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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060734

Enrollment

Registered

2026-04-01

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

bile duct stone

Interventions

Mechanical lithotripsy Peroral cholangioscopy guided lithotriptsy

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Stone clearance rate during the initial session	—

Countries

Japan

Contacts

Public ContactYuki Tanisaka

Saitama Medical University International Medical Center Gastroenterology

tanisaka1205@gmail.com0429844111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026