A Prospective Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
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.