Clinical trial · Interventional
Reduced Pancreatic Fistula Rate Following Pancreaticoduodenectomy: Trial on Pancreaticogastrostomy Versus Pancreaticojejunostomy
Reduced Postoperative Pancreatic Fistula Rate Following Pancreaticoduodenectomy; Multicentric Randomized Controlled Trial on Pancreaticogastrostomy vs. Pancreaticojejunostomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreaticogastrostomy | Procedure | — | UNRESOLVED |
| Pancreaticojejunostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PG anastomosis
- description
- Pancreaticogastrostomy (PG) reconstruction/anastomosis after pancreaticoduodenectomy (PD)
- interventionNames
- Procedure: Pancreaticogastrostomy
- type
- ACTIVE_COMPARATOR
- label
- PJ anastomosis
- description
- Pancreaticojejunostomy (PJ) reconstruction/anastomosis after pancreaticoduodenectomy (PD)
- interventionNames
- Procedure: Pancreaticojejunostomy
Primary outcomes (1)
- measure
- Reduction of clinical postoperative pancreatic fistula (POPF) rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDTopal 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
- DERIVEDBertrand 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