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.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

DRUG

lactated Ringer's solution (vigorous hydration arm)

* Initial bolus of lactated Ringer's solution at 10mL/kg over 1 hour prior to ERCP * Intravenous lactated Ringer's solution at a rate of 3mL/kg/h during the procedure and continued for 8 hours. * At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10mL/Kg over 1hour

DRUG

lactated Ringer's solution (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 1.5ml/kg/h during the procedure and for 8hours after ERCP.

DEVICE

endoscopic retrograde cholangiopancreatography (ERCP)

endoscopic retrograde cholangiopancreatography

Sponsors & Collaborators

• Wonkwang University

  collaborator OTHER

• University of Ulsan

  collaborator OTHER

• Dankook University

  lead OTHER

Principal Investigators

• Jun Ho Choi, MD · Dankook University College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2015-08-31

Completion

2016-06-30

Countries

• South Korea

Study Locations