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Benign Biliary Strictures With Current or Prior Biliary ObstructionPhase 4PEBBLNCT05567003

Percutaneous Endoluminal Benign Biliary Laser

A Phase 4 study testing Percutaneous transhepatic cholangioscopic (PTCS) laser incision in people with Benign Biliary Strictures With Current or Prior Biliary Obstruction, run by University of California, Los Angeles at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Percutaneous transhepatic cholangioscopic (PTCS) laser incision
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
1 Nov 2022to 5 Feb 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of Benign Biliary Strictures (BBS)
  • Clinical and/or laboratory evidence of biliary obstruction (current or prior)
  • Age 18 years or older at the time of intervention

Who cannot join

  • Patients with a diagnosis of malignant biliary stricture at the time of enrollment
  • Patients who are subsequently diagnosed with malignant biliary stricture during the study period
  • Liver transplantation within the last 90 days
  • Active cholangitis or sepsis
  • Emergent need for biliary decompression
  • Patients with a diagnosis of primary sclerosing cholangitis with presence of 3 or more strictured segments
  • Patients with a life-expectancy of less than 36 months

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California Los Angeles

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Percutaneous Endoscopic Laser Incision for Benign Biliary Strictures: Prospective Evaluation of Safety and Efficacy

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.

Read the detailed description

PTCS-guided holmium laser incision is a promising new adjuvant treatment for benign biliary strictures. Real-time monitoring under direct endoscopic visualization provides an invaluable opportunity for Interventional Radiologists to safely perform targeted diagnosis and treatment within the biliary system. Despite limited literature on the subject, there are several potential advantages of bringing cholangioscopic laser incision to the Interventional Radiology (IR) suite.

First, management of biliary strictures and their sequelae is commonplace in daily IR practice. With increasing sophistication of modern therapeutics including ablation, lithotripter, stent and retrieval devices, there is increasing risk to using fluoroscopy alone to perform complex interventions in a three-dimensional space. Endoscopy allows real-time monitoring of treatment progress and potential complications. For example, an operator using fluoroscopy could not identify iatrogenic haemobilia as readily as an operator using endoscopy, and delayed recognition of such a complication could have lethal consequences. Fortunately, hemorrhagic complications encountered in the IR suite can be treated by trans-arterial embolization. Endoscopic visualization also allows an operator to more precisely characterize the etiology, extent, and other specific features of a focal narrowing within the bile ducts, thus facilitating a more targeted and patient-specific approach to diagnosis and treatment. Conversely, a filling defect seen on conventional cholangiography is nonspecific and can result in an indeterminant biopsy or lead to inappropriate treatment.

Second, PTCS-guided laser incision can improve clinical outcomes and potentially be a definitive treatment option for patients with recalcitrant BBS who otherwise require life-long percutaneous drainage. Unlike mechanical dilation techniques such as balloon cholangioplasty and stenting, the holmium laser addresses the root cause of stricture by incising excess fibrotic intraluminal tissue and restoring patency to the native bile duct, while also eliminating the need for an indwelling device that can become a nidus for infection. In contrast to radiofrequency (RF) ablation or the neodymium laser, the holmium laser's short depth of penetration and selective wavelength for water absorption results in precise tissue dissection by way of vaporization, with minimal thermal damage to surrounding tissues. This results in less inflammation and trauma to the bile ducts, which are the major culprits of re-stenosis. Additionally, the device can be employed simultaneously for lithotripsy of concomitant biliary stones which must be removed at the time of intervention to prevent cholangitis and stricture recurrence.

Third, PTCS-guided laser incision has the potential to reduce patient morbidity and improve quality of life. By decreasing the total number of interventions and amount of time patients require a drainage catheter or other indwelling device, a decrease in cumulative procedural and stricture-related complications would likewise be expected. In contrast to 1 or 2 PTCS sessions, standard protocols involve multiple interventions over the course of several months, during which time patients are expected to self-manage a biliary drainage bag and continuously monitor for signs and symptoms of cholangitis and elevated bilirubin. Following a capping trial, still some 20-30% of patients develop recurrent stricture, many of whom have no other option but to continue indefinitely with a drainage tube while carrying a life-long risk of recurrent cholangitis and other obstructive phenomena. The improved efficiency of PTCS-guided laser incision also implicates a potential to decrease procedure-related costs, use of hospital and departmental resources, and radiation exposure to patients. In the past, the high overhead cost of reusable endoscopes prohibited most IR groups from adopting endoscopy. However, the development of new disposable low-profile devices has eliminated the financial barrier to entry for IR-operated endoscopy and may yield cost savings over time with less angiography suite usage.

Being tested
Percutaneous transhepatic cholangioscopic (PTCS) laser incision

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous transhepatic cholangioscopic (PTCS) laser incisionProcedure or surgery

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

Study groups in NCT05567003
Study groupRoleWhat they receive
Patients with benign biliary stricturesOtherPatients with benign biliary strictures with current or prior biliary obstruction, who would otherwise receive standard treatment with long-term biliary tube drainage.
Receives: Procedure: Percutaneous transhepatic cholangioscopic (PTCS) laser incision

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Post Procedure Adverse Events

    Safety evaluated by cumulative rates of post-interventional complications after PTCS-guided laser incision.

    1. Complications will be reported according to the Society of Interventional Radiology Adverse Event (AE) classification system.
    2. Safety will be reported as 30-day composite of all post-procedure AEs.
    3. Complications will be further qualified and quantified by AE severity category and individual AE types.

    Measured: Up to 24 months

  2. Feasibility of Procedure

    Feasibility evaluated by technical success of PTCS-guided laser incision.

    1. Technical success defined as endoscopic and cholangiographic evidence of improved patency at the time of intervention.

    Measured: Up to 24 months

Secondary outcomes (3)
  1. Primary Bile Duct Patency

    Primary bile duct patency evaluated as mean time to first stricture recurrence.

    1. Stricture recurrence will be defined as clinical and/or radiographic evidence of biliary occlusion requiring additional therapy.
    2. The date of PTCS or post-intervention biliary catheter removal will mark the time of initiation.

    Measured: Up to 24 months

  2. Tube-Free Survival

    Tube-free survival evaluated as cumulative time survived without a biliary device during the study period.

    1. Duration of time that patients require a biliary catheter or stent during follow-up period will be subtracted from the 12-month total.
    2. If a device is subsequently removed, tube-free survival time will continue to be accrued up to 12 months post-treatment.

    Measured: Up to 12 months

  3. 12-Month Cumulative Complications

    12-month cumulative complications from laser treatment or recurrent biliary disease.

    1. Composite of all PTCS- and stricture-related AEs during the 12-month follow-up period.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2022
  2. Study start1 Nov 2022
  3. Primary completion5 Jan 2024
  4. Study completion5 Feb 2024

Why it stopped: Study did not meet enrollment targets.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05567003
Sponsor's protocol ID
21-001910
Acronym
PEBBL
Status last verified
Apr 2025
First submitted
30 Sep 2022
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous transhepatic cholangioscopic (PTCS) laser incision in people with Benign Biliary Strictures With Current or Prior Biliary Obstruction, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study did not meet enrollment targets.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Post Procedure Adverse Events (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.

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