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Cholangioscopy guided electrohydraulic lithotripsy for large common bile duct(cbd) stones- safety and feasibility evaluation of a large 1.5mm EHL probe (CRAC-Stones study) under direct vision

Cholangioscopy guided electrohydraulic lithotripsy for large common bile duct(cbd) stones- safety and feasibility evaluation of a large 1.5mm EHL probe (CRAC-Stones study) under direct vision - CRAC-Stones-Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035035
Enrollment
30
Registered
2024-09-10
Start date
2024-09-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledochilithias

Interventions

Group 1: Patients >18 years of age with a signed declaration of consent and a symptomatic DHC stone >10 mm and/or lumen-occluding stones.

Sponsors

Universitätsklinik Essen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: a) Patients aged =18years b) Signed informed consent c) Common bile duct stones = 10 mm in size and/or with lumen occlusion d) Indication for endoscopic retrograde cholangiography with cholangioscopy and electrohydraulic lithotripsy

Exclusion criteria

Exclusion criteria: a) Patients with ASA 4 or 5 according to American Society of Anesthesiologists (ASA) classification b) Pregnancy c) Uncorrected oagulopathy, defined as international normalized ratio = 2 and/or platelet count < 50/nl d) No timely interruption of treatment with antiplatelet or anticoagulant therapy except acetylsalicylic acid =100 mg/day according to recommendations by British Society of Gastroenterology and ESGE from 2021 (PMID: 34362780) e) Contraindication against endoscopic retrograde cholangiography with cholangioscopy and electrohydraulic lithotripsy and/or deep sedation at the investigator’s descretion

Design outcomes

Primary

MeasureTime frame
Technical success: Removal of stones or passability of a stent when this was not previously possible

Secondary

MeasureTime frame
1. Ability to advance the 4.5FR/1.5 mm EHL probe to the stone and apply shock waves to crack it 2. AE rate at day after procedure and 30 days after procedure 3. Number of catheters used for the primary endpoint (PE)

Countries

Germany

Contacts

Public ContactChristian Gerges

Universitätsklinik Essen

christian.gerges@uk-essen.de+4920172384880

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026