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Prevention of Acute Pancreatitis After Endoscopic Interventions

NCT ID: NCT04608760

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-08-01

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.

Conditions

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Cholangiolitis Acute Pancreatitis

Keywords

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Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Meksibel

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

Group Type ACTIVE_COMPARATOR

Meksibel

Intervention Type DRUG

2 ml solution

Indometacin

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

Group Type ACTIVE_COMPARATOR

Meksibel

Intervention Type DRUG

2 ml solution

Meloksicam

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

Group Type ACTIVE_COMPARATOR

Meksibel

Intervention Type DRUG

2 ml solution

Oktride

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

Group Type ACTIVE_COMPARATOR

Meksibel

Intervention Type DRUG

2 ml solution

Interventions

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Meksibel

2 ml solution

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitebsk State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yury Arlouski, MD, PhD

Role: STUDY_CHAIR

Vitebsk State Medical University

Locations

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VSMU

Vitebsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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Interventional

Identifier Type: -

Identifier Source: org_study_id