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Biliary Externalization After Pancreaticoduodenectomy

Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04654299
Enrollment
128
Registered
2020-12-04
Start date
2014-01-01
Completion date
2018-03-31
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

Pancreaticoduodenectomy, Pancreatic postoperative fistula

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.

Interventions

PROCEDUREExternal biliary stent

The biliary stent consisted of a multi-perforated, natural rubber tube, measuring 3.5 mm in diameter, that we placed transanastomotically, with exteriorization sited at 20 cm utilizing the Witzel jejunostomy approach

Sponsors

Universidad de Extremadura
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative complications90 daysAny postoperative complications

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026