Prevention of Acute Pancreatitis After Endoscopic Interventions

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 Overview

• Status: Unknown
• Conditions: Acute Pancreatitis; Cholangiolitis
• Intervention / Treatment: Drug: Meksibel

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belarus
  • Vitebsk, Belarus, 210009
    • VSMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Meksibel; Intravenous 0.1 30 minutes before the procedure and 0.1 once a day for 3 days after the procedure	Drug: Meksibel; 2 ml solution
Active Comparator: Indometacin; Into the rectum 1 hour before the procedure and 1 candle 1 time a day for 3 days after the procedure	Drug: Meksibel; 2 ml solution
Active Comparator: Meloksicam; Intravenous 15 mg 30 minutes before the procedure and 15 mg once a day for 3 days after the procedure	Drug: Meksibel; 2 ml solution
Active Comparator: Oktride; Intravenous 3 ml 30 minutes before the procedure and 3 ml once a day for 3 days after the procedure	Drug: Meksibel; 2 ml solution

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vitebsk State Medical University
• Investigators: Study Chair: Yury Arlouski, MD, PhD, Vitebsk State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: October 24, 2020
• First Submitted That Met QC Criteria: October 24, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No