Choledochilithias
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Technical success: Removal of stones or passability of a stent when this was not previously possible | — |
Secondary
| Measure | Time 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
Universitätsklinik Essen