Biliary Externalization After Pancreaticoduodenectomy

• Sponsor: Universidad de Extremadura (Other)
• Overall Status: Completed
• CT.gov ID: NCT04654299
• Collaborator: (none)
• Enrollment: 128
• Actual Duration (Months): 50.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications	Procedure: External biliary stent

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 128 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Mar 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
standard PD (ST-PD) Pancreacoduodenectomy with pancreatic-enteric reconstruction and standard hepaticojejunostomy
PD with external biliary stent(PD-BS) Pancreacoduodenectomy with pancreatic-enteric reconstruction and hepaticojejunostomy with external biliary stent for externalization of bile fluid	Procedure: 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

Outcome Measures

Primary Outcome Measures

1. Postoperative complications [90 days]

   Any postoperative complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universidad de Extremadura

Investigators

• Study Director: Gerardo Blanco-Fernández, MD, PhD, Universidad de Extremadura

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerardo Blanco-Fernández, Chief of Department, Universidad de Extremadura
• ClinicalTrials.gov Identifier: NCT04654299
• Other Study ID Numbers: 20201129
• First Posted: Dec 4, 2020
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gerardo Blanco-Fernández, Chief of Department, Universidad de Extremadura: Pancreaticoduodenectomy; Pancreatic postoperative fistula
• Additional relevant MeSH terms: Postoperative Complications

Study Results

No Results Posted as of Jun 21, 2022