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.
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
- Conditions the study is for
- Benign Biliary Strictures With Current or Prior Biliary Obstruction
- 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
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 group | Role | What they receive |
|---|---|---|
| Patients with benign biliary strictures | Other | Patients 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.
Incidence of Post Procedure Adverse Events
Safety evaluated by cumulative rates of post-interventional complications after PTCS-guided laser incision.
- Complications will be reported according to the Society of Interventional Radiology Adverse Event (AE) classification system.
- Safety will be reported as 30-day composite of all post-procedure AEs.
- Complications will be further qualified and quantified by AE severity category and individual AE types.
Measured: Up to 24 months
Feasibility of Procedure
Feasibility evaluated by technical success of PTCS-guided laser incision.
- Technical success defined as endoscopic and cholangiographic evidence of improved patency at the time of intervention.
Measured: Up to 24 months
Secondary outcomes (3)
Primary Bile Duct Patency
Primary bile duct patency evaluated as mean time to first stricture recurrence.
- Stricture recurrence will be defined as clinical and/or radiographic evidence of biliary occlusion requiring additional therapy.
- The date of PTCS or post-intervention biliary catheter removal will mark the time of initiation.
Measured: Up to 24 months
Tube-Free Survival
Tube-free survival evaluated as cumulative time survived without a biliary device during the study period.
- Duration of time that patients require a biliary catheter or stent during follow-up period will be subtracted from the 12-month total.
- 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
12-Month Cumulative Complications
12-month cumulative complications from laser treatment or recurrent biliary disease.
- 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.
- First posted5 Oct 2022
- Study start1 Nov 2022
- Primary completion5 Jan 2024
- Study completion5 Feb 2024
Why it stopped: Study did not meet enrollment targets.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Biliary Strictures With Current or Prior Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Ravi N. Srinivasa, MD, University of California, Los Angeles
- Investigators
- Ravi N Srinivasa, MD, Principal investigator, University of California, Los Angeles
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Endoscopic Laser Incision for Benign Biliary Strictures: Prospective Evaluation of Safety and Efficacy
- ClinicalTrials.gov ID
- NCT05567003
- Acronym / sponsor ID
- PEBBL / 21-001910
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study did not meet enrollment targets.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with benign biliary strictures | Other | Procedure: Percutaneous transhepatic cholangioscopic (PTCS) laser incisionPatients with benign biliary strictures with current or prior biliary obstruction, who would otherwise receive standard treatment with long-term biliary tube drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous transhepatic cholangioscopic (PTCS) laser incisionInfrared percutaneous transhepatic cholangioscopic guided holmium laser incision for treatment of benign biliary strictures. | Procedure or surgery | Patients with benign biliary strictures |
Primary outcome
Incidence of Post Procedure Adverse Events
Time frame: Up to 24 months
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.
Feasibility of Procedure
Time frame: Up to 24 months
Feasibility evaluated by technical success of PTCS-guided laser incision. a. Technical success defined as endoscopic and cholangiographic evidence of improved patency at the time of intervention.
3 secondary outcomes
Primary Bile Duct Patency
Time frame: Up to 24 months
Tube-Free Survival
Time frame: Up to 12 months
12-Month Cumulative Complications
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Study did not meet enrollment targets.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi N Srinivasa, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
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.