Biliary Externalization After Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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standard PD (ST-PD)

Pancreacoduodenectomy with pancreatic-enteric reconstruction and standard hepaticojejunostomy

No interventions assigned to this group

PD with external biliary stent(PD-BS)

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

External biliary stent

Intervention Type PROCEDURE

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

Interventions

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External 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No