UnknownNot Applicable

Comparison Between Mechanical Intracanal (ML) Lithotripsy and Electrohydraulic Intracolangioscopic (EHL) Lithotripsy in the Treatment of Difficult Main Biliary Tract Lithiasis

Italy50 participantsStarted 2021-06-01

Plain-language summary

Difficult gallstones are found in about 10-15% of endoscopic retrograde cholangiopancreaticography (ERCP) performed for choledocholithiasis. There are several options for the treatment of difficult biliary lithiasis including mechanical lithotripsy and peroral cholangioscopy with electrohydraulic lithotripsy. The primary purpose of this study is to compare the effectiveness of treating difficult biliary lithiasis with ML and with EHL. The effectiveness is defined by the complete cleanliness of the biliary tract in a single endoscopic session

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- All patients with "difficult" biliary tract lithiasis that could not be treated by standard techniques, such as balloon and/or basket catheter under fluoroscopic vision. Exclusion Criteria: * surgically-altered gastrointestinal anatomy * any evidence of biliopancreatic malignancy * patients under 18 years of age * patients in a state of pregnancy or are breastfeeding * no informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ML - EHL comparison

Timeframe: 1 day

Trial details

NCT IDNCT04970030

SponsorAzienda Usl di Bologna

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-07-01

Contact for this trial

Vincenzo Cennamo, Md

+39 051 6478844 vincenzo.cennamo@ausl.bo.it

View on ClinicalTrials.gov More Gallstone trials