Clinical Trial: Efficacy and Safety of Clinically Feasible Ringer's Solution-Based Aggressive Hydration for the Prevention of Post-ERCP Pancreatitis: A Multicenter Pilot Single-Arm Trial (Japan)

Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059983) titled 'A Study to Evaluate the Safety and Effectiveness of Ringer's Solution Hydration for Preventing Pancreatitis After ERCP' on April 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Kobe University

Condition: Condition - biliary disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy and safety of prophylactic aggressive hydration for post-ERCP pancreatitis (PEP) in a multicenter pilot single-arm study. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Aggressive hydration: On the day of ERCP, administer lactated Ringer's solution or acetate Ringer's solution as a continuous infusion at 2.5 mL/kg/hr for 24 hours. Alternatively, administer a 24-hour continuous infusion of lactated or acetate Ringer's solution in the volume calculated according to the table below.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - (1) Patients who require ERCP for diagnosis and/or treatment via a biliary approach (2) Patients with no history of endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilatation (EPBD) (3) Patients aged >18 and 100 pg/mL or serum NT-proBNP > 400 pg/mL

(2) Patients with renal dysfunction (eGFR 147 mEq/L)

(7) Patients with physical findings suggesting fluid overload, such as peripheral edema or pulmonary edema

(8) Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) >= 3

(9) Patients who require ERCP via a pancreatic duct approach for diagnostic or therapeutic purposes

(10) Patients with surgically altered gastrointestinal anatomy other than Billroth I reconstruction

(11) Patients in whom papillary access is impossible or expected to be impossible because of organic gastrointestinal stenosis or similar conditions

(12) Pregnant women or women who may be pregnant

(13) Patients whom the principal investigator or subinvestigator judges to be inappropriate for inclusion in this study Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 03 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2026 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068611

Disclaimer: Curated by HT Syndication.