Pancreatitis, Acute
Conditions
Keywords
pancreatitis after ERCP, epinephrine, papilla, rectal indomethacin
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.
Interventions
DRUGEpinephrine
OTHERSterile water
DRUGIndomethacin Rectal Suppository
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
As the two solutions are colourless, the endoscopist, nurse and patient were all blinded to the intervention. Investigators who participated in the evaluation of post-ERCP complications were also blinded to group allocation.
Intervention model description
Participants were allocated into groups by block randomisation using computed-generated numbers. The two groups were rectal indomethacin and epinephrine sprayed on the ampulla versus rectal indomethacin and sham water spray.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk | 7 days |
Countries
Mexico
Outcome results
None listed