Clinical Trials Directory

Trials / Completed

CompletedNCT01384617

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
136 (estimated)
Sponsor
Wakayama Medical University · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

Summary

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.

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 .

Conditions

Interventions

TypeNameDescription
PROCEDUREStapling closure of the pancreatic stumpEchelon 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.
PROCEDURERoux-en-Y anastomosis of the pancreatic stumpend-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.

Timeline

Start date
2011-06-01
Primary completion
2014-06-01
Completion
2016-06-01
First posted
2011-06-29
Last updated
2016-07-21

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT01384617. Inclusion in this directory is not an endorsement.