Clinical trial NCT02959112: Epinephrine Sprayed on the Papilla Versus Sterile Water Sprayed on the Papilla for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatitis, Acute
Keywords: pancreatitis after ERCP
epinephrine
papilla
rectal indomethacin
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition
timeFrame: 7 days
Secondary outcomes:
measure: Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk
timeFrame: 7 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: Tlalpan
Study officials:
References:
citation: Romano-Munive AF, Garcia-Correa JJ, Garcia-Contreras LF, Ramirez-Garcia J, Uscanga L, Barbero-Becerra VJ, Moctezuma-Velazquez C, Ochoa-Rubi JA, Toledo-Cuque J, Vazquez-Anaya G, Keil-Rios D, Grajales-Figueroa G, Ramirez-Luna MA, Valdovinos-Andraca F, Zamora-Nava LE, Tellez-Avila F. Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial. BMJ Open Gastroenterol. 2021 Feb;8(1):e000562. doi: 10.1136/bmjgast-2020-000562.