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Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy

NCT00679952 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2014-05-19

Study results available
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Summary

Pancreaticojejunal anastomosis leakage is a major complication after pancreatoduodenectomy and various technical methods have been examined to improve the situation.However, none of methods have been successful at improving results according to the findings of prospective randomized studies. We propose that active drainage of pancreatic juice using suction drainage might maximize the advantage of a stent and finally reduce pancreaticojejunal anastomosis leakage.

Conditions

  • Pancreatic Fistula

Interventions

PROCEDURE

closed suction drainage of pancreatic duct

A Fr 5-8 silastic polyethylene pediatric feeding tube with multiple side-holes is inserted 2 cm into the pancreatic duct. The catheter exited via a small enterotomy in the jejunal loop of the distal portion of the hepaticojejunostomy. Totally externalized pancreatic stents were connected to the aspiration bag of a Jackson-Pratt drain to generate negative pressure or to a bile bag for natural drainage.

PROCEDURE

natural drainage of pancreatic duct

Natural drainage group

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Sun-Whe Kim, MD., PhD. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-03-31
Completion
2010-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00679952 on ClinicalTrials.gov