Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

July 20, 2016 updated by: Hiroki Yamaue, Wakayama Medical University

Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy

The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.

Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.

The primary endpoint in this trial was defined as the incidence of pancreatic fistula .

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Wakayama, Japan, 641-8510
        • Second Department of Surgery, Wakayama Medical University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. disease of pancreatic body and tail
  2. PS (ECOG Performance Status Scale):0-1
  3. Age: 20 years or older
  4. distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis.
  5. Adequate organ functions filled the following criteria within two weeks from enrollment:

1.White blood cell： >3,500/mm3 or <12,000/mm3 2.Neutrophilic leukocyte >2,000/mm3 3.Platelet>100,000/mm3 4.Hemoglobin > 9.0g/dL 5.Total bilirubin <2.0mg/dL 6.AST and ALT<150IU/L 7.Creatinine <1.5mg/dL 6)Patients who can provide written informed consent

Exclusion Criteria:

  1. Patients with severe liver cirrhosis or active hepatitis
  2. Patients with respiratory illness that requires oxygen administration
  3. .Patients with chronic renal failure requiring dialysis
  4. Patients with active duplicative malignant disease affecting adverse event
  5. Others, patients who are unfit for the study as determined by the attending physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Roux-en-Y anastomosis of the pancreatic stump
end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
Procedure: Roux-en-Y anastomosis of the pancreatic stump
end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
Active Comparator: Stapling closure of the pancreatic stump
Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples.
Procedure: Stapling closure of the pancreatic stump
Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of pancreatic fistula defined by ISGPF classification
Time Frame: 3 month after operation
3 month after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
morbidity
Time Frame: 3 months after opeartion
3 months after opeartion
postoperative hospital stay
Time Frame: 3 month after operation
3 month after operation
quality of life
Time Frame: 2 years after operation
2 years after operation
new onset or worsening diabetes
Time Frame: 2 years after opeartion
2 years after opeartion
nutritional status
Time Frame: 2 years after opeartion
2 years after opeartion
mortality
Time Frame: 3 months after operation
3 months after operation
Incidence of pancreatic fistula gradeB/C defined by ISGPF classification
Time Frame: 3 months after oepration
3 months after oepration
Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma
Time Frame: 3 months after oepration
3 months after oepration
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
Time Frame: 3 months after operation
3 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wakayama Medical University

Collaborators

Osaka University
Kyoto Prefectural University of Medicine
Nara Medical University
Kansai Rosai Hospital
Hyogo College of Medicine

Investigators

  • Principal Investigator: Manabu Kawai, MD, Wakayama Medical University, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNOW study-1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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