Prevention of Acute Pancreatitis After Endoscopic Interventions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Acute Pancreatitis After Endoscopic Interventions

Conditions
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Cholangiolitis, Acute Pancreatitis

Intervention / Treatment
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* Drug: Meksibel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cholangiolithiasis. Patients with benign formations of the bile ducts. Patients with malignant formations of the bile ducts. Patients with extrahepatic bile duct cysts. Patients with biliary hypertension of unknown etiology. Patients with cholangitis. Patients with extrahepatic bile duct strictures. Patients suffering from oncopathology of the head of the pancreas, complicated by obstructive jaundice. Patients with malignant pathology of the pancreas. Patients with benign pancreatic pathology. Exclusion Criteria: ASA scale> III (severe concomitant cardiovascular pathology) Severe pathology of the respiratory system. Acute period of myocardial infarction. Acute period of cerebral infarction.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography