Biliary Laser Therapy for Benign Biliary Strictures

(PEBBL Trial)

Overseen By Aniket Joglekar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Los Angeles

Disqualifiers: Malignant stricture, Liver transplant, Sepsis, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1-2 sessions

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Percutaneous transhepatic cholangioscopic (PTCS) laser incision for benign biliary strictures?

While there is no direct data on PTCS laser incision for benign biliary strictures, similar laser-based treatments like excimer laser angioplasty have been used successfully in other medical conditions, such as coronary artery disease, to address difficult lesions. This suggests that laser technology can be effective in treating challenging blockages. ^{1 2 3 4 5}

How is the PTCS laser incision treatment different from other treatments for benign biliary strictures?

The PTCS laser incision treatment is unique because it uses a laser to precisely cut through strictures (narrowed areas) in the bile duct, which is less invasive than traditional surgery. This method allows for direct visualization and treatment of the stricture through a small incision, potentially reducing recovery time and complications compared to more invasive surgical options. ^{6 7 8 9 10}

Research Team

Ravi N Srinivasa, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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.

Inclusion Criteria

I have had signs of a blocked bile duct.

I am 18 years old or older.

I have been diagnosed with benign biliary strictures.

Exclusion Criteria

I have been diagnosed with a cancerous blockage in my bile duct.

I do not have an active infection in my bile ducts or sepsis.

I need urgent treatment to relieve bile duct blockage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PTCS-guided laser incision to treat benign biliary strictures

1-2 sessions

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits as needed

Long-term Follow-up

Participants are monitored for long-term safety and efficacy outcomes

Up to 24 months

Treatment Details

Interventions

• Percutaneous transhepatic cholangioscopic (PTCS) laser incision

Trial Overview 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.

Participant Groups

Group I: Patients with benign biliary strictures Experimental Treatment 1 Intervention

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

Percutaneous transhepatic cholangioscopic (PTCS) laser incision is already approved in United States, European Union for the following indications:

Approved in United States as PTCS Laser Incision for:

• Benign Biliary Strictures

Approved in European Union as PTCS Laser Incision for:

• Benign Biliary Strictures

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

In a study involving 12 canine subjects, excimer laser coronary angioplasty (ELCA) demonstrated safety with no perforations and minimal arterial dissection, indicating its potential as a reliable treatment method.

The first human application of ELCA showed partially successful recanalization of a blocked artery with no complications, suggesting that this technique can be effective for treating coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous excimer laser coronary angioplasty: animal models and the first human experience in Taiwan. Chen, JS., Hwang, CL., Kwan, PS., et al.[2015]

Percutaneous transhepatic cardiac catheterization is a simple and effective procedure that experienced pediatric interventionalists can perform with minimal extra training.

This technique is particularly beneficial for treating patients with complex congenital heart defects, offering a valuable option in their management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with percutaneous transhepatic cardiac catheterization in infants and children. Sommer, RJ., Golinko, RJ., Mitty, HA.[2019]

A novel bilayer superpressure balloon, made of polyethylene terephthalate (PET) and polyamide (PA12), demonstrated superior burst stress and lower compliance compared to traditional balloons, making it more effective for dilating calcified coronary lesions.

The ultrathin design of the bilayer balloon allows for easier navigation through narrow blood vessels, potentially improving the success of percutaneous transluminal coronary angioplasty procedures in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of polyethylene terephthalate/ polyamide (PET/PA) bilayer structure on physical and strength-related properties of superpressure angioplasty balloons. Lu, S., Ji, X., Yue, B., et al.[2021]

A case of unilateral microembolic retinopathy was reported one month after a percutaneous transluminal coronary angioplasty (PTCA), highlighting a rare ocular complication associated with this common cardiac procedure.

The study suggests that ocular complications from PTCA may be underestimated, as many patients may not exhibit symptoms despite experiencing partial or total occlusion of retinal blood vessels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asymptomatic unilateral microembolic retinopathy secondary to percutaneous transluminal coronary angioplasty. Teitelbaum, BA.[2010]

In a study of 487 lesions treated with various interventional devices, adjunctive percutaneous transluminal coronary angioplasty (PTCA) was successfully used in 85% of cases to improve outcomes after initial device failures, demonstrating its critical role in managing complications during coronary interventions.

The overall procedural success rate after PTCA was high at 85%, with low rates of serious complications such as Q-wave myocardial infarction (3.5%), emergency bypass surgery (1.8%), and death (2.3%), indicating that PTCA is a safe and effective adjunctive treatment in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of percutaneous transluminal coronary angioplasty after new device coronary interventions. Safian, RD., Freed, M., Lichtenberg, A., et al.[2019]

Percutaneous transhepatic cholangioscopy (PTCS) is emerging as a less invasive alternative to traditional bilioenteric reconstructive surgery for treating strictures caused by biliary surgery complications.

PTCS offers both diagnostic and therapeutic benefits for patients with bilioenteric anastomosis strictures, potentially reducing the risks associated with more invasive surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Transhepatic Cholangioscopy in Bilioenteric Anastomosis Stricture. Oh, HC.[2020]

Percutaneous transhepatic cholangioscopy (PTCS) has been successfully performed in 428 cases, allowing for accurate diagnosis of biliary tract conditions, particularly distinguishing between malignant and benign diseases.

The procedure demonstrated a high positive biopsy rate of 96% for bile duct cancer, making PTCS a reliable pre-operative diagnostic tool for evaluating biliary strictures and polyps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cholangioscopic differentiation of biliary strictures and polyps. Nimura, Y., Kamiya, J., Hayakawa, N., et al.[2008]

Percutaneous transhepatic cholangioscopy (PTCS) with balloon dilatation is a promising noninvasive treatment for benign biliary strictures, which can prevent serious complications like cholangitis and liver failure.

In a challenging case where the guidewire could not pass through a complete bilioenteric anastomosis stricture, an artificial bilioenteric fistula was successfully created using a needle-knife papillotome during PTCS, demonstrating a novel approach to manage difficult strictures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Needle-knife fistulotomy with percutaneous transhepatic cholangioscopy for managing complete bilioenteric anastomosis occlusion. Lim, JU., Joo, KR., Cha, JM., et al.[2014]

In a study of 177 patients with hilar strictures, percutaneous transhepatic cholangioscopy (PTCS) was found to significantly improve diagnostic accuracy, with a combined sensitivity of 88.4% when using both biopsy and cholangioscopic observation of tumor vessels.

PTCS not only aids in diagnosing malignant tumors but also serves a therapeutic role for some patients with incurable malignant hilar lesions, highlighting its dual utility in managing complex biliary conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of percutaneous transhepatic cholangioscopy in patients with hilar strictures. Jung, JY., Lee, SK., Oh, HC., et al.[2022]

In a study of 40 patients with benign biliary strictures, percutaneous treatment was significantly more successful (90%) compared to endoscopic treatment (43%), indicating that percutaneous approaches may be more effective for long-term management.

Both endoscopic and percutaneous treatments showed acceptable complication rates (14% for ERCP and 26% for PTBD), suggesting they are viable long-term alternatives to surgery for managing biliary strictures, although the duration and type of stenting may affect outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of endoscopic and percutaneous transhepatic treatment of benign biliary strictures. Born, P., Rösch, T., Brühl, K., et al.[2016]

References

1. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Percutaneous excimer laser coronary angioplasty: animal models and the first human experience in Taiwan. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Initial experience with percutaneous transhepatic cardiac catheterization in infants and children. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Influence of polyethylene terephthalate/ polyamide (PET/PA) bilayer structure on physical and strength-related properties of superpressure angioplasty balloons. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Asymptomatic unilateral microembolic retinopathy secondary to percutaneous transluminal coronary angioplasty. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Usefulness of percutaneous transluminal coronary angioplasty after new device coronary interventions. [2019]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Percutaneous Transhepatic Cholangioscopy in Bilioenteric Anastomosis Stricture. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Cholangioscopic differentiation of biliary strictures and polyps. [2008]

8. United States pubmed.ncbi.nlm.nih.gov

Needle-knife fistulotomy with percutaneous transhepatic cholangioscopy for managing complete bilioenteric anastomosis occlusion. [2014]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

The role of percutaneous transhepatic cholangioscopy in patients with hilar strictures. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Long-term results of endoscopic and percutaneous transhepatic treatment of benign biliary strictures. [2016]