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Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

NCT04805450 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1075

Last updated 2023-03-21

No results posted yet for this study

Summary

Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered \[1\]. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents \[2-5\].

The aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.

Conditions

  • Malignant Bile Duct Obstruction

Interventions

PROCEDURE

ES before fully covered SEMS placement

PROCEDURE

no ES before fully covered SEMS placement

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04805450 on ClinicalTrials.gov