CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 168 enrolled
Drug / intervention
closed suction drainage of pancreatic duct +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00679952
NCT00679952Phase 3Completed

Randomised Prospective Study of Clinical Outcomes After Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy After Pancreatoduodenectomy

Seoul National University Hospital·interventional·Posted May 19, 2008·Updated May 19, 2014

In Brief

A Phase 3 clinical trial evaluating closed suction drainage of pancreatic duct and natural drainage of pancreatic duct for Pancreatic Fistula. Completed, enrolled 168 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2008
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.1 years ago

Interventions

closed suction drainage of pancreatic ductprocedure

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.

natural drainage of pancreatic ductprocedure

Natural drainage group