Status:
COMPLETED
Reduced Pancreatic Fistula Rate Following Pancreaticoduodenectomy: Trial on Pancreaticogastrostomy Versus Pancreaticojejunostomy
Lead Sponsor:
Baki Topal
Collaborating Sponsors:
Erasme ULB, Brussels
Jolimont, Brussels
Conditions:
Tumors
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 determin...
Detailed Description
Therapeutic intervention * Surgeons who have performed a minimum of five (5) PG and PJ procedures can include patients in this randomized trial. * Any dissection device or technique is allowed. * Pan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT00830778
Start Date
June 1 2009
End Date
September 1 2012
Last Update
September 12 2012
Active Locations (1)
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1
University Hospital Gasthuisberg
Leuven, Belgium, 3000