Pancreaticogastrostomy Versus Pancreaticojejunostomy In Reconstruction After Cephalic Duodenopancreatectomy

Study Overview

Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy

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.

N/A

Pancreatic Cancer
Pancreatic Anastomotic Leak

PROCEDURE: Pancreatico gastro anastomosis
PROCEDURE: Pancreaticojejuno anastomosis

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Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-03-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-04-08
First Submitted that Met QC Criteria 2011-03-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-04-11
First Posted (ESTIMATED) 2011-03-29	Results First Posted N/A	Last Verified 2011-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Pancreaticogastro anastomosis	PROCEDURE: Pancreatico gastro anastomosis After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico gasto teremino-lateral anastomosis will be performed. The anastomosis will be done with posterior wall of the stomach. Pancreas will be mobilized at least 5 cm, two tobaco stiches
ACTIVE_COMPARATOR: Pancreaticojejuno anastomosis	PROCEDURE: Pancreaticojejuno anastomosis After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico jejuno termino lateral duct to mucosa anastomosis will be performed. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Pancreaticogastro anastomosis

PROCEDURE: Pancreatico gastro anastomosis

After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico gasto teremino-lateral anastomosis will be performed. The anastomosis will be done with posterior wall of the stomach. Pancreas will be mobilized at least 5 cm, two tobaco stiches

ACTIVE_COMPARATOR: Pancreaticojejuno anastomosis

PROCEDURE: Pancreaticojejuno anastomosis

After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico jejuno termino lateral duct to mucosa anastomosis will be performed. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.

Primary Outcome Measures	Measure Description	Time Frame
abdominal complications	Abdominal complications comprises: Pancreatic fistula, acute fluid collection, acute pancreatitis, billiay fistula, gastric fistula, enteral distula, hemorrhage and delayed gastric emptying	2 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dejan Radenkovic, MD, PhD

Phone Number: +381 63 204 205

Email: dejanr@sbb.rs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients undergone cephalic duodenopanceatectomy
soft pancreas
small diameter of the pancreatic remnant

Age bellow 18 and under 80
prevous pancreatic surgery
pregnancy
Psychosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Dejan Radenkovic, MD,PhD, Clinic for Digestive disease, Clinical center of Serbia and School of Medicine University of Belgrade

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, Buchler MW. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007 Feb;193(2):171-83. doi: 10.1016/j.amjsurg.2006.10.010.
Bassi C, Falconi M, Molinari E, Salvia R, Butturini G, Sartori N, Mantovani W, Pederzoli P. Reconstruction by pancreaticojejunostomy versus pancreaticogastrostomy following pancreatectomy: results of a comparative study. Ann Surg. 2005 Dec;242(6):767-71, discussion 771-3. doi: 10.1097/01.sla.0000189124.47589.6d.
Yeo CJ, Cameron JL, Maher MM, Sauter PK, Zahurak ML, Talamini MA, Lillemoe KD, Pitt HA. A prospective randomized trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy. Ann Surg. 1995 Oct;222(4):580-8; discussion 588-92. doi: 10.1097/00000658-199510000-00014.

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Resources

PatientS

Caregivers

Clinical Trial Record