Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy

Phase 1

• Conditions: Pancreatic Cancer; Pancreatic Anastomotic Leak
• Interventions: Procedure: Pancreatico gastro anastomosis; Procedure: Pancreaticojejuno anastomosis

• Registration Number: NCT01324856
• Lead Sponsor: University of Belgrade

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Study Start: 2011-04
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-11
• Primary Completion: 2013-04
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• Age bellow 18 and under 80
• prevous pancreatic surgery
• pregnancy
• Psychosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pancreaticogastro anastomosis	Pancreatico gastro anastomosis	-
Pancreaticojejuno anastomosis	Pancreaticojejuno anastomosis	-

Primary Outcome Measures

Name	Time	Method
abdominal complications	2 years	Abdominal complications comprises: Pancreatic fistula, acute fluid collection, acute pancreatitis, billiay fistula, gastric fistula, enteral distula, hemorrhage and delayed gastric emptying

Trial Locations

Locations (4)

Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade; 🇷🇸 Belgrade, Serbia

Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia

Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia

Surgical Department, Military-Medical Academy; 🇷🇸 Belgrade, Serbia