Prevention of Acute Pancreatitis After Endoscopic Interventions

Overview

The aim of the study is to develop a method for the prevention of acute pancreatitis after minimally invasive interventions of the bile ducts using a drug regimen.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 1, 2021

Detailed Description

A prospective, randomized, single-center study is planned to identify the most effective drug regimen in order to prevent the development of acute pancreatitis after transpapillary interventions of the bile ducts.

Interventions

  • Drug: Meksibel
    • 2 ml solution

Arms, Groups and Cohorts

  • Active Comparator: Meksibel
    • Intravenous 0.1 30 minutes before the procedure and 0.1 once a day for 3 days after the procedure
  • Active Comparator: Indometacin
    • Into the rectum 1 hour before the procedure and 1 candle 1 time a day for 3 days after the procedure
  • Active Comparator: Meloksicam
    • Intravenous 15 mg 30 minutes before the procedure and 15 mg once a day for 3 days after the procedure
  • Active Comparator: Oktride
    • Intravenous 3 ml 30 minutes before the procedure and 3 ml once a day for 3 days after the procedure

Clinical Trial Outcome Measures

Primary Measures

  • Change in the level of inflammation and pain, assessment of severity according to the Ranson scale and Krasnogorov at 1 week
    • Time Frame: 1 week
    • Summ points 0 – pancreatitis, 1 – mild pancreatitis, 2 – severe pancreatitis

Participating in This Clinical Trial

Inclusion Criteria

1. Patients with cholangiolithiasis. 2. Patients with benign formations of the bile ducts. 3. Patients with malignant formations of the bile ducts. 4. Patients with extrahepatic bile duct cysts. 5. Patients with biliary hypertension of unknown etiology. 6. Patients with cholangitis. 7. Patients with extrahepatic bile duct strictures. 8. Patients suffering from oncopathology of the head of the pancreas, complicated by obstructive jaundice. 9. Patients with malignant pathology of the pancreas. 10. Patients with benign pancreatic pathology. Exclusion Criteria:

1. ASA scale> III (severe concomitant cardiovascular pathology) 2. Severe pathology of the respiratory system. 3. Acute period of myocardial infarction. 4. Acute period of cerebral infarction.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vitebsk State Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yury Arlouski, MD, PhD, Study Chair, Vitebsk State Medical University

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