CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Duct to mucosa PJ group +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/NCT02142517
NCT02142517N/ACompleted

Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy: A Prospective Randomized Study

Mansoura University·interventional·Posted May 20, 2014·Updated May 20, 2014

In Brief

A clinical study evaluating Duct to mucosa PJ group and Invagination PJ group for Pancreatic Anastomotic Leak. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Postoperative pancreatic fistula (POPF) remains a challenge even at specialized centers, and also affect significantly the surgical outcomes . The incidence of POPF after pancreaticoduodenectomy among different studies, ranging from 5 to 30%.Morbidity and mortality after pancreaticoduodenectomy are usually related to surgical management of the pancreatic stump. The safe pancreatic reconstruction after pancreaticoduodenectomy continues to be a challenge at high volume centers. The variety of reconstruction is a reflection of the lack of ideal one.Duct to mucosa and invagination are two classic PJ techniques. Many studies compared both techniques, but their surgical outcomes still unclear.The aim of the study was to assess the effectiveness and surgical outcomes of both techniques of PJ after pancreaticoduodenectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 20, 2014
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.1 years ago

Interventions

Duct to mucosa PJ groupprocedure

Duct to mucosa PJ was performed by a two layer end to side PJ. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic duct diameter. The inner layer duct to mucosa was performed in eight to twelve stitches with 5/0 prolene. A pancreatic duct stent was inserted during anastomosis to allow easy and accurate suture placement, ensure adequate pancreatic duct exposure, and protect the opposite wall from being inadvertently held by needles then it was removed at the end of anastomosis.

Invagination PJ groupprocedure

Invagination PJ was performed as an end to side. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic stump diameter. The inner layer was performed with 5/0 prolene between pancreatic parenchyma and mucosa. The duct was taken posteriorly and anteriorly to jejunal mucosa. A pancreatic duct stent was inserted during anastomosis and removed at the end of taking the stitches. Reconstruction was completed by end to side hepaticojejunostomy (retrocolic) and gastrojejunostomy (GJ) (antecolic) end to side manually.