Clinical Trial: Cholangioscopy-guided lithotripsy Randomized comparison with the Use of mechanical lithotripsy for Stones with High-difficulty in patients with Roux-en-Y gastrectomy using balloon enteroscope: Japan multicenter trial (Japan)

Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060734) titled 'Cholangioscopy-guided lithotripsy Randomized comparison with the Use of mechanical lithotripsy for Stones with High-difficulty in patients with Roux-en-Y gastrectomy using balloon enteroscope: Japan multicenter trial' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Saitama Medical University International Medical Center

Condition: Condition - bile duct stone Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the treatment outcomes of cholangioscopy-guided lithotripsy and mechanical lithotripsy using a mechanical lithotripter in patients with Roux-en-Y reconstruction after gastrectomy in a multicenter randomized controlled trial. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Mechanical lithotripsy Interventions/Control_2 - Peroral cholangioscopy guided lithotriptsy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with bile duct stones detected by imaging examinations such as abdominal ultrasonography, CT, MRI, or other modalities 2. Patients who have undergone Roux-en-Y reconstruction after gastrectomy and are scheduled to undergo endoscopic stone removal using balloon-assisted endoscopy 3. Patients with stones measuring 15 mm or more in maximum diameter, or with multiple stones (three or more) including at least one stone measuring 10 mm or more in maximum diameter (as measured on pre-procedural imaging) 4. Patients aged 20 years or older at the time of informed consent 5. Patients with an ECOG Performance Status score of 0-2 6. Patients from whom written informed consent for participation in this study has been obtained Key exclusion criteria - 1. Patients who have not undergone gastrointestinal reconstruction surgery, or who have undergone reconstruction procedures other than Roux-en-Y reconstruction after gastrectomy 2. Patients in whom discontinuation or substitution of antithrombotic agents is required but cannot be performed when conducting high bleeding-risk endoscopic procedures, as described in the guidelines for gastrointestinal endoscopy in patients receiving antithrombotic or anticoagulant therapy. In addition, patients with valvular atrial fibrillation receiving warfarin whose anticoagulation cannot be maintained within the therapeutic range 3. Patients with severe cholangitis (TG18 grade III) in whom cholangioscopic procedures are considered high risk 4. Patients with poor general condition (ECOG Performance Status score 3 or4) 5. Female patients who may be pregnant Target Size - 66

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 04 Day Date of IRB - 2026 Year 02 Month 04 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069483

Disclaimer: Curated by HT Syndication.