CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
isolated roux loop +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/NCT03671031
NCT03671031N/ACompleted

Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Inonu University·observational·Posted Sep 14, 2018·Updated Sep 25, 2018

In Brief

An observational study evaluating isolated roux loop and single loop for Pancreatic Fistula. Completed, enrolled 109 participants across 1 site.

Detailed Summary

Pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. Although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50% (1,2). Pancreatic anastomotic leaks and fistulas continue to be the main source of morbidity and mortality after pancreaticoduodenectomy. Although there are several recommended techniques to reduce the rate of pancreatic fistulas, optimal pancreatic reconstruction technique is still controversial (3-5). One of the recommended techniques for pancreatic reconstruction is isolated Roux loop pancreaticojejunostomy (6). With this method, as pancreatic anastomosis is kept away from biliary and gastric anastomoses, activation of the pancreatic enzyme precursors is blocked and in this way a reduction in the rate and severity of pancreatic fistula and also in the overall morbidity and mortality can be achieved (6-8). In this study, it is aimed to examine if isolated Roux loop pancreaticojejunostomy is superior to conventional pancreaticojejunostomy on postoperative outcomes.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartJan 1, 2009
Primary CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 7.8 years ago

Interventions

isolated roux loopprocedure

Isolated roux loop reconstruction following pancreaticoduodenectomy

single loopprocedure

Conventional single loop reconstruction following pancreaticoduodenectomy