Pancreatitis, Acute Clinical Trial
Official title:
Epinephrine Sprayed on the Papilla and Rectal Indomethacin Versus Sterile Water Sprayed on the Papilla and Rectal Indomethacin for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Controlled Trial
NCT number | NCT02959112 |
Other study ID # | 2008 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | June 2019 |
Verified date | February 2020 |
Source | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 ml of either sterile water or a 1:10,000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure.
Status | Terminated |
Enrollment | 548 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Age 18 years or older - Patient with an indication for endoscopic retrograde cholangiopancreatography - Patient without prior endoscopic retrograde cholangiopancreatography - Patient who accept contact by telephone Exclusion Criteria: - Previous sphincterotomy - Allergy to epinephrine or indomethacin - NSAIDs use in the prior week - Pancreatic cancer located in the head - Chronic pancreatitis - Renal failure (Cr >1.4 mg / dl) - Indication for endotracheal intubation independent of endoscopic retrograde cholangiopancreatography - Biliodigestive derivation - Pregnant patients |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Mexico City | Tlalpan |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition | Consensus definition for post endoscopic retrograde cholangiopancreatography pancreatitis is: (1) new or worsened abdominal pain, (2) new or prolongation of hospitalization for at least 2 days, and (3) serum amylase or lipase 3 times or more the upper limit of normal, measured more than 24 hours after the procedure | 7 days | |
Secondary | Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk | 7 days |
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