NCT05567003: PEBBL

Percutaneous Endoluminal Benign Biliary Laser

Terminated Phase 4 Last updated 30 April 2025

What this trial tests

Phase 4 trial testing Percutaneous transhepatic cholangioscopic (PTCS) laser incision in Benign Biliary Strictures With Current or Prior Biliary Obstruction in 5 participants. Terminated before completion.

Timeline

1 November 2022

Primary endpoint
5 January 2024

5 February 2024

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 November 2022
Primary completion	5 January 2024
Estimated completion	5 February 2024
Sites	1 location across United States

Drugs / interventions tested

• Percutaneous transhepatic cholangioscopic (PTCS) laser incision

Conditions studied

• Benign Biliary Strictures With Current or Prior Biliary Obstruction — all drugs for Benign Biliary Strictures With Current or Prior Biliary Obstruction →

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Benign Biliary Strictures With Current or Prior Biliary Obstruction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Twelve-month Results From the Percutaneous Endoscopic Benign Biliary Laser Stricturotomy Study: A Prospective Single-Arm Pilot Trial Evaluating Safety and Efficacy.
   Roberts DG, Ramakrishnan A, Joglekar A, Sayre J, et al · · 2026 · PMID 41140760 · DOI 10.1016/j.gastha.2025.100770