High-volume lactated Ringer's solution with human albumin versus standard-volume infusion as a prophylactic treatment for post-endoscopic retrograde cholangiopancreatography pancreatitis: randomized clinical trial

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240405003

Enrollment

300

Registered

2024-04-05

Start date

2023-05-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post ERCP Pancreatitis Post ERCP pancreatitis

Interventions

Lactated ringer solution intravenous hydration pre-operative for ERCP,Lactated Ringer solution and 5%human albumin intravenous hydration solution infusion pre-operative for ERCP

Experimental Drug,Experimental Drug

Lactated ringer solution intravenous hydration pre-operative for ERCP,Ringer lactate and Human albumin solution intravenous hydration pre-operative for ERCP

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. adult patient 2. Underwent ERCP from any cause

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Post ERCP Pancreatitis 24 hours Serum amylase/Blood test	—

Secondary

Measure	Time frame
Procedure relate risk 24 hours Serum amylase/blood test	—

Countries

Thailand

Contacts

Public ContactPakkapol Sukhvibul

Navamindhadhiraj

svb.arm@gmail.com0816962552

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

High-volume lactated Ringer&#039;s solution with human albumin versus standard-volume infusion as a prophylactic treatment for post-endoscopic retrograde cholangiopancreatography pancreatitis: randomized clinical trial