Reduced Pancreatic Fistula Rate Following Pancreaticoduodenectomy: Trial on Pancreaticogastrostomy Versus Pancreaticojejunostomy

Summary

The incidence of complications after pancreaticoduodenectomy (PD) is around 50 %. The postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula (POPF), which determines postoperative mortality, length of hospital stay and costs. The incidence of POPF after PD is dependent of its definition, and is reported in up to 20% of patients.

There is disagreement on whether to perform a pancreaticojejunostomy (PJ) or a pancreaticogastrostomy (PG) after PD. The aim of the current randomized controlled trial is to study whether PG significantly reduces the rate of POPF following PD for pancreatic or peri-ampullary tumours. Secondary endpoints are the reduction of overall postoperative complication rate and their severity.

Conditions

• Tumors

Interventions

PROCEDURE

Pancreaticojejunostomy

Pancreaticojejunostomy (PJ) reconstruction/anastomosis

PROCEDURE

Pancreaticogastrostomy

Pancreaticogastrostomy (PG) reconstruction/anastomosis

Sponsors & Collaborators

• Erasme ULB, Brussels

  collaborator UNKNOWN

• Jolimont, Brussels

  collaborator UNKNOWN

• St.Lucas, Brugge

  collaborator UNKNOWN

• General Hospital Groeninge

  collaborator OTHER

• Université Catholique de Louvain

  collaborator OTHER

• Clinique Saint Joseph, Liège

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Jan Palfijn, Antwerp

  collaborator UNKNOWN

• AZ Sint-Lucas Brugge

  collaborator OTHER

• Monica, Deurne

  collaborator UNKNOWN

• Baki Topal

  lead OTHER

Principal Investigators

• Baki Topal, MD, PhD · Universitaire Ziekenhuizen KU Leuven

• Claude Bertrand, MD · Hospital Jolimont, Brussels

• Jean Closset, MD, PhD · Hospital Erasme (ULB), Brussels

• Henk Thieren, MD · AZ. St.Lucas, Brugge

• Franky Vansteenkiste, MD · General Hospital Groeninge

• Jean-Francois Gigot, MD, PhD · Université Catholique de Louvain

• Joseph Weerts, MD · St.Joseph Hospital, Liège

• Geert Roeyen, MD · University Hospital Antwerp, Antwerp

• Marc Janssens, MD · J.Palfijn Hospital, Antwerp

• Tom Feryn, MD · St.Jan Hospital, Brugge

• Steven Pauli, MD · Monica Hospital, Deurne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2012-08-31

Completion

2012-09-30

Countries

• Belgium

Study Locations