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

NCT04970030 | Unknown

• 1 other identifier: 397-2021-SPER-AUSLBO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gallstone; Lithiasis

Keywords

Gallstone, Lithiasis, ML lithotripsy, EHL lithotripsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• effective clearance of the biliary tract

  30 days

• Comparison of the safety of the treatments under study

  30 days

Study Arms (2)

mechanical intracanal (ML) lithotripsy

ACTIVE COMPARATOR

TTS mechanical lithotripter

Procedure: ML lithotripsy

electrohydraulic intracolangioscopic (EHL) lithotripsy

EXPERIMENTAL

electrohydraulic lithotripsy with Autolith probe

Procedure: EHL lithotripsy

Interventions

ML lithotripsy PROCEDURE

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.

mechanical intracanal (ML) lithotripsy

EHL lithotripsy PROCEDURE

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

electrohydraulic intracolangioscopic (EHL) lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

Azienda USL di Bologna

Bologna, Italy

RECRUITING

MeSH Terms

Conditions

Gallstones; Lithiasis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Vincenzo Cennamo, Md

CONTACT

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

Vincenzo Cennamo

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 21, 2021
• Study Start: June 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)