Biliary Externalization After Pancreaticoduodenectomy
- Conditions
- Postoperative Complications
- Interventions
- Procedure: External biliary stent
- Registration Number
- NCT04654299
- Lead Sponsor
- Universidad de Extremadura
- Brief Summary
Postoperative pancreatic fistula(POPF) is the most common complication of pancreaticoduodenectomy (PD). Sometimes POPF is associated with biliary fistula(BF), or "mixed" fistula. The purpose of this study is to assess whether the severity of the fistulae, when present, is decreased with an external biliary stent in place.
- Detailed Description
n this single-center study we analyze patients who underwent elective PD from January_2014 to December_2017. Patients are divided into two groups: standard PD (ST-PD)vs PD with external biliary stent(PD-BS). Demographic, preoperative, intraoperative, and postoperative variables will be analyze, including complications according to the Clavien-Dindo classification, and those specific to pancreatic surgeries, and mortality rates within 90 days of operation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- Provision of informed consent
- Patient age > 18 years old;
- Elective pancreaticoduodenectomy performed for primary pancreatic disease.
- Pancreaticoduodenectomy with multivisceral resection (organ other than duodenum, pancreas, gallbladder, and bile duct);
- Patients with peritoneal or liver metastases found during surgery.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PD with external biliary stent(PD-BS) External biliary stent Pancreacoduodenectomy with pancreatic-enteric reconstruction and hepaticojejunostomy with external biliary stent for externalization of bile fluid
- Primary Outcome Measures
Name Time Method Postoperative complications 90 days Any postoperative complications
- Secondary Outcome Measures
Name Time Method