CholangiolitisPhase 1NCT04608760
Prevention of Acute Pancreatitis After Endoscopic Interventions
A Phase 1 study testing Meksibel in people with Cholangiolitis and Acute Pancreatitis, run by Vitebsk State Medical University at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiolitis, Acute Pancreatitis
- What is being tested?
- Meksibel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Aug 2020to 1 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- ASA scale> III (severe concomitant cardiovascular pathology)
- Severe pathology of the respiratory system.
- Acute period of myocardial infarction.
- Acute period of cerebral infarction.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cholangiolitis, Acute Pancreatitis
- Being tested
- Meksibel
- Keywords
- Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeksibelDrug
2 ml solution
| Study group | Role | What they receive |
|---|---|---|
| Meksibel | Active comparator | Intravenous 0.1 30 minutes before the procedure and 0.1 once a day for 3 days after the procedure Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Meksibel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Aug 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitebsk State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yury Arlouski, MD, PhD, Study chair, Vitebsk State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608760
- Sponsor's protocol ID
- Interventional
- Status last verified
- Nov 2020
- First submitted
- 24 Oct 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Acute Pancreatitis After Endoscopic Interventions
- ClinicalTrials.gov ID
- NCT04608760
- Acronym / sponsor ID
- Interventional
- Conditions
- Cholangiolitis, Acute Pancreatitis
- Keywords
- Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vitebsk State Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Meksibel | Active comparator | Drug: MeksibelIntravenous 0.1 30 minutes before the procedure and 0.1 once a day for 3 days after the procedure |
| Indometacin | Active comparator | Drug: MeksibelInto the rectum 1 hour before the procedure and 1 candle 1 time a day for 3 days after the procedure |
| Meloksicam | Active comparator | Drug: MeksibelIntravenous 15 mg 30 minutes before the procedure and 15 mg once a day for 3 days after the procedure |
| Oktride | Active comparator | Drug: MeksibelIntravenous 3 ml 30 minutes before the procedure and 3 ml once a day for 3 days after the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- ASA scale> III (severe concomitant cardiovascular pathology)
- Severe pathology of the respiratory system.
- Acute period of myocardial infarction.
- Acute period of cerebral infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meksibel2 ml solution | Drug | Indometacin, Meksibel, Meloksicam, Oktride |
Primary outcome
Change in the level of inflammation and pain, assessment of severity according to the Ranson scale and Krasnogorov at 1 week
Time frame: 1 week
Summ points 0 - pancreatitis, 1 - mild pancreatitis, 2 - severe pancreatitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yury Arlouski, MD, PhD study chair
Vitebsk State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meksibel in people with Cholangiolitis and Acute Pancreatitis, run by Vitebsk State Medical University at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of inflammation and pain, assessment of severity according to the Ranson scale and Krasnogorov at 1 week (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.