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CholedocholithiasisPhase 4NCT07418112

Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones

A Phase 4 study testing Laser lithotripsy with low-wattage holmium laser and Electrohydraulic lithotripsy in people with Choledocholithiasis and Pancreatic Duct Stone, run by Rush University Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. It will also learn about the safety of the low-wattage holmium laser. Read more about this study

Who is it for?
Ages 19 to 85 years
Conditions the study is for
Choledocholithiasis, Pancreatic Duct Stone
What is being tested?
Laser lithotripsy with low-wattage holmium laser and Electrohydraulic lithotripsy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
15 Jan 2026to Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 19 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 19-85 years
  • Signed written informed consent.
  • Presence of one or more biliary (common bile duct or intrahepatic) or pancreatic duct stones that are deemed "difficult" based on at least one of the following criteria:
  • Stone diameter ≥ 15 mm in any single dimension as measured on prior cross-sectional imaging (CT, MRCP, or EUS).
  • Presence of an impacted stone that cannot be dislodged with a standard balloon or basket.
  • Stone located proximal to a benign biliary or pancreatic duct stricture.
  • Documented failure of stone extraction during a prior ERCP attempt using standard techniques (e.g., sphincterotomy with balloon/basket extraction).

Who cannot join

  • 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).
  • Surgically altered upper gastrointestinal anatomy that precludes conventional ERCP access (e.g., Roux-en-Y gastric bypass), unless an alternative access route (e.g., laparoscopy-assisted or EUS-directed) is planned as the standard of care.
  • Known or highly suspected malignant biliary or pancreatic stricture associated with the stone.
  • Acute pancreatitis at the time of screening, unless it is gallstone pancreatitis with persistent biliary obstruction, for which ERCP is therapeutically indicated.
  • Severe cardiopulmonary disease or other comorbidities that, in the judgment of the investigator, would make the patient an unsuitable candidate for a prolonged endoscopic procedure under general anesthesia.
  • Known life expectancy of less than 6 months.
  • Inability or unwillingness to comply with study procedures or follow-up requirements.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Neal A Mehta, MD contact

3129428651

neal_a_mehta@rush.edu

Amanda Lin, DSc, CCRC contact

Amanda_F_Lin@rush.edu

United States1 site, 1 recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Amanda Lin, DSc, CCRC, 3129428651, Amanda_F_Lin@rush.edu

    Neal A Mehta, MD, 3129428651, neal_a_mehta@rush.edu

    Recruiting

Other trials in United States

About this study

Official title: Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones: A Randomized Controlled Trial

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. It will also learn about the safety of the low-wattage holmium laser. The main questions it aims to answer are:

Is the low-power holmium laser effective at treating large and/or difficult bile duct or pancreatic duct stones? Is the low-power holmium laser effective safe to use in adults? How does the low-power holmium laser compare to electrohydraulic lithotripsy for the management of large and/or difficult bile duct or pancreatic duct stones.

Read more

Participants will:

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 lithotripsy device.

Answer a call 30 days after the procedure to document symptoms and/or any side effects.

Read the detailed description

This study aims to assess two main questions. 1: Whether low-wattage holmium:YAG laser lithotripsy (using the Quanta System Litho EVO device) is safe and effective in the management large and/or difficult bile duct or pancreatic duct stones. 2: Whether low-wattage holmium:YAG laser lithotripsy is non-inferior to electrohydraulic lithotripsy in the management of large and/or difficult gallstones.

Part one of the study will investigate whether utilizing the low-wattage holmium:YAG laser lithotripsy device via single-operator cholangioscopy (SOC-LL) is safe and effective to treat large and/or difficult choledocholithiasis or pancreaticolithiasis.

Part two of the study will be a non-inferiority study to determine if SOC-LL is non-inferior for stone clearance, among other secondary outcomes, compared to electrohydraulic lithotripsy via single-operator cholangioscopy (SOC-EHL).

Patients who meet the inclusion criteria will undergo ERCP procedures and will either undergo SOC-LL or SOC-EHL to treat their large and/or difficult choledocholithiasis or pancreaticolithiasis. Stone clearance and other procedural or safety measures will be assessed after the procedure. The patient will be monitored after the procedure for adverse events and the administration of medications or admission to the hospital will be determined by the proceduralist. Roughly 30 days after the procedure the patient will be called to assess for any adverse effects as well as to determine symptom resolution.

Being tested
Laser lithotripsy with low-wattage holmium laser, Electrohydraulic lithotripsy
Keywords
Laser lithotripsy, choledocholithiasis, pancreaticolithiasis
Medical subject headings
Choledocholithiasis

What participants receive

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

  • Laser lithotripsy with low-wattage holmium laserDevice

    Also called laser lithotripsy, lithotripsy

    Use of low-wattage holmium laser for lithotripsy of large and/or difficult bile duct stones or pancreatic duct stones during ERCP.

  • Electrohydraulic lithotripsyDevice

    Also called EHL

    Use of electrohydraulic lithotripsy for management of large and/or difficult bile duct or pancreatic duct stones.

Study groups in NCT07418112
Study groupRoleWhat they receive
Laser LithotripsyExperimentalLaser lithotripsy (LL). Use of LL to break down large/difficult bile duct or pancreatic duct stones.
Receives: Device: Laser lithotripsy with low-wattage holmium laser
Electrohydraulic LithotripsyActive comparatorElectrohydraulic lithotripsy (EHL). Use of EHL to break down large/difficult bile duct or pancreatic duct stones.
Receives: Device: Electrohydraulic lithotripsy

What is being measured

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

  1. Complete stone clearance

    Complete stone clearance is defined as the lithotripsy and clearance of ductal stone fragments as confirmed on cholangiogram or pancreaticogram at the end of the index/first procedure of the study.

    Measured: Immediately after the procedure

Secondary outcomes (6)

  1. Overall complete stone clearance rate

    This describes the rate of complete stone clearance at the end of the final procedure required to completely clear stones, regardless of the number of procedures required to do so.

    Measured: Immediately after the final procedure

  2. Number of procedures

    Describes the number of ERCP procedures required to achieve complete stone clearance.

    Measured: Immediately after the final procedure

  3. Total procedure time

    Total duration of index ERCP procedure. Will also document total procedural time for all necessary ERCPs to achieve stone clearance.

    Measured: Immediately after the final procedure

  4. Total lithotripsy time

    Duration of the activation time for either the laser lithotripsy or the electrohydraulic lithotripsy devices during the study duration.

    Measured: Immediately after the final procedure

  5. Rate of rescue mechanical lithotripsy

    Describes the percentage/rate of time that the patient requires rescue mechanical lithotripsy after failure of the primary modality (SOC-LL or SOC-EHL).

    Measured: Immediately after the final procedure

  6. Length of post-procedure hospital stay

    Describes the amount of time in days the patient spent in the hospital after any and all required procedures to achieve complete stone clearance.

    Measured: Immediately after the final procedure

Timeline

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

  1. First posted18 Feb 2026
  2. Study start15 Jan 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

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
Randomised
Intervention model
Parallel groups
Model description
EHL vs. Laser lithotripsy for choledocholithiasis or pancreaticolithiasis. Single-blind RCT.
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07418112
Sponsor's protocol ID
24070901-IRB01
Status last verified
Feb 2026
First submitted
2 Feb 2026
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Study will stay at Rush no plan for multiple centers.

Publications

  • ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.

    PubMed 30979521

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Laser lithotripsy with low-wattage holmium laser and Electrohydraulic lithotripsy in people with Choledocholithiasis and Pancreatic Duct Stone, run by Rush University Medical Center 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Neal A Mehta, MD (3129428651, neal_a_mehta@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete stone clearance (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07418112, which also lists 1 linked publication.

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 18 Feb 2026.

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