Clinical trial NCT02821546: Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis
Official title: Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatitis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP pancreatitis.

Detailed description: Patients underwent first-time ERCP were randomly assigned (1:1) to receive either LRS at a rate of 150 ml/hr starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours (aggressive hydration) or LRS at a rate calculated by the Holliday-Segar method given peri-procedurally as described earlier (standard hydration). Visual analog scale, serum amylase, lipase, C-reactive protein (CRP), and urine analysis were assessed prior to procedure and 24 hours after. The primary endpoint was post ERCP pancreatitis defined as new or increased epigastric pain persisting for ≥24 hours, elevation of amylase or lipase \>3 times the upper limit of normal.

Eligibility criteria: Inclusion Criteria:

* patients at age between 18-65 years old undergoing first time ERCP

Exclusion Criteria:

* Ongoing acute pancreatitis
* Chronic pancreaittis
* Prior sphincterotomy
* Ongoing hypotension including those with sepsis
* Cardiac insufficiency (CI, \>NYHA Class II heart failure)
* Renal insufficiency (RI, creatinine clearance \<40mL/min)
* Severe liver dysfunction (albumin \< 3mg/dL)
* Respiratory insufficiency (defined as oxygen saturation \< 90%)
* Pregnancy
* Hyponatremia (Na+ levels \< 130mEq/L))
* Hypernatremia (Na+ levels \> 150mEq/L)

Primary outcomes:
measure: post ERCP pancreatitis
timeFrame: 24 hours
Secondary outcomes:
measure: severity of post ERCP pancreatitis
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Nonthalee Pausawasdi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
citation: 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.
citation: Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available.
citation: Chang A, Pausawasdi N, Charatcharoenwitthaya P, Kaosombatwattana U, Sriprayoon T, Limsrivilai J, Prachayakul V, Leelakusolvong S. Continuous Infusion of Fluid Hydration Over 24 Hours Does Not Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis. Dig Dis Sci. 2022 Aug;67(8):4122-4130. doi: 10.1007/s10620-021-07256-z. Epub 2021 Oct 15.