Prevention of Acute Pancreatitis After Endoscopic Interventions

NCT04608760 | Unknown Phase 1

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiolitis; Acute Pancreatitis

Keywords

Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Meksibel

ACTIVE COMPARATOR

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

Drug: Meksibel

Indometacin

ACTIVE COMPARATOR

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

Drug: Meksibel

Meloksicam

ACTIVE COMPARATOR

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

Drug: Meksibel

Oktride

ACTIVE COMPARATOR

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

Drug: Meksibel

Interventions

Meksibel DRUG

2 ml solution

Indometacin; Meksibel; Meloksicam; Oktride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ASA scale\> III (severe concomitant cardiovascular pathology)
• Severe pathology of the respiratory system.
• Acute period of myocardial infarction.
• Acute period of cerebral infarction.

Sponsors & Collaborators

• Vitebsk State Medical University: lead

Study Sites (1)

VSMU

Vitebsk, 210009, Belarus

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Yury Arlouski, MD, PhD

  Vitebsk State Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: October 29, 2020
• Study Start: August 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

BE (1)