Biliary Externalization After Pancreaticoduodenectomy

NCT04654299 | Completed

• 1 other identifier: 20201129
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Complications

Keywords

Pancreaticoduodenectomy; Pancreatic postoperative fistula

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Any postoperative complications

  90 days

Study Arms (2)

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

Interventions

External biliary stent 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

PD with external biliary stent(PD-BS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergo elective pancreaticoduodenectomy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Extremadura: lead

Related Publications (1)

• Blanco-Fernandez G, Jaen-Torrejimeno I, De-Armas-Conde N, Rojas-Holguin A, Naharro JS, Castillo-Tunon JM, Lopez-Guerra D. Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy. J Gastrointest Surg. 2021 Nov;25(11):2881-2888. doi: 10.1007/s11605-021-04983-6. Epub 2021 Mar 25.

  PMID: 33768426 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerardo Blanco-Fernández, MD, PhD

  Universidad de Extremadura

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 4, 2020
• Study Start: January 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2018
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share