A Prospective Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis
Summary
Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several investigations in recent years. Hydration is considered a mainstay of treatment for acute pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP pancreatitis. Inclusion criteria : consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited. Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration (treatment arm) or standard hydration (standard arm). Randomization will be performed in a double blinded fashion using computer-generated random numbers. Treatment arm (vigorous hydration arm); * Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP * Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and continued for 8 hours. * At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over 1hour Standard arm (standard hydration arm); * Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after ERCP. The primary endpoint was development of post-ERCP pancreatitis, which define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal). The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of pancreatitis, and fluid overload.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-08
- Completion
- 2016-06
Outcome
Met primary endpoint
paper Post-ERCP pancreatitis developed in 11 patients in the vigorous IVFR group (4.3%) and 25 patients in the standard IVFR group (9.8%) PMID 27311618 ↗
paper (relative risk, 0.41; 95% CI, 0.20-0.86; P = .016). PMID 27311618 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lactated Ringer's solution | Unknown | 1.5 ml | Intravenous |
| Subject | lactated Ringer's solution | Unknown | 3 ml | Intravenous |