Epinephrine Sprayed on the Papilla Versus Sterile Water Sprayed on the Papilla for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography
- Conditions
- Pancreatitis, Acute
- Interventions
- Registration Number
- NCT02959112
- Lead Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Brief Summary
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.
- Detailed Description
This multicentre randomised placebo-controlled trial was conducted in two hospitals in Mexico: the National Institute of Medical Sciences and Nutrition "Salvador Zubirán" (INCMNSZ) in Mexico City, and Bernardette Hospital in Jalisco. The study was approved by both institutional review boards. All patients provided written informed consent.
All patients were given a dose of rectal indomethacin (100 mg) at the beginning of the ERCP. Depending on the experimental group, either 10 ml of sterile water or 10 ml of a 1:10,000 epinephrine dilution (0.1 mg/ml) was sprayed on the ampulla through a biliary balloon or a sphincterotome, avoiding any direct contact with the papilla during irrigation at the end of the procedure.
After the procedure, patients were monitored in the recovery room for 2 hours and then discharged. Symptoms of acute pancreatitis or any other complication were interrogated at baseline while in the recovery room, and then by telephone 24 hours and 7 days after the procedure. Serum levels of pancreatic enzymes were determined only if the patient developed abdominal pain after ERCP.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 548
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sterile water sprayed on the papilla and rectal indomethacin Indomethacin Rectal Suppository 10 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure Epinephrine sprayed on the papilla and rectal indomethacin Indomethacin Rectal Suppository Epinephrine 1 mg/1 mL + 9 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure Epinephrine sprayed on the papilla and rectal indomethacin Sterile water Epinephrine 1 mg/1 mL + 9 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure Sterile water sprayed on the papilla and rectal indomethacin Sterile water 10 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure Epinephrine sprayed on the papilla and rectal indomethacin Epinephrine Epinephrine 1 mg/1 mL + 9 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure
- Primary Outcome Measures
Name Time Method Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition 7 days 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
- Secondary Outcome Measures
Name Time Method Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk 7 days
Trial Locations
- Locations (1)
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
🇲🇽Mexico City, Tlalpan, Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán🇲🇽Mexico City, Tlalpan, Mexico