Prevention of Acute Pancreatitis After Endoscopic Interventions

Phase 1

• Conditions: Cholangiolitis; Acute Pancreatitis
• Interventions: Drug: Meksibel

• Registration Number: NCT04608760
• Lead Sponsor: Vitebsk State Medical University

Brief 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.

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 Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-10-24
• Study First Submitted QC: 2020-10-24
• Study First Posted: 2020-10-29
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-18
• Primary Completion: 2021-01-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

VSMU; 🇧🇾 Vitebsk, Belarus