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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

548 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatitis, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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Epinephrine sprayed on the papilla and rectal indomethacin

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

Group Type ACTIVE_COMPARATOR

Epinephrine

Intervention Type DRUG

Sterile water

Intervention Type OTHER

Indomethacin Rectal Suppository

Intervention Type DRUG

Sterile water sprayed on the papilla and rectal indomethacin

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

Group Type PLACEBO_COMPARATOR

Sterile water

Intervention Type OTHER

Indomethacin Rectal Suppository

Intervention Type DRUG

Interventions

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Epinephrine

Intervention Type DRUG

Sterile water

Intervention Type OTHER

Indomethacin Rectal Suppository

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No