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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05664074
Other study ID # 2022-0640
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 7, 2022
Est. completion date June 1, 2024

Study information

Verified date February 2024
Source Children's Hospital Medical Center, Cincinnati
Contact Tyler Thompson, BS
Phone 513-517-1055
Email tyler.thompson@cchmc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. There have been no studies comparing the effectiveness of these medications in preventing PEP in pediatric patients. You are being asked to take part in this research study because you are scheduled to have an ERCP as part of your medical care.


Recruitment information / eligibility

Status Recruiting
Enrollment 192
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 21 Years
Eligibility Inclusion Criteria: - Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla) - Age 6 month- 21 years old - Does not meet exclusion criteria Exclusion Criteria: - < 10 kg - Low risk subgroup: Biliary indication with history of prior biliary sphincterotomy. - High risk for bleeding (Example: Planned liver biopsy) - Gastrointestinal bleeding in previous 3 days - Acute pancreatitis (within 3 days) at the time of ERCP - Use of NSAIDs in the previous 5 days - Peptic ulcer disease - Acute kidney Injury or Known Chronic Kidney Disease per KDIGO - Pregnancy (Pregnancy tests are administered prior to ERCP as standard of care) - Lithium therapy - Allergy to ketorolac or indomethacin - Organ Dysfunction or SIRS

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rectal indomethacin
Dosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
IV ketorolac
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
David Vitale MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-ERCP Pancreatitis Number of patient who develop Post-ERCP Pancreatitis-
Post ERCP Pancreatitis: A patient must have at least 2 of the following to establish a diagnosis of post ERCP pancreatitis:
Characteristic physical exam findings- pain worse than admission per pain scales (please see point 2) and/or nausea
Amylase (unit/L) or lipase(unit/L) greater than 3 times the age appropriate upper limit of normal.
Normal range of amylase (15-127 unit/L)
Normal range of lipase (12-50 unit/L)
Confirmatory imaging (Ultrasound, CT or MRI) that suggests or demonstrates pancreatic inflammation
2 weeks
Secondary Pain assessed by FLACC or NRS scoring post ERCP A minimum of 3 pain assessments are to be completed by nursing staff/anesthesia during admission:
Anesthesia/ PACU- initial pain assessment Evening-2100- pain assessment by RN Morning -0800- pain assessment by RN
Face, Legs, Activity, Cry, and Consolability (FLACC) Pain scale for patients 0-5 years of age and patients unable to verbalize pain
Numeric Rating Scale (NRS) Pain scale for patients 6 years old and above
Mild- 0 to 3
Moderate- 4 to 6
Severe- 7 to 10
2 weeks
Secondary Laboratory markers associated PEP (Amylase and Lipase) Amylase (unit/L) Lipase (unit/L) 2 weeks
Secondary Length of stay 2 weeks
Secondary Severity of pancreatitis (mild, moderately severe, severe) Severity of Acute Pancreatitis (AP): Severity of AP will be classified as mild, moderately severe, or severe in accordance with the NASPGHAN Classification system.
Mild: "AP that is not associated with any organ failure, local or systemic complications, and usually resolves within the first week after presentation."
Moderately Severe: "AP with either the development of transient organ failure/dysfunction (lasting no >48 hours) or development of local or systemic complications. Local complications would include development of (peri) or pancreatic complications including fluid collections or necrosis. Systemic complications would include exacerbation of previously diagnosed co-morbid disease (such as lung disease or kidney disease)."
Severe: "AP with development of organ dysfunction per International pediatric sepsis consensus conference that persists >48 hours. Persistent organ failure may be single or multiple, and may develop beyond the first 48 hours of presentation."
2 weeks
Secondary C-Reactive Protein (CRP) level Measured in mg/dL 2 weeks
Secondary Post-ERCP bleeding 2 weeks
Secondary White Blood Cell per/mcL 2 weeks
Secondary Red Blood Cell per/mcL 2 weeks
Secondary Hemoglobin gm/dL 2 weeks
Secondary Hematocrit 2 weeks
Secondary MCV fL 2 weeks
Secondary MCH pg 2 weeks
Secondary MCHC gm/dL 2 weeks
Secondary RDW 2 weeks
Secondary PLATELET per/mcL 2 weeks
See also
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Completed NCT00222092 - Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers Phase 4
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Not yet recruiting NCT06260878 - Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis Phase 4
Not yet recruiting NCT04770857 - Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis
Completed NCT02641561 - Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis Phase 3
Active, not recruiting NCT04145336 - 7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients N/A
Completed NCT03629600 - Trial of Aggressive Hydration Versus Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis Phase 2/Phase 3
Recruiting NCT03756116 - Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide N/A
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Recruiting NCT05267379 - An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Recruiting NCT05947461 - Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac N/A
Completed NCT03098082 - Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis N/A
Recruiting NCT02839356 - Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis Phase 4
Recruiting NCT02830984 - ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP N/A
Completed NCT01673763 - Post-ERCP Pancreatitis Prevention by Stent Insertion N/A
Active, not recruiting NCT04425993 - Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention N/A