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

Pancreatitis, Acute Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02959112
• Other study ID #: 2008
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 2019

Study information

• Verified date: February 2020
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 548
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute

Intervention

Drug:
• Epinephrine

Other:
• Sterile water

Drug:
• Indomethacin Rectal Suppository

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition	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	7 days
Secondary	Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk		7 days