical University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00915863     History of Changes
Other Study ID Numbers: WP-0901
Study First Received: May 22, 2009
Last Updated: January 25, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wakayama Medical University:
pancreaticoduodenectomy
pancreatic fistula
reconstruction
isolated Roux-en-Y

Additional relevant MeSH terms:
Duodenal Neoplasms
Neoplasms
Pancreatitis
Pancreatic Neoplasms
Bile Duct Neoplasms
Pancreatic Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014