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

Overview

Journal BJS Open

Publisher Oxford University Press

Date 2025 Jan 21

PMID 39836543

Authors

Ekaphan Shatsnimitkul

Issaree Laopeamthong

Amarit Tansawet

Suphakarn Techapongsatorn

Wisit Kasetsermwiriya

Poramet Leungon

Pakkapol Sukhvibul

Affiliations

Soon will be listed here.

Abstract

Background: Adverse events after endoscopic retrograde cholangiopancreatography (ERCP) are rare, and post-ERCP pancreatitis is a serious adverse event. This study aimed to determine the role of aggressive intravenous hydration with lactated Ringer's solution at a specific volume with 20% human albumin before ERCP in reducing the incidence of post-ERCP pancreatitis.

Methods: This study was a single-centre randomized clinical trial. The participants were randomly assigned to two groups: those who received aggressive intravenous hydration with 20% human albumin and lactated Ringer's solution (intervention group), and those who received standard-volume intravenous hydration with lactated Ringer's solution (control group). The primary endpoint was post-ERCP pancreatitis. Participants and outcome assessors were blinded to treatment allocation. Comparison was performed using the chi-square, the Fisher's exact, the Student's t, or the Mann-Whitney U tests, where appropriate.

Results: Of 300 randomized participants, 149 and 144 participants from the intervention and control group were included in the analysis. There was no significant difference in the post-ERCP pancreatitis rate (n = 10; 6.7% versus n = 9; 6.3%, P = 0.873) between the intervention and control groups. High-risk procedures (that is pancreatic duct wiring, pancreatic duct injection, precut sphincterotomy, and balloon dilation of the ampulla) were significantly associated with post-ERCP pancreatitis compared with low-risk procedures (n = 15; 15% versus n = 4; 2.1%, P < 0.001). In the high-risk procedures population, the intervention and control groups had increased post-ERCP pancreatitis rates (P = 0.716). Two participants in each group developed pulmonary congestion.

Conclusion: Aggressive peri-ERCP intravenous hydration with lactated Ringer's solution combined with 50 ml of 20% human albumin did not prevent post-ERCP pancreatitis. None of the subgroups presented with prophylactic effects.

Trial Registration: Thai Clinical Trials Registry (TCTR20240405003).

Citing Articles

Beyond fluid therapy to prevent post-endoscopic retrograde cholangiopancreatography: is there a place for albumin?.

Guilabert L, de-Madaria E BJS Open. 2025; 9(1).

PMID: 39836542 PMC: 11749779. DOI: 10.1093/bjsopen/zrae159.

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