A Randomized controlled trial comparing pre-operative high volume lactated Ringer solution combined with human albumin versus standard volume lactated Ringer solution to prevent post-endoscopic retrograde cholangio-pancreatography pancreatitis

Phase 3

• Conditions: Post ERCP Pancreatitis; Post ERCP pancreatitis

• Registration Number: TCTR20240405003
• Lead Sponsor: avamindradhiraj

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-05
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. adult patient
2. Underwent ERCP from any cause

Exclusion Criteria

1. no informed consent
2. participant who has history or in active congestive heart failure (higher than New York Heart Association class 2)
3. demonstrate sign of volume overload
4. severe comorbidity ( chronic kidney disease up to stage 3, advanced chronic obstructive pulmonary disease, and poorly controlled blood sugar)
5. history allergy of albumin solution

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post ERCP Pancreatitis 24 hours Serum amylase/Blood test

Secondary Outcome Measures

Name	Time	Method
Procedure relate risk 24 hours Serum amylase/blood test