Study of drug (epinephrine spray on papilla) to prevent pancreatitis resulting from Endoscopic retrograde cholangiopancreatography procedure.
Not Applicable
Completed
- 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.
- Registration Number
- CTRI/2018/04/013396
- Lead Sponsor
- Department of Gastroenterology Sherikashmir Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 997
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
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 )
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>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 Outcome Measures
Name Time Method 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.