CompletedPhase 3

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

Belgium336 participantsStarted 2009-06

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Reduction of clinical postoperative pancreatic fistula (POPF) rate

Timeframe: 3 years

Trial details

NCT IDNCT00830778

SponsorBaki Topal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08