Tailored Hydration for the Prevention of Post-ERCP Pancreatitis

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561441
• Other study ID #: CNUH-2018-080
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: October 4, 2023

Study information

• Verified date: November 2023
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: October 4, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Pancreatitis

Intervention

Drug:
• Tailored aggressive hydration
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. 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. 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
Hydration with lactated Ringer's solution with rate of 1.5milliliter(mL)/kg/hr during and after ERCP. 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. 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.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (5)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Chonbuk National University Hospital, Kwangju christian hospital, Presbyterian medical center, Wonkwang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical volume overload	Defined by physical findings of peripheral edema and pulmonary rales	24 hours
Secondary	Hyperamylasemia	Elevated serum amylase level above than upper limit of normal	24 hours
Secondary	Increased abdominal pain	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
Secondary	Hospital stay	Whole duration of hospital admission days	1 year