Clinical Trial: Endoscopic Ultrasound (EUS) versus Magnetic Resonance Cholangiopancreatography (MRCP) for CT-Indeterminate Common Bile Duct Stones: A Multicenter Randomized Controlled Trial (Japan)

Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062845) titled 'Endoscopic Ultrasound (EUS) versus Magnetic Resonance Cholangiopancreatography (MRCP) for CT-Indeterminate Common Bile Duct Stones: A Multicenter Randomized Controlled Trial' on Oct. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Wakayama Medical University

Condition: Condition - Patients in which the presence of common bile duct stones is suspected due to elevated biliary enzymes but cannot be clearly confirmed on CT, and in which elective endoscopic stone removal will be performed if stones are present. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare and evaluate the diagnostic performance and usefulness of EUS versus MRCP for common bile duct stones that are difficult to diagnose on CT. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention1(EUS group): Patients allocated to this group undergo EUS as the initial examination. The presence or absence of common bile duct stones (including size and number when present) is recorded. If stones are suspected, ERCP is performed and the final diagnosis is made based on ERCP findings. If no stones are detected, MRCP is performed as the secondary examination. Interventions/Control_2 - Intervention2(MRCP group): Patients allocated to this group undergo MRCP as the initial examination. The presence or absence of common bile duct stones (including size and number when present) is recorded. If stones are suspected, ERCP is performed and the final diagnosis is made based on ERCP findings. If no stones are detected, EUS is performed as the secondary examination.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged 18 years or older at the time of obtaining consent 2. Patients in whom common bile duct stones cannot be clearly identified on CT 3. Patients with suspected or definite diagnosis of acute cholangitis according to the diagnostic criteria in the Tokyo Guidelines 2018 (Guidelines for the management of acute cholangitis and cholecystitis) 4. Patients with mild or moderate acute cholangitis according to the severity grading in the Tokyo Guidelines 2018 (Guidelines for the management of acute cholangitis and cholecystitis) 5. Patients from whom informed consent has been obtained Key exclusion criteria - 1. Patients who are pregnant, possibly pregnant, or breastfeeding 2. Patients in whom endoscopy (EUS) is difficult to perform 3. Patients in whom MRI is difficult to perform due to claustrophobia or metal implants in the body 4. Patients with ECOG Performance Status 4 5. Patients with severe comorbidities of ASA class 4 or higher (cardiac, pulmonary, renal, hepatic disease, etc.) 6. Patients with surgically altered gastrointestinal anatomy other than Billroth-I reconstruction 7. Patients with gallstone pancreatitis 8. Patients with concomitant bile duct stricture 9. Patients judged to be inappropriate for enrollment at the physician's discretion Target Size - 112

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 07 Month 08 Day Anticipated trial start date - 2024 Year 10 Month 01 Day Last follow-up date - 2031 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071841

Disclaimer: Curated by HT Syndication.