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NCT04608760 Clinical Trial

Prevention of Acute Pancreatitis After Endoscopic Interventions

Acute Pancreatitis Clinical Trial

Official title:
Prevention of Acute Pancreatitis After Endoscopic Interventions

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04608760
Other study ID # Interventional
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date August 1, 2020
Est. completion date August 1, 2021

Study information
Verified date November 2020
Source Vitebsk State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 90
Est. completion date August 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Meksibel
2 ml solution

Locations
Country Name City State
Belarus VSMU Vitebsk

Sponsors (1)
Lead Sponsor Collaborator
Vitebsk State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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