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
• Status: Enrolling by invitation
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Cholangiolitis
• Pancreatitis

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