Tokyo, Oct. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063170) titled 'A Study Evaluating Green Endoscopy Practices to Reduce Device Use During ERCP' on Oct. 4.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - HITO Medical Center

Condition: Condition - Common bile duct stones and common bile duct stone-induced cholangitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to verify whether the number of devices used during ERCP for common bile duct stones and associated cholangitis can be reduced-while maintaining treatment outcomes-by implementing interventions aimed at minimizing device usage from the perspective of Green Endoscopy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Endoscopists performing ERCP receive an educational session covering Green Endoscopy principles, the environmental impact of endoscopic practice, and practical strategies to reduce device use. Following the session, the following strategies are implemented, when clinically appropriate, during all ERCP sessions within the same hospitalization for common bile duct stones or associated cholangitis:

Using the cannulation function of a sphincterotome to reduce the use of separate cannulation catheters.

Using integrated devices for endoscopic sphincterotomy and papillary balloon dilation, including large-balloon dilation.

Using either a stone extraction basket or an extraction balloon alone whenever feasible.

Completing treatment with the initially selected device whenever feasible.

Planning device selection through preprocedure case discussions.

Final device selection remains at the discretion of each endoscopist, with treatment safety and efficacy taking priority. Additional devices or device changes are permitted as clinically necessary. Device use, treatment outcomes, and safety are compared with historical controls treated under usual practice before implementation.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients diagnosed with common bile duct stones or cholangitis due to common bile duct stones.

2. Patients for whom stone removal by ERCP is indicated.

3. Patients aged 20 years or older. Key exclusion criteria - 1. Patients with surgically altered gastrointestinal anatomy other than Billroth I reconstruction. 2. Patients whose primary disease is intrahepatic bile duct stones. 3. Patients with concomitant malignant biliary strictures. 4. Patients requiring a percutaneous transhepatic approach. 5. Patients from whom written informed consent for study participation cannot be obtained (post-intervention group only). Target Size - 70

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 12 Month 01 Day Date of IRB - 2026 Year 01 Month 08 Day Anticipated trial start date - 2026 Year 01 Month 08 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072299

Disclaimer: Curated by HT Syndication.