Prevention of Acute Pancreatitis After Endoscopic Interventions

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04608760

Enrollment

Registered

2020-10-29

Start date

2020-08-01

Completion date

2021-08-01

Last updated

2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis, Cholangiolitis

Keywords

Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography

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.

Interventions

DRUGMeksibel

2 ml solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026