Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Erasme ULB, Brussels
Jolimont, Brussels
St.Lucas, Brugge
General Hospital Groeninge
Universite Catholique Louvain (UCL), Brussels
St.Joseph, Liège
University Hospital, Antwerp
Jan Palfijn, Antwerp
St.Jan, Brugge
Monica, Deurne
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00830778
First received: January 27, 2009
Last updated: September 11, 2012
Last verified: September 2012
  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 University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Reduction of clinical postoperative pancreatic fistula (POPF) rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of overall postoperative pancreatic fistula rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Reduction of the severity of postoperative complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Universite Catholique Louvain (UCL), Brussels
St.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 Universite Catholique Louvain (UCL), Brussels
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

No publications provided by University Hospital, Gasthuisberg

Additional 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
Study First Received: January 27, 2009
Last Updated: September 11, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by 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:
Pancreatic Fistula
Digestive System Diseases
Digestive System Fistula
Fistula
Pancreatic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014