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

NCT00830778 | Completed Phase 3 DMC

• 1 other identifier: S51480
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pancreas; surgery; cancer; pancreaticoduodenectomy (PD); peri-ampullary tumours (ampulla, duodenum, distal bile duct, and miscellaneous tumours); pancreatic tumors; peri-ampullary tumors

Outcome Measures

Primary Outcomes (1)

• Reduction of clinical postoperative pancreatic fistula (POPF) rate

  3 years

Secondary Outcomes (2)

• Reduction of overall postoperative pancreatic fistula rate

  3 years

• Reduction of the severity of postoperative complications

  3 years

Study Arms (2)

PG anastomosis

EXPERIMENTAL

Pancreaticogastrostomy (PG) reconstruction/anastomosis after pancreaticoduodenectomy (PD)

Procedure: Pancreaticogastrostomy

PJ anastomosis

ACTIVE COMPARATOR

Pancreaticojejunostomy (PJ) reconstruction/anastomosis after pancreaticoduodenectomy (PD)

Procedure: Pancreaticojejunostomy

Interventions

Pancreaticojejunostomy PROCEDURE

Pancreaticojejunostomy (PJ) reconstruction/anastomosis

PJ anastomosis

Pancreaticogastrostomy PROCEDURE

Pancreaticogastrostomy (PG) reconstruction/anastomosis

PG anastomosis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baki Topal: lead
• Erasme ULB, Brussels: collaborator
• Jolimont, Brussels: collaborator
• St.Lucas, Brugge: collaborator
• General Hospital Groeninge: collaborator
• Université Catholique de Louvain: collaborator
• Clinique Saint Joseph, Liège: collaborator
• University Hospital, Antwerp: collaborator
• Jan Palfijn, Antwerp: collaborator
• AZ Sint-Lucas Brugge: collaborator
• Monica, Deurne: collaborator

Study Sites (1)

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (2)

• Topal B, Fieuws S, Aerts R, Weerts J, Feryn T, Roeyen G, Bertrand C, Hubert C, Janssens M, Closset J; Belgian Section of Hepatobiliary and Pancreatic Surgery. Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy for pancreatic or periampullary tumours: a multicentre randomised trial. Lancet Oncol. 2013 Jun;14(7):655-62. doi: 10.1016/S1470-2045(13)70126-8. Epub 2013 May 2.

  PMID: 23643139 DERIVED

• Bertrand C, Squifflet JP, Gys T, Berrevoet F, Jehaes C, Lerut T, Malaise J, Topal B. The Society for Internet-based Scientific Studies: a new platform to promote multicentric studies in the Royal Belgian Society for Surgery. Acta Chir Belg. 2010 Jan-Feb;110(1):3-5. doi: 10.1080/00015458.2010.11680554. No abstract available.

  PMID: 20306901 DERIVED

MeSH Terms

Conditions

Neoplasms; Pancreatic Neoplasms

Interventions

Pancreaticojejunostomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Baki Topal, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 12, 2012

Record last verified: 2012-09

Locations

BE (1)