Holmium Laser vs Electrohydraulic Lithotripsy for Gallstones

Overseen By Amanda Lin, DSc, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Disqualifiers: Pregnancy, Coagulopathy, Malignant stricture, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediately after the procedure

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a low-power holmium laser can safely and effectively treat large or tough bile duct or pancreatic duct stones. Researchers will compare this laser treatment to electrohydraulic lithotripsy, another method for breaking down these stones. Participants will undergo a procedure using one of these treatments to break up the stones, followed by a check-up call after 30 days. Individuals who have struggled with large bile duct or pancreatic duct stones that standard methods have not removed might find this trial suitable. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it benefits more patients.

What is the safety track record for the treatments in this trial?

Research has shown that using a low-power holmium laser to treat large bile duct stones is generally safe. Studies have found that this laser effectively breaks down stones without causing significant harm. Most patients tolerate the laser treatment well, with no major side effects reported in the reviewed studies.

Another method, electrohydraulic lithotripsy (EHL), has also demonstrated safety in past research. Like the laser, it effectively breaks down stones with minimal side effects.

Both treatments have been used successfully in previous studies, and the results suggest they are safe options for managing difficult bile duct stones. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about laser lithotripsy for gallstones because it uses a low-wattage holmium laser to break down stones in the bile duct or pancreatic duct. Unlike electrohydraulic lithotripsy, the standard method for handling large or difficult stones, laser lithotripsy offers a more precise targeting of stones with potentially less damage to surrounding tissues. This precision could lead to fewer complications and quicker recovery times for patients.

What evidence suggests that this trial's treatments could be effective for bile duct or pancreatic duct stones?

This trial will compare the effectiveness of two treatments for gallstones: Laser Lithotripsy using a low-power holmium laser and Electrohydraulic Lithotripsy. Research has shown that a low-power holmium laser effectively breaks down tough bile duct stones. One study found that this laser cleared stones larger than 28 mm in 68% of cases. Another study reported success in over 90% of cases for stones smaller than 10 mm. The holmium laser is also considered safe, especially at certain power levels. Overall, it is a reliable method for treating difficult bile duct stones. ^{2 6 7 8 9}

Who Is on the Research Team?

Neal A Mehta, MD

Principal Investigator

Rush University Medical Center, Department of Digestive Diseases and Nutrition, Center for Interventional and Therapeutic Endoscopy

Are You a Good Fit for This Trial?

Inclusion Criteria

Stone diameter ≥ 15 mm in any single dimension as measured on prior cross-sectional imaging (CT, MRCP, or EUS)

Signed written informed consent

I have a stone that cannot be removed with standard tools.

Exclusion Criteria

I have or am suspected to have a cancerous bile or pancreatic duct blockage.

Pregnancy: Repeated ERCP would be delayed until after delivery if possible

Clinically significant, uncorrectable coagulopathy (defined as INR > 1.5 or platelet count < 50,000/μL)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ERCP procedure and their bile duct or pancreatic duct stone will either be broken up with the low-power holmium laser lithotripsy device or the electrohydraulic lithotripsy device.

Immediately after the procedure

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and symptom resolution. A call is made 30 days after the procedure to document symptoms and/or any side effects.

30 days

1 call (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Electrohydraulic lithotripsy
• Laser lithotripsy with low-wattage holmium laser

How Is the Trial Designed?

Group I: Laser Lithotripsy Experimental Treatment 1 Intervention

Laser lithotripsy (LL). Use of LL to break down large/difficult bile duct or pancreatic duct stones.

Group II: Electrohydraulic Lithotripsy Active Control 1 Intervention

Electrohydraulic lithotripsy (EHL). Use of EHL to break down large/difficult bile duct or pancreatic duct stones.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6205352/

Biliary and pancreatic lithotripsy devices - PMC - NIH

Another series of 116 patients found that the cumulative probability of bile duct clearance for stones >28 mm was 68% compared with >90% for those <10 mm.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07418112

Comparing the Efficacy and Safety of Holmium Laser ...

The goal of this clinical trial is to learn if a low-power holmium laser works to treat large and/or difficult bile duct or pancreatic duct stones in adults ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6935391/

Holmium laser lithotripsy improves the rate of successful ...

This study aimed to assess the ability of laser-assisted bile duct exploration by laparoendoscopy (LABEL) to increase the rate of successful transcystic LCBDE.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0016510718317875#!

Sa1361 CHOLANGIOSCOPY-GUIDED HOLMIUM LASER ...

Using standard techniques, the treatment of bile duct stones is highly effective in 85-90% of cases. In 5-15% the stones are classified as “difficult” due ...

5.

mdpi.com

mdpi.com/1648-9144/60/2/346

Safety Parameters for the Use of Holmium:YAG Laser in ...

Conclusions: The Ho:YAG laser appears to be safe and effective in the treatment of large bile duct stones when used between 8–12 W in 5 s bursts ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10889936/

Safety Parameters for the Use of Holmium:YAG Laser ... - PMC

Conclusions: The Ho:YAG laser appears to be safe and effective in the treatment of large bile duct stones when used between 8–12 W in 5 s bursts ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37041308/

A Systematic Review and Meta-Analysis

The current meta-analysis indicated that LHLL could be more effective and safer than LBDC. However, these results should be confirmed with a ...

8.

journals.lww.com

journals.lww.com/jmsc/fulltext/2024/26020/holmium_laser_lithotripsy_in_the_management_of.36.aspx

Holmium Laser Lithotripsy in the Management of Difficult...

Ho LL has revolutionized the management of difficult biliary stone. The major limitation is cost of care and availability of expertise.

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1051044325003288

Safety and Effectiveness of Percutaneous Electrohydraulic ...

To analyze potential differences between the outcomes (including clinical success, biliary tube removal, and adverse event [AE] rates) of percutaneous ...