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

NCT02959112 | Terminated

• 1 other identifier: 2008
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis, Acute

Keywords

pancreatitis after ERCP; epinephrine; papilla; rectal indomethacin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk

  7 days

Study Arms (2)

Epinephrine sprayed on the papilla and rectal indomethacin

ACTIVE COMPARATOR

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

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

Sterile water sprayed on the papilla and rectal indomethacin

PLACEBO COMPARATOR

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

Other: Sterile water; Drug: Indomethacin Rectal Suppository

Interventions

Epinephrine DRUG

Epinephrine sprayed on the papilla and rectal indomethacin

Sterile water OTHER

Epinephrine sprayed on the papilla and rectal indomethacin; Sterile water sprayed on the papilla and rectal indomethacin

Indomethacin Rectal Suppository DRUG

Epinephrine sprayed on the papilla and rectal indomethacin; Sterile water sprayed on the papilla and rectal indomethacin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Tlalpan, 14000, Mexico

Location

Related Publications (1)

• 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.

  PMID: 33558263 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.Sc., Ph. D.

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 8, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)