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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Terminated

Conditions: Pancreatitis, Acute

Treatments: Drug: Indomethacin Rectal Suppository; Drug: Epinephrine; Other: Sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT02959112

2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 548 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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548 participants in 2 patient groups, including a placebo group

Epinephrine sprayed on the papilla and rectal indomethacin

Active Comparator group

Description:

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

Treatment:

Drug: Epinephrine

Drug: Indomethacin Rectal Suppository

Other: Sterile water

Sterile water sprayed on the papilla and rectal indomethacin

Placebo Comparator group

Description:

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

Treatment:

Drug: Indomethacin Rectal Suppository

Other: Sterile water