Budd-Chiari SyndromeNCT05117684
To Compare "Balloon Occluded Thrombolysis" With "Conventional Catheter Directed Thrombolysis" in Thrombotically Occluded DIPSS Stent in Patients of Budd- Chiari Syndrome.
An observational study of Budd-Chiari Syndrome, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
DIPSS has become a widely accepted treatment for complications of portal hypertension. Shunt or hepatic vein stenosis are common short and mid term complications of the procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Budd-Chiari Syndrome
- What is being tested?
- Novel and Conventional
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteIndia
- Study dates
- 5 Nov 2021to 20 Dec 2021
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Budd -Chiari syndrome who underwent DIPSS revision till February 2021
Who may be able to join
- Patients of Budd- Chiari syndrome who underwent DIPSS revision for blocked stent till February 2021
Who cannot join
- Patients who underwent DIPSS revision more than one time using both the techniques were excluded.
- Failure to cannulate existing shunt.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
DIPSS has become a widely accepted treatment for complications of portal hypertension. Shunt or hepatic vein stenosis are common short and mid term complications of the procedure. When identified early, shunt stenosis or occlusion may be treated before recurrence of the symptoms for which DIPSS was done at the first place. Present day endovascular DIPSS revision techniques have significantly improved the primary assisted patency rates.
The purpose of this study is to understand the newer technique of Combined balloon occlusion thrombolysis and intra stent balloon sweeping being practiced at our institute and compare it with the widely used conventional thrombolytic methods.
Read the detailed description
Primary objective:
- To study the outcome of combined technique of Balloon occluded thrombolysis, Balloon sweeping and maceration of thrombus in Blocked DIPSS stent and compare it with Conventional catheter directed thrombolysis and angioplasty. Secondary objective:
- Study DIPSS stent patency and re-occlusion rates at 1 month followup
Methodology:
Study population: Patients with Budd -Chiari syndrome who underwent DIPSS revision till February 2021
Study design: Single center retrospective cohort study
Study period: 1year
Sample size: All eligible patients according to inclusion and exclusion criteria who underwent TIPS/DIPS revision will be included in thestudy.
Intervention: DIPSS Revision
Monitoring andassessment:
The following parameters to be evaluated over a period at least 1 month after DIPSS revision and compare with pre revisionvalues
Clinical parameters:
Status of ascites Urine output Recurrence of UGI/LGI bleed
Laboratory parameters:
ALBI Score,LFT, KFT
DOPPLER PARAMETERS:
Mid stent velocity, velocity at hepatic venous end Main portal vein velocity Direction of flow in intrahepatic portal vein branches
Stopping rule: Not applicable.
Expected outcome of the project: Balloon Occluded thrombolytic infusion alongwith intratsent balloon sweeping gives faster and better patency as compared to conventional pharmaco-mechanicalthrombolytic methods
- Conditions
- Budd-Chiari Syndrome
- Being tested
- Novel, Conventional
- Medical subject headings
- Budd-Chiari Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovelProcedure or surgery
Balloon- Occlusion thrombolysis was done in adjunct to thrombus maceration, balloon sweeping and thrombosuction.
ConventionalProcedure or surgery
Continuous catheter directed thrombolysis (Continuous urokinase infusion) was done along with thrombus maceration, balloon sweeping and thrombosuction.
| Study group | Role | What they receive |
|---|---|---|
| Novel | Balloon- Occlusion thrombolysis was done in adjunct to thrombus maceration, balloon sweeping and thrombosuction. Receives: Procedure: Novel | |
| Conventional | Continuous catheter directed thrombolysis (Continuous urokinase infusion) was done along with thrombus maceration, balloon sweeping and thrombosuction. Receives: Procedure: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the rate of re-stenting between the two groups
Measured: Day 0
Compare the mean total dose of thrombolytic drug administered between the two groups
Measured: Day 0
Secondary outcomes (2)
Study DIPSS stent patency and re-occlusion rates at 1 month followup.
Measured: 1 month
To compare the length of hospital stay between two groups
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start5 Nov 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Budd-Chiari SyndromeStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117684
- Sponsor's protocol ID
- ILBS-Budd-Chiari-01
- Status last verified
- Dec 2021
- First submitted
- 30 Oct 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare "Balloon Occluded Thrombolysis" With "Conventional Catheter Directed Thrombolysis" in Thrombotically Occluded DIPSS Stent in Patients of Budd- Chiari Syndrome.
- ClinicalTrials.gov ID
- NCT05117684
- Acronym / sponsor ID
- ILBS-Budd-Chiari-01
- Conditions
- Budd-Chiari Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 11 Nov 2021 (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.
DIPSS has become a widely accepted treatment for complications of portal hypertension. Shunt or hepatic vein stenosis are common short and mid term complications of the procedure. When identified early, shunt stenosis or occlusion may be treated before recurrence of the symptoms for which DIPSS was done at the first place. Present day endovascular DIPSS revision techniques have significantly improved the primary assisted patency rates.
The purpose of this study is to understand the newer technique of Combined balloon occlusion thrombolysis and intra stent balloon sweeping being practiced at our institute and compare it with the widely used conventional thrombolytic methods.
Detailed description
Primary objective:
- To study the outcome of combined technique of Balloon occluded thrombolysis, Balloon sweeping and maceration of thrombus in Blocked DIPSS stent and compare it with Conventional catheter directed thrombolysis and angioplasty. Secondary objective:
- Study DIPSS stent patency and re-occlusion rates at 1 month followup
Methodology:
Study population: Patients with Budd -Chiari syndrome who underwent DIPSS revision till February 2021
Study design: Single center retrospective cohort study
Study period: 1year
Sample size: All eligible patients according to inclusion and exclusion criteria who underwent TIPS/DIPS revision will be included in thestudy.
Intervention: DIPSS Revision
Monitoring andassessment:
The following parameters to be evaluated over a period at least 1 month after DIPSS revision and compare with pre revisionvalues
Clinical parameters:
Status of ascites Urine output Recurrence of UGI/LGI bleed
Laboratory parameters:
ALBI Score,LFT, KFT
DOPPLER PARAMETERS:
Mid stent velocity, velocity at hepatic venous end Main portal vein velocity Direction of flow in intrahepatic portal vein branches
Stopping rule: Not applicable.
Expected outcome of the project: Balloon Occluded thrombolytic infusion alongwith intratsent balloon sweeping gives faster and better patency as compared to conventional pharmaco-mechanicalthrombolytic methods
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel | – | Procedure: NovelBalloon- Occlusion thrombolysis was done in adjunct to thrombus maceration, balloon sweeping and thrombosuction. |
| Conventional | – | Procedure: ConventionalContinuous catheter directed thrombolysis (Continuous urokinase infusion) was done along with thrombus maceration, balloon sweeping and thrombosuction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Budd -Chiari syndrome who underwent DIPSS revision till February 2021
Key inclusion criteria (1 listed)
- Patients of Budd- Chiari syndrome who underwent DIPSS revision for blocked stent till February 2021
Key exclusion criteria (2 listed)
- Patients who underwent DIPSS revision more than one time using both the techniques were excluded.
- Failure to cannulate existing shunt.
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 |
|---|---|---|
| NovelBalloon- Occlusion thrombolysis was done in adjunct to thrombus maceration, balloon sweeping and thrombosuction. | Procedure or surgery | Novel |
| ConventionalContinuous catheter directed thrombolysis (Continuous urokinase infusion) was done along with thrombus maceration, balloon sweeping and thrombosuction. | Procedure or surgery | Conventional |
Primary outcome
Compare the rate of re-stenting between the two groups
Time frame: Day 0
Compare the mean total dose of thrombolytic drug administered between the two groups
Time frame: Day 0
2 secondary outcomes
Study DIPSS stent patency and re-occlusion rates at 1 month followup.
Time frame: 1 month
To compare the length of hospital stay between two groups
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Budd-Chiari Syndrome
RecruitingObservational study
Freiburg TIPS Registry
Liver Cirrhosis, Portal Hypertension
Not yet recruiting
A Prospective Study on IVUS and DSA Guidance in the Treatment of Budd-Chiari Syndrome
Budd-Chiari Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Budd-Chiari Syndrome, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Dec 2021. 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 India. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the rate of re-stenting between the two groups (time frame: Day 0). The study lists 2 primary outcomes in all. 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 27 Dec 2021.