Clinical trial NCT03561441: Tailored Hydration for the Prevention of Post-ERCP Pancreatitis
Official title: Tailored Hydration for the Prevention of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Pancreatitis
Keywords: Endoscopic retrograde pancreatocholangiography
Pancreatitis
Lactate ringer's solution
Tailored therapy
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Chonbuk National University Hospital
name: Wonkwang University Hospital
name: Kwangju christian hospital
name: Presbyterian medical center
First posted: 2018-06-19
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of post-ERCP pancreatitis
timeFrame: 24 hours
Secondary outcomes:
measure: Clinical volume overload
timeFrame: 24 hours
measure: Hyperamylasemia
timeFrame: 24 hours
measure: Increased abdominal pain
timeFrame: 24 hours
measure: Hospital stay
timeFrame: 1 year
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Chang-Hwan Park, M.D, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
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: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.