Tailored Hydration for the Prevention of Post-ERCP Pancreatitis

Summary

Aggressive hydration of lactated Ringer's solution has shown considerable beneficial effect in preventing post-ERCP(endoscopic retrograde cholangiopancreatography) pancreatitis. But the occurence rate of post-ERCP pancreatitis are near 10% and there are severe complications of aggressive hydration due to hypervolemia such pulmonary and peripheral edema, prolonged hospital stay and increased medical expense. Also there are no definite guidelines that suggest the duration and amount of hydration.

This study evaluates the efficacy and safety of tailored hydration depending on each patient's condition that indicates the likelihood of developing post-ERCP pancreatitis.

Conditions

• Cholangiopancreatography, Endoscopic Retrograde
• Pancreatitis

Interventions

DRUG

Tailored aggressive hydration

1. Hydration with lactated Ringer's solution with rate of 3.0 milliliter(mL)/kg/hr during and after ERCP and bolus injection of 20mL/kg for 1 hour after ERCP. 2. At 4 hours after ERCP (patients with ERPD stent insertion ; 6 hours), abdominal pain and serum amylase are checked. If pain (≥ Numeric rating scale (NRS) scale 3) is absent and amylase is below 1.5 times the upper normal limit (UNL), patient starts feeding and stops hydration. If patient has any of these signs, fasting and hydration continues. 3. At 8 hours, if pain (\<NRS scale 3) is absent, patient starts feeding and stops hydration. If patient has pain (≥ NRS scale 3) and previously checked amylase or re-checked serum amylase is above 3 times the UNL, patient is regarded as post-ERCP pancreatitis and receives 3mL/kg hydration. Patient with pain (≥ NRS scale 3) and previously checked serum amylase above 1.5 times but below 3 times the UNL, serum amylase is re-checked.

DRUG

Tailored standard hydration

1. Hydration with lactated Ringer's solution with rate of 1.5milliliter(mL)/kg/hr during and after ERCP. 2. At 4 hours after ERCP (patients with ERPD stent insertion ; 6 hours), abdominal pain and serum amylase are checked. If pain (≥ Numeric rating scale (NRS) scale 3) is absent and amylase is below 1.5 times the UNL(upper normal limit), patient starts feeding and stops hydration. If patient has any of these signs, fasting and hydration continues. 3. At 8 hours, if pain (\<NRS scale 3) is absent, patient starts feeding and stops hydration. If patient has pain (≥ NRS scale 3) and previously checked amylase or re-checked serum amylase is above 3 times the UNL, patient is regarded as post-ERCP pancreatitis and receives 3mL/kg hydration. Patient with pain (≥ NRS scale 3) and previously checked serum amylase above 1.5 times but below 3 times the UNL, serum amylase is re-checked.

Sponsors & Collaborators

• Chonbuk National University Hospital

  collaborator OTHER

• Wonkwang University Hospital

  collaborator OTHER

• Kwangju christian hospital

  collaborator UNKNOWN

• Presbyterian medical center

  collaborator UNKNOWN

• Chonnam National University Hospital

  lead OTHER

Principal Investigators

• Chang-Hwan Park, M.D, Ph.D · Chonnam National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2022-01-31

Completion

2023-10-04

Countries

• South Korea

Study Locations