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

Study Overview
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Brief Summary
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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

Detailed Description
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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. The secondary objectives of the study are as follows: Within 30 days of the procedure, the effective clearance of the biliary tract will be assessed with CholangioRM (or EUS where MRI is contraindicated). If residual choledocholithiasis is present, patients will be considered as late failures. Comparison of the safety of the treatments under study, defined by the incidence of adverse events during the procedure (e.g. perforation, hemobilia) and in the observation period after the procedure (e.g. cholangitis, pancreatitis, bleeding). Patients that can be enrolled: 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. Patients cannot be enrolled: if they have a surgically-altered gastrointestinal anatomy if they have any evidence of biliopancreatic malignancy if they are under 18 years of age if they are in a state of pregnancy or are breastfeeding if it's impossible to obtain informed consent If, while performing ERCP for choledocholithiasis, stones are found that cannot be removed using standard treatment, they will be treated by assigning these patients to either the treatment group with ML under fluoroscopic vision or to the EHL treatment group. Patients will be assigned using a randomization method in blocks with a ratio of 1:1 for each patient enrolled. Subjects will undergo ERCP, either under general anesthesia, or under observation by an anesthesiologist, and depending on which group they have been assigned to, will be treated with: EHL: after administration of IV antibiotic therapy, we will proceed to cholangioscopy with SpyGlass ™ DS (Boston Scientific Corporation, USA), treatment of difficult biliary lithiasis with electrohydraulic lithotripsy with Autolith probe (Northgate Technologies Inc USA) and subsequent complete cleaning of the biliary tract using the fluoroscopic technique. ML: we will proceed under fluoroscopic vision with TTS mechanical lithotripter (Trapezoid, RX Wireguided Retrieval Basket, Boston Scientific) with mechanical fragmentation of the stone and subsequent complete cleaning of the biliary tract using the fluoroscopic technique. During each procedure, the following will be recorded: the execution time from the insertion of the cholangioscope or lithotripter inside the biliary tract until the complete cleaning of the biliary tract is finished. the occurrence of possible adverse events related to the procedures and/or anesthetic issues. any failure of a technique and / or the need to switch a patient to the other treatment group. At least 50 patients eligible for the study will be required.

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

Conditions
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Gallstone, Lithiasis

Intervention / Treatment
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* Procedure: ML lithotripsy
* Procedure: EHL lithotripsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mechanical intracanal (ML) lithotripsy<br>TTS mechanical lithotripter | Procedure: ML lithotripsy<br>* we will proceed under fluoroscopic vision with TTS mechanical lithotripter (Trapezoid, RX Wireguided Retrieval Basket, Boston Scientific) with mechanical fragmentation of the stone and subsequent complete cleaning of the biliary tract using the fluoroscopic technique.<br>|
| Experimental: electrohydraulic intracolangioscopic (EHL) lithotripsy<br>electrohydraulic lithotripsy with Autolith probe | Procedure: EHL lithotripsy<br>* after administration of IV antibiotic therapy, we will proceed to cholangioscopy with SpyGlass ™ DS (Boston Scientific Corporation, USA), treatment of difficult biliary lithiasis with electrohydraulic lithotripsy with Autolith probe (Northgate Technologies Inc USA) and subsequent complete cleaning of the biliary tract using the fluoroscopic technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ML - EHL comparison | 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective clearance of the biliary tract | Within 30 days of the procedure, the effective clearance of the biliary tract will be assessed with CholangioRM (or EUS where MRI is contraindicated). If residual choledocholithiasis is present, patients will be considered as late failures. | 30 days | 
| Comparison of the safety of the treatments under study | Comparison of the safety of the treatments under study, defined by the incidence of adverse events during the procedure (e.g. perforation, hemobilia) and in the observation period after the procedure (e.g. cholangitis, pancreatitis, bleeding). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gallstone, Lithiasis, ML lithotripsy, EHL lithotripsy