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Procedure

Biliary Laser Therapy for Benign Biliary Strictures (PEBBL Trial)

Phase 4

Recruiting

Led By Ravi N Srinivasa, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

PEBBL Trial Summary

This trial is studying a new treatment for bile duct strictures that appears to be safe and effective.

Who is the study for?

This trial is for adults over 18 with benign biliary strictures, showing signs of bile duct blockage. It's not for those who've had a liver transplant in the last 90 days, have cancerous strictures, severe infections like cholangitis or sepsis, multiple narrowed duct segments from primary sclerosing cholangitis, immediate decompression needs, or a life expectancy under three years.Check my eligibility

What is being tested?

The study tests PTCS laser incision as an additional treatment to traditional methods for benign biliary strictures. The procedure involves using a camera and laser through the skin to open up blocked bile ducts potentially reducing the need for long-term external drainage tubes.See study design

What are the potential side effects?

While early patient experiences suggest safety and effectiveness of PTCS laser incision, potential side effects may include pain at the incision site, infection risk due to invasive nature of procedure, bleeding complications or damage to surrounding tissues.

PEBBL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of Procedure

Incidence of Post Procedure Adverse Events

Secondary outcome measures

12-Month Cumulative Complications

Primary Bile Duct Patency

Tube-Free Survival

PEBBL Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with benign biliary stricturesExperimental Treatment1 Intervention

Patients with benign biliary strictures with current or prior biliary obstruction, who would otherwise receive standard treatment with long-term biliary tube drainage.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,228 Total Patients Enrolled

Boston Scientific CorporationIndustry Sponsor

720 Previous Clinical Trials

932,982 Total Patients Enrolled

Ravi N Srinivasa, MDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

Percutaneous transhepatic cholangioscopic (PTCS) laser incision (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05567003 — Phase 4

Benign Biliary Strictures Research Study Groups: Patients with benign biliary strictures

Benign Biliary Strictures Clinical Trial 2023: Percutaneous transhepatic cholangioscopic (PTCS) laser incision Highlights & Side Effects. Trial Name: NCT05567003 — Phase 4

Percutaneous transhepatic cholangioscopic (PTCS) laser incision (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05567003 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is participation in this trial widespread?

"Affirmative. According to clinicaltrials.gov, this research endeavour is recruiting participants as of October 10th 2022 and was recently updated on the 7th day of that month. The investigation requires 40 volunteers from a single medical institution."

Answered by AI

What main goals is this research attempting to achieve?

"This clinical trial seeks to assess the feasibility of a procedure over 24 months, with secondary outcomes including 12-month cumulative complications from laser treatment or recurrent biliary disease; tube-free survival evaluated as cumulative time survived without a biliary device during the study period and primary bile duct patency evaluated as mean time to first stricture recurrence."

Answered by AI

Has this treatment received the stamp of approval from the FDA?

"As this is a Phase 4 trial, the treatment's safety rating has been assessed as 3 on our team at Power's scale. This signifies that it has already received approval for use."

Answered by AI

Is this experiment still open to participants?

"Affirmative. Clinicaltrials.gov data verify that this research, which was initially listed on October 10th 2022, is currently recruiting. Approximately 40 patients must be recruited from 1 medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Percutaneous Endoluminal Benign Biliary Laser

Ravi N. Srinivasa, MD 2022. "Percutaneous Endoluminal Benign Biliary Laser". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05567003.