Biliary Externalization After Pancreaticoduodenectomy

Postoperative Complications Clinical Trial

Official title:

Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654299
• Other study ID #: 20201129
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: March 31, 2018

Study information

• Verified date: June 2022
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 31, 2018
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Extremadura

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Any postoperative complications	90 days