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Study of drug (epinephrine spray on papilla) to prevent pancreatitis resulting from Endoscopic retrograde cholangiopancreatography procedure.

Role of epinephrine spray on papilla for prevention and prophylaxis of post ERCP Pancreatitis. - POEP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013396
Enrollment
400
Registered
2018-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- 400 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited for the study.

Interventions

Intervention1: Experimental: Drug: epinephrine 20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla: Drug: epinephrine 20-mL irrigation with epinephrine diluted to 0.02

Sponsors

Department of Gastroenterology Sherikashmir Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18 years 2.Both males and females 3.Signed consent and agreed to have proper follow-up as advised.

Exclusion criteria

Exclusion criteria: 1. Acute / chronic pancreatitis. 2. Pregnancy 3. Allergy / contraindications to epinephrine. 4. Psychological or medical conditions that would not permit the patient to complete the study or sign the consent form. 5. Billroth II or Roux-en-Y anatomy. 6. chronic renal disease ( creatinine > 1.5 mg/dl )

Design outcomes

Primary

MeasureTime frame
The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis [ Time Frame: PEP occurence rate at 24 h after ERCP in two groups. If the serum amylase is 3 times higher than the normal values after 24 hours of ERCP in patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis).Timepoint: at 3 hours after ERCP, serum amylase will be done and at 24 hours after ERCP, serum amylase will be done again along with ultrasonography of abdomen.

Secondary

MeasureTime frame
Compare epinephrine group with control group on the incidence of hyperamylasemia/adverse events.Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms. During the study, any unexpected medical issue will be called adverse event.Timepoint: at 3 hours and at 24 hours after ERCP, serum amylase will be done.

Countries

India

Contacts

Public ContactHilal Ahmad Dar

Sher-i-kashmir Institute of Medical Sciences,srinagar kashmir.

guljavid@rediffmail.com9419057093

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 21, 2026