Prevention of Acute Pancreatitis After Endoscopic Interventions

Vitebsk State Medical University

Status and phase: Unknown; Phase 1

Conditions: Cholangiolitis; Acute Pancreatitis

Treatments: Drug: Meksibel

Study type: Interventional

Funder types: Other

Identifiers

NCT04608760

Interventional (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 4 patient groups

Meksibel

Active Comparator group

Description:

Intravenous 0.1 30 minutes before the procedure and 0.1 once a day for 3 days after the procedure

Treatment:

Drug: Meksibel

Indometacin

Active Comparator group

Description:

Into the rectum 1 hour before the procedure and 1 candle 1 time a day for 3 days after the procedure

Treatment:

Drug: Meksibel

Meloksicam

Active Comparator group

Description:

Intravenous 15 mg 30 minutes before the procedure and 15 mg once a day for 3 days after the procedure

Treatment:

Drug: Meksibel

Oktride

Active Comparator group

Description:

Intravenous 3 ml 30 minutes before the procedure and 3 ml once a day for 3 days after the procedure

Treatment:

Drug: Meksibel