Prevention of Acute Pancreatitis After Endoscopic Interventions

Sponsor

Vitebsk State Medical University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04608760

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiolitis Acute Pancreatitis	Drug: Meksibel	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Prevention of Acute Pancreatitis After Endoscopic Interventions

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VSMU	Vitebsk		Belarus	210009

Sponsors and Collaborators

Vitebsk State Medical University

Investigators

Study Chair: Yury Arlouski, MD, PhD, Vitebsk State Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vitebsk State Medical University

ClinicalTrials.gov Identifier:

NCT04608760

Other Study ID Numbers:

Interventional

First Posted:

Oct 29, 2020

Last Update Posted:

Nov 18, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vitebsk State Medical University

Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography

Additional relevant MeSH terms:

Pancreatitis

Study Results

No Results Posted as of Nov 18, 2020