Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy
Conditions
Pancreatic Cancer - Pancreatic Anastomotic Leak
Conditions: official terms
Anastomotic Leak - Pancreatic Neoplasms
Conditions: Keywords
pancreatic cancer, periampulary cancer, pancreaticogastro vs pancreaticojejuno anastomosis
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pancreatico gastro anastomosis Type: Procedure
Name: Pancreaticojejuno anastomosis Type: Procedure
Overall Status
Not yet recruiting
Summary
Pancreaticoduodenectomy is the standards surgical procedure for various malignant and benign disease of the pancreas and periampullariy region. During the recent years, mortality rate of pancreaticoduodenectomy has decreased to 5% in specialized centers. Although, this procedure still carries considerable morbidity up to 40%, depending of definition of complications. Pancreatic fistula remains a common complication and the main cause of other morbidities and mortality. Pancreaticojejunal (PJ) anastomosis is the most often used method of reconstruction after pancreaticoduodenectomy. Several technique modifications such as placement of the stents, reinforcement of anasomosis with fibrin glue, pancreatic duct occlusion and pancreaticogastrostomy (PG) type of anastomosis was used in order to decrease pancreatic fistula rate. Since, some retrospective studies showed better results with some technique, several meta-analyses did not show any advantage of those various modifications. It was shown that the higher risk of pancreatic fistula was noticed in patients with soft residual pancreas and small diameter of pancreatic duct. There is only one randomized study in the literature dealing with this problem. This study did not reveal any significant differences between PG and PJ in patients with soft pancreas and small duct. In order to investigate once more this important issue, the researchers conducted randomized multicenter controlled trial.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients undergone cephalic duodenopanceatectomy

- soft pancreas

- small diameter of the pancreatic remnant

Exclusion Criteria:

- Age bellow 18 and under 80

- prevous pancreatic surgery

- pregnancy

- Psychosis
Locations
Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade
Belgrade, Serbia
Status: Not yet recruiting
Contact: Dejan Radenkovic, MD, PhD - +381 63 204 205 - dejanr@sbb.rs
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
Belgrade, Serbia
Status:
Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
Belgrade, Serbia
Status:
Surgical Department, Military-Medical Academy
Belgrade, Serbia
Status:
Start Date
April 2011
Completion Date
September 2013
Sponsors
University of Belgrade
Source
University of Belgrade
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page