Epinephrine Sprayed on the Papilla Versus Sterile Water Sprayed on the Papilla for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02959112
• Date of registration: 31/10/2016
• Prospective Registration: No
• Primary sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Public title: Epinephrine Sprayed on the Papilla Versus Sterile Water Sprayed on the Papilla for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography
• Scientific 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
• Date of first enrolment: May 2016
• Target sample size: 548
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02959112
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Mexico

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pancreatitis, Acute

Intervention(s)

Drug: Epinephrine

Other: Sterile water

Drug: Indomethacin Rectal Suppository

Primary Outcome(s)

Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition [Time Frame: 7 days]

Secondary Outcome(s)

Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk [Time Frame: 7 days]

Secondary ID(s)

2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors