Tailored Hydration for the Prevention of Post-ERCP Pancreatitis

November 5, 2023 updated by: Chang Hwan Park, Chonnam National University Hospital

Tailored Hydration for the Prevention of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ERCP(Endoscopic retrograde cholangiopancreatography) is the gold standard of diagnosis and treatment of pancreatobiliary disease. Pancreatitis is the most common complication after ERCP and can be lethally fatal.

The most fundamental modality of preventing and treatment of post-ERCP pancreatitis is hydration and recent studies showed considerable preventive effect of aggressive hydration of lactated Ringer's solution. Lactated Ringer's solution has very low risk of adverse reaction and low cost compared to other preventive modalities such as octreotide, corticosteroids and protease inhibitors.

Despite of these advantages of aggressive hydration of lactated Ringer's solution, the occurence rate of post-ERCP pancreatitis is near 10% and severe complications can develop due to hypervolemia caused by aggressive hydration such as pulmonary and peripheral edema, prolonged hospital stay and increased medical expense. Most of post-ERCP pancreatitis occur within several hours after ERCP and outpatients department based ERCP is suggested in some clinics by selecting patients with low risk of post-ERCP pancreatitis. A study compared the occurrence of post-ERCP pancreatitis between group with early feeding (4 hours after ERCP) and group with conventional feeding (24 hours after ERCP) and showed no difference. The most sensitive marker for predicting post-ERCP pancreatitis is abdominal pain and the occurrence time differs by whether endoscopic retrograde pancreatic duct (ERPD) stent insertion was performed or not. Patients without ERPD stent mostly develops abdominal pain at 2 hour after ERCP (0.5-2.5 hours) and patients with ERPD stent at 5 hour (0-68 hours). Also elevation of serum amylase level above 1.5 times the upper normal range after 4 hours of ERCP was suggested as useful marker for prediction of post-ERCP pancreatitis (AUROC 88.2%, 95% confidence interval 80.4%-90.6%).

The effectiveness of hydration for preventing post-ERCP pancreatitis is widely accepted but there are no definite guidelines that suggest the duration and amount of hydration.

Therefore, the purpose of this study is to evaluate the safety and efficacy of tailored hydration therapy based on markers that predicts the risk of post-ERCP pancreatitis development.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients older than 20 years undergoing ERCP for the 1st time will be recruited

Exclusion Criteria:

  • Age below 20 or above 80 years
  • Underlying severe psychiatric illness
  • Cardiac insufficiency (>New York Heart Association Class II heart failure)
  • Renal insufficiency (eGFR <30mililiter/min/1.73m2)
  • Respiratory insufficiency (defined as oxygen saturation < 90%)
  • Poorly controlled blood sugar
  • Ongoing hypotension including those with sepsis
  • Ongoing acute pancreatitis
  • Underlying disease of chronic pancreatitis
  • Clinical signs of hypervolemia
  • Hyponatremia (Na+ levels < 130 milliequivalent (mEq)/L))
  • Hypernatremia (Na+ levels > 150mEq/L)
  • Hyperkalemia (5.1 mEq/dL)
  • Metabolic alkalosis
  • Past history of endoscopic sphincterectomy or endoscopic papillary balloon dilatation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tailored standard hydration
Patients will be randomly allocated to tailored standard hydration arm. Patients will receive hydration with lactated Ringer's solution with rate of 1.5 milliliter(mL)/kg/hr during and after ERCP. Hydration and feeding will be tailored by each patient's symptoms and serum amylase levels.
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 (
Experimental: Tailored aggressive hydration
Patients will be randomly allocated to tailored aggressive hydration arm. Patients will receive 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 over 1 hour after ERCP. Hydration and feeding will be tailored by each patient's symptoms and serum amylase levels.
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 (

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of post-ERCP pancreatitis
Time Frame: 24 hours
Defined as pancreatic pain (≥ 3 on visual analogue numeric pain rating scale (0-10)) and serum amylase level 3 times the upper limit of normal.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical volume overload
Time Frame: 24 hours
Defined by physical findings of peripheral edema and pulmonary rales
24 hours
Hyperamylasemia
Time Frame: 24 hours
Elevated serum amylase level above than upper limit of normal
24 hours
Increased abdominal pain
Time Frame: 24 hours
Defined as an increase in abdominal pain based on the visual analogue numeric pain rating score (0-10) following the ERCP compared to the score immediately prior to the ERCP.
24 hours
Hospital stay
Time Frame: 1 year
Whole duration of hospital admission days
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Collaborators

Chonbuk National University Hospital
Wonkwang University Hospital
Presbyterian medical center
Kwangju christian hospital

Investigators

  • Study Director: Chang-Hwan Park, M.D, Ph.D, Chonnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

October 4, 2023

Study Registration Dates

First Submitted

June 3, 2018

First Submitted That Met QC Criteria

June 17, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNUH-2018-080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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