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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830778
First Posted: January 28, 2009
Last Update Posted: September 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Erasme ULB, Brussels
Jolimont, Brussels
St.Lucas, Brugge
General Hospital Groeninge
Université Catholique de Louvain
Clinique Saint Joseph, Liège
University Hospital, Antwerp
Jan Palfijn, Antwerp
St.Jan, Brugge
Monica, Deurne
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg
  Purpose

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.


Condition Intervention Phase
Tumors Procedure: Pancreaticojejunostomy Procedure: Pancreaticogastrostomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Reduced Postoperative Pancreatic Fistula Rate Following Pancreaticoduodenectomy; Multicentric Randomized Controlled Trial on Pancreaticogastrostomy vs. Pancreaticojejunostomy

Resource links provided by NLM:


Further study details as provided by Baki Topal, University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Reduction of clinical postoperative pancreatic fistula (POPF) rate [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Reduction of overall postoperative pancreatic fistula rate [ Time Frame: 3 years ]
  • Reduction of the severity of postoperative complications [ Time Frame: 3 years ]

Estimated Enrollment: 336
Study Start Date: June 2009
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PG anastomosis
Pancreaticogastrostomy (PG) reconstruction/anastomosis after pancreaticoduodenectomy (PD)
Procedure: Pancreaticogastrostomy
Pancreaticogastrostomy (PG) reconstruction/anastomosis
Active Comparator: PJ anastomosis
Pancreaticojejunostomy (PJ) reconstruction/anastomosis after pancreaticoduodenectomy (PD)
Procedure: Pancreaticojejunostomy
Pancreaticojejunostomy (PJ) reconstruction/anastomosis

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients, male or female, who undergo PD for a pancreatic or peri-ampullary tumor
  • Age between 18 to 85 years
  • Patients with and without pre-operative biliary drainage (for obstructive jaundice)
  • Concomitant surgical procedures such as simultaneous colonic resection etc.
  • Reconstruction of the portal vein or superior mesenteric vein

Exclusion Criteria:

  • Age < 18years
  • Pregnancy
  • Pre-operative radiotherapy
  • PD for IPMT
  • PD for chronic pancreatitis
  • PD for pancreatic trauma
  • PD for post-ERCP complications
  • Any arterial reconstruction at the time of surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830778


Locations
Belgium
University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Baki Topal
Erasme ULB, Brussels
Jolimont, Brussels
St.Lucas, Brugge
General Hospital Groeninge
Université Catholique de Louvain
Clinique Saint Joseph, Liège
University Hospital, Antwerp
Jan Palfijn, Antwerp
St.Jan, Brugge
Monica, Deurne
Investigators
Study Director: Baki Topal, MD, PhD Universitaire Ziekenhuizen Leuven
Principal Investigator: Claude Bertrand, MD Hospital Jolimont, Brussels
Principal Investigator: Jean Closset, MD, PhD Hospital Erasme (ULB), Brussels
Principal Investigator: Henk Thieren, MD AZ. St.Lucas, Brugge
Principal Investigator: Franky Vansteenkiste, MD General Hospital Groeninge
Principal Investigator: Jean-Francois Gigot, MD, PhD Université Catholique de Louvain
Principal Investigator: Joseph Weerts, MD St.Joseph Hospital, Liège
Principal Investigator: Geert Roeyen, MD University Hospital Antwerp, Antwerp
Principal Investigator: Marc Janssens, MD J.Palfijn Hospital, Antwerp
Principal Investigator: Tom Feryn, MD St.Jan Hospital, Brugge
Principal Investigator: Steven Pauli, MD Monica Hospital, Deurne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baki Topal, MD, PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00830778     History of Changes
Other Study ID Numbers: S51480
First Submitted: January 27, 2009
First Posted: January 28, 2009
Last Update Posted: September 12, 2012
Last Verified: September 2012

Keywords provided by Baki Topal, University Hospital, Gasthuisberg:
pancreas
surgery
cancer
pancreaticoduodenectomy (PD)
peri-ampullary tumours (ampulla, duodenum, distal bile duct, and miscellaneous tumours)
pancreatic tumors
peri-ampullary tumors

Additional relevant MeSH terms:
Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases