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

NCT04970030 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-07-21

No results posted yet for this study

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

Interventions

PROCEDURE

ML lithotripsy

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.

PROCEDURE

EHL lithotripsy

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

Sponsors & Collaborators

  • Azienda Usl di Bologna

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-07-01
Completion
2023-08-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04970030 on ClinicalTrials.gov