Tailored Hydration for the Prevention of Post-ERCP Pancreatitis

NACompletedINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

January 31, 2022

Study Completion Date

October 4, 2023

Conditions
Cholangiopancreatography, Endoscopic RetrogradePancreatitis
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."

Trial Locations (1)

61469

Chonnam National University Hospital, Gwangju

All Listed Sponsors
collaborator

Chonbuk National University Hospital

OTHER

collaborator

Wonkwang University Hospital

OTHER

collaborator

Kwangju christian hospital

UNKNOWN

collaborator

Presbyterian medical center

UNKNOWN

lead

Chonnam National University Hospital

OTHER

NCT03561441 - Tailored Hydration for the Prevention of Post-ERCP Pancreatitis | Biotech Hunter | Biotech Hunter