Biliary Externalization After Pancreaticoduodenectomy

Universidad de Extremadura

Status: Completed

Conditions: Postoperative Complications

Treatments: Procedure: External biliary stent

Study type: Observational

Funder types: Other

Identifiers

NCT04654299

20201129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent
• Patient age > 18 years old;
• Elective pancreaticoduodenectomy performed for primary pancreatic disease.

Exclusion criteria

• Pancreaticoduodenectomy with multivisceral resection (organ other than duodenum, pancreas, gallbladder, and bile duct);
• Patients with peritoneal or liver metastases found during surgery.

Trial design

128 participants in 2 patient groups

standard PD (ST-PD)

Description:

Pancreacoduodenectomy with pancreatic-enteric reconstruction and standard hepaticojejunostomy

PD with external biliary stent(PD-BS)

Description:

Pancreacoduodenectomy with pancreatic-enteric reconstruction and hepaticojejunostomy with external biliary stent for externalization of bile fluid

Treatment:

Procedure: External biliary stent