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Percutaneous Endoluminal Benign Biliary Laser

NCT05567003 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-04-30

No results posted yet for this study

Summary

This study is being done to evaluate the safety and efficacy of Percutaneous transhepatic cholangioscopic (PTCS) laser incision as an ancillary therapy to traditional approaches such as balloon dilation and large drain placement for Benign Biliary Strictures (BBS).

Narrowing or blockage of the bile ducts (biliary stricture) is a difficult to treat medical condition that leads to life-threatening complications. Treatment usually involves multiple procedures or surgeries spanned over months or years, and in many cases, leads to the need for a life-long tube that drains bile fluid outside of the body and into a bag. PTCS laser incision is a promising new treatment for bile duct strictures. The procedure is performed by an Interventional Radiologist who uses a tiny camera (endoscope) and a laser through a small hole in the skin to open up the blocked or narrowed duct. This allows bile to flow freely where it is supposed to go (without a tube) so that it does not backup up and cause life-threatening problems. Based on early experience from patients who have had this procedure done, it appears to be safe and effective, and may lead to needing fewer procedures over time, with the possibility of living without a tube or drain. The main goal of this study is to confirm the safety and efficacy of PTCS laser incision in a series of patients with benign biliary strictures who would otherwise receive standard treatment with long-term biliary tube drainage.

Conditions

  • Benign Biliary Strictures With Current or Prior Biliary Obstruction

Interventions

PROCEDURE

Percutaneous transhepatic cholangioscopic (PTCS) laser incision

Infrared percutaneous transhepatic cholangioscopic guided holmium laser incision for treatment of benign biliary strictures.

Sponsors & Collaborators

Principal Investigators

  • Ravi N Srinivasa, MD · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-01-05
Completion
2024-02-05

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT05567003 on ClinicalTrials.gov