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

NCT02142517 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-05-20

No results posted yet for this study

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.

Conditions

  • Pancreatic Anastomotic Leak

Interventions

PROCEDURE

Duct to mucosa PJ group

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.

PROCEDURE

Invagination PJ group

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ayman El Nakeeb, MD · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Egypt

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 NCT02142517 on ClinicalTrials.gov