Back to resultsPrevention of Acute Pancreatitis After Endoscopic Interventions
Primary Purpose
Cholangiolitis, Acute Pancreatitis
Status
Unknown status
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Meksibel
Sponsored by
About this trial
This is an interventional prevention trial for Cholangiolitis focused on measuring Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography
Eligibility Criteria
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.
Sites / Locations
- VSMU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Meksibel
Indometacin
Meloksicam
Oktride
Arm Description
Intravenous 0.1 30 minutes before the procedure and 0.1 once a day for 3 days after the procedure
Into the rectum 1 hour before the procedure and 1 candle 1 time a day for 3 days after the procedure
Intravenous 15 mg 30 minutes before the procedure and 15 mg once a day for 3 days after the procedure
Intravenous 3 ml 30 minutes before the procedure and 3 ml once a day for 3 days after the procedure
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04608760
First Posted
October 24, 2020
Last Updated
November 17, 2020
Sponsor
Vitebsk State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04608760
Brief Title
Prevention of Acute Pancreatitis After Endoscopic Interventions
Official Title
Prevention of Acute Pancreatitis After Endoscopic Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitebsk State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiolitis, Acute Pancreatitis
Keywords
Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meksibel
Arm Type
Active Comparator
Arm Description
Intravenous 0.1 30 minutes before the procedure and 0.1 once a day for 3 days after the procedure
Arm Title
Indometacin
Arm Type
Active Comparator
Arm Description
Into the rectum 1 hour before the procedure and 1 candle 1 time a day for 3 days after the procedure
Arm Title
Meloksicam
Arm Type
Active Comparator
Arm Description
Intravenous 15 mg 30 minutes before the procedure and 15 mg once a day for 3 days after the procedure
Arm Title
Oktride
Arm Type
Active Comparator
Arm Description
Intravenous 3 ml 30 minutes before the procedure and 3 ml once a day for 3 days after the procedure
Intervention Type
Drug
Intervention Name(s)
Meksibel
Intervention Description
2 ml solution
Primary Outcome Measure Information:
Title
Change in the level of inflammation and pain, assessment of severity according to the Ranson scale and Krasnogorov at 1 week
Description
Summ points 0 - pancreatitis, 1 - mild pancreatitis, 2 - severe pancreatitis
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yury Arlouski, MD, PhD
Organizational Affiliation
Vitebsk State Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
VSMU
City
Vitebsk
ZIP/Postal Code
210009
Country
Belarus
12. IPD Sharing Statement
Learn more about this trial
Prevention of Acute Pancreatitis After Endoscopic Interventions
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