Tailored Hydration for the Prevention of Post-ERCP Pancreatitis

NCT03561441 | Completed

• 1 other identifier: CNUH-2018-080
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endoscopic retrograde pancreatocholangiography; Pancreatitis; Lactate ringer's solution; Tailored therapy

Outcome Measures

Primary Outcomes (1)

• Development of post-ERCP pancreatitis

  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 Outcomes (4)

• Clinical volume overload

  24 hours

• Hyperamylasemia

  24 hours

• Increased abdominal pain

  24 hours

• Hospital stay

  1 year

Study Arms (2)

Tailored standard hydration

ACTIVE COMPARATOR

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

Tailored aggressive hydration

EXPERIMENTAL

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

Interventions

Tailored aggressive hydration DRUG

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.

Tailored aggressive hydration

Tailored standard hydration DRUG

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.

Tailored standard hydration

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Chonbuk National University Hospital: collaborator
• Wonkwang University Hospital: collaborator
• Kwangju christian hospital: collaborator
• Presbyterian medical center: collaborator

Study Sites (1)

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Related Publications (9)

• ASGE Standards of Practice Committee; Anderson MA, Fisher L, Jain R, Evans JA, Appalaneni V, Ben-Menachem T, Cash BD, Decker GA, Early DS, Fanelli RD, Fisher DA, Fukami N, Hwang JH, Ikenberry SO, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Shergill AK, Dominitz JA. Complications of ERCP. Gastrointest Endosc. 2012 Mar;75(3):467-73. doi: 10.1016/j.gie.2011.07.010. No abstract available.

  PMID: 22341094 BACKGROUND

• Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2014 Feb;12(2):303-7.e1. doi: 10.1016/j.cgh.2013.07.026. Epub 2013 Aug 3.

  PMID: 23920031 BACKGROUND

• Choi JH, Kim HJ, Lee BU, Kim TH, Song IH. Vigorous Periprocedural Hydration With Lactated Ringer's Solution Reduces the Risk of Pancreatitis After Retrograde Cholangiopancreatography in Hospitalized Patients. Clin Gastroenterol Hepatol. 2017 Jan;15(1):86-92.e1. doi: 10.1016/j.cgh.2016.06.007. Epub 2016 Jun 14.

  PMID: 27311618 BACKGROUND

• Andriulli A, Leandro G, Federici T, Ippolito A, Forlano R, Iacobellis A, Annese V. Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis. Gastrointest Endosc. 2007 Apr;65(4):624-32. doi: 10.1016/j.gie.2006.10.030.

  PMID: 17383459 BACKGROUND

• Rabago L, Guerra I, Moran M, Quintanilla E, Collado D, Chico I, Olivares A, Castro JL, Gea F. Is outpatient ERCP suitable, feasible, and safe? The experience of a Spanish community hospital. Surg Endosc. 2010 Jul;24(7):1701-6. doi: 10.1007/s00464-009-0832-5. Epub 2010 Jan 1.

  PMID: 20044765 BACKGROUND

• Jeurnink SM, Poley JW, Steyerberg EW, Kuipers EJ, Siersema PD. ERCP as an outpatient treatment: a review. Gastrointest Endosc. 2008 Jul;68(1):118-23. doi: 10.1016/j.gie.2007.11.035. Epub 2008 Mar 4.

  PMID: 18308308 BACKGROUND

• Park CH, Jung JH, Hyun B, Kan HJ, Lee J, Kae SH, Jang HJ, Koh DH, Choi MH, Chung MJ, Bang S, Park SW. Safety and efficacy of early feeding based on clinical assessment at 4 hours after ERCP: a prospective randomized controlled trial. Gastrointest Endosc. 2018 Apr;87(4):1040-1049.e1. doi: 10.1016/j.gie.2017.09.021. Epub 2017 Sep 28.

  PMID: 28964747 BACKGROUND

• Kerdsirichairat T, Attam R, Arain M, Bakman Y, Radosevich D, Freeman M. Urgent ERCP with pancreatic stent placement or replacement for salvage of post-ERCP pancreatitis. Endoscopy. 2014 Dec;46(12):1085-94. doi: 10.1055/s-0034-1377750. Epub 2014 Sep 12.

  PMID: 25216326 BACKGROUND

• Cho E, Kim SH, Park CH, Yoon JH, Lee SO, Kim TH, Chon HK. Tailored Hydration With Lactated Ringer's Solution for Postendoscopic Retrograde Cholangiopancreatography Pancreatitis Prevention: A Randomized Controlled Trial. Am J Gastroenterol. 2024 Dec 1;119(12):2426-2435. doi: 10.14309/ajg.0000000000002903. Epub 2024 Jun 24.

  PMID: 38912692 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Chang-Hwan Park, M.D, Ph.D

  Chonnam National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2018
• First Posted: June 19, 2018
• Study Start: January 1, 2019
• Primary Completion: January 31, 2022
• Study Completion: October 4, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)