Indomethacin Decreases Post-ERCP Pancreatitis (Indomethacin)
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|ClinicalTrials.gov Identifier: NCT02110810|
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Post ERCP Acute Pancreatitis||Drug: Indomethacin Drug: 2.6-g suppository of glycerin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Rectal Indomethacin Decreases the Incidence of Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography in High-risk Patients|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||March 2015|
100 mg of Indomethacin suppository immediately afterwards while still under sedation
Indomethacin suppository of 100 mg immediately afterwards while still under sedation
Placebo Comparator: 2.6-g suppository of glycerin
suppository of 2.4 g of glycerin immediately afterwards while still under sedation
Drug: 2.6-g suppository of glycerin
to receive a 2.4 g of glycerin suppository immediately afterwards while still under sedation
Other Name: glycerin suppository
- Post ERCP Acute Pancreatitis [ Time Frame: 48 hours after the procedure. ]Defined as the development of new or increased abdominal pain consistent with pancreatitis, and elevated blood amylase or lipase >3 times the upper limit of normal until 24 h after the procedure, and hospitalization (or prolongation of existing hospitalization) for at least 2 nights.
- Severity of post-ERCP pancreatitis [ Time Frame: 48 hours after procedure. ]was determined according to consensus guidelines, with mild post-ERCP pancreatitis resulting in hospitalization of < 3 days, and moderate post-ERCP pancreatitis resulting in hospitalization of 4-10 days
- Acute Pancreatitis [ Time Frame: During 30 days after hospital discharge. ]Patients who developed Acute Pancreatitis after hospital discharge with presence of abdominal pain consistent with pancreatitis, and elevated blood amylase or lipase >3 times the upper limit of normal.
- Asymptomatic hyperamylasemia [ Time Frame: 48 hours after procedue. ]any amylase level at least three times above the normal serum level in the absence of abdominal pain.
- Measurement of serum amylase [ Time Frame: 2 hours post-ERCP ]measured in all patients right after procedure and during surveillance (3 hours).
- Routine laboratory examinations [ Time Frame: 2 hours after procedure and daily until hospital discharge, an expected average of 10 days. ]All laboratory exams were performed when acute pancreatitis of any etiology was established
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110810
|Department of Gastrointestinal Endoscopy and Department of Gastroenterology of the Specialties Hospital of the Western Medical Center of the Mexican Institute of Social Security.|
|Guadalajara, Jalisco, Mexico|
|Principal Investigator:||González-Ojeda Alejandro, Ph.D., M.D.||Instituto Mexicano del Seguro Social|