Tokyo, July 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062189) titled 'Comparison of the textbook diagnostic outcome of dual-operator and single-operator peroral cholangioscopy' on July 20.

Study Type: Interventional

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

Primary Sponsor: Institute - Pancreatobiliary Advanced Medical Center, Osaka Medical and Pharmaceutical University Hospital

Condition: Condition - Biliary stricture Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To compare single-operator and dual-operator peroral cholangioscopy in patients with biliary stricture and to evaluate the achievement rate of textbook diagnostic outcome during the initial ERCP. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single-operator POCS group. After biliary cannulation, papillary treatment, and guidewire placement, a single operator manipulates both the duodenoscope and the cholangioscope. The cholangioscope is inserted into the bile duct, the target lesion is observed, and targeted biopsy is performed. If the assigned procedure is not completed within 10 minutes, crossover to the dual-operator method is permitted. Interventions/Control_2 - Dual-operator POCS group. After biliary cannulation, papillary treatment, and guidewire placement, one operator manipulates the duodenoscope and another operator manipulates the cholangioscope. The cholangioscope is inserted into the bile duct, the target lesion is observed, and targeted biopsy is performed. If the assigned procedure is not completed within 10 minutes, crossover to the single-operator method is permitted.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Hospitalized patients with biliary stricture. 2. Age 18 years or older and less than 99 years at enrollment. 3. Patients with normal anatomy or Billroth I reconstruction. 4. Written informed consent obtained from the patient. Key exclusion criteria - 1. Surgically altered anatomy other than Billroth I reconstruction. 2. Uncontrolled cholangitis. 3. ECOG performance status 4. 4. Patients with bleeding tendency. Target Size - 270

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 15 Day Anticipated trial start date - 2026 Year 07 Month 20 Day Last follow-up date - 2030 Year 08 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071166

Disclaimer: Curated by HT Syndication.