Liver CirrhosisNCT05677230
To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt
A study testing Balloon occluded/plug assisted retrograde transvenous obliteration. and Endoscopic Variceal Obturation in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion. Study design: Prospective interventional study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Balloon occluded/plug assisted retrograde transvenous obliteration. and Endoscopic Variceal Obturation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2023to 9 Dec 2024
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Cirrhotic patients, with GV (GOV2 or IGV1) with eradicated or small low risk esophageal varices with gastrorenal shunt of >10 mm size amenable for BRTO/PARTO.
Who cannot join
- Non-cirrhotic portal hypertension,
- History of bleeding from GV
- Hepatic encephalopathy grade III/IV,
- Acute kidney injury
- Patients on beta blocker therapy for > 6 months prior to enrollment in study
- Hepatocellular carcinoma
Show all 11Show fewer
- Portal venous thrombosis
- Presence of jaundice (bilirubin >3 mg/dl), ascites, Child C, MELD > 18
- Advanced cardiac or pulmonary diseases
- Pregnancy
- Patients not giving informed consent
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
Official title: To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt: A Randomized Controlled Trial
Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion.
Study design: Prospective interventional study. The study will be conducted in the Department of Hepatology ILBS.
Study period: 1.0 years
Sample size: 42
- Conditions
- Liver Cirrhosis
- Being tested
- Balloon occluded/plug assisted retrograde transvenous obliteration., Endoscopic Variceal Obturation
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon occluded/plug assisted retrograde transvenous obliteration.Procedure or surgery
Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.
Endoscopic Variceal ObturationProcedure or surgery
Endoscopic Variceal Glue Therapy will be done till obturation every 3 weekly.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Occluded/plug assisted Retrograde Transvenous Obliteration. | Experimental | Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only. Receives: Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration. |
| Endoscopic Variceal Obturation | Active comparator | endoscopic variceal glue therapy will be done till obturation every 3 weekly. Receives: Procedure: Endoscopic Variceal Obturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient having bleeding from GV at 12 months
Measured: 6 months
Secondary outcomes (13)
Proportion of patients achieving complete or partial obturation of GV
Measured: 6 months
Proportion of patients having change in grade of EV and bleeding from EV
Measured: 6 months
Proportion of patients having appearance or worsening of PHG
Measured: 6 months
Change in HVPG in those patients who bleed after BRTO/PRTO
Measured: 6 months
Change in HVPG in those patients who bleed after EVO
Measured: 6 months
Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography
Measured: 6 months
Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography
Measured: 6 months
Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy
Measured: 6 months
Proportion of patient developing post procedure liver failure
Measured: 6 months
Proportion of patient developing post acute kidney injury or sepsis
Measured: 6 months
Duration of hospital stay poof procedure
Measured: 12 months
Evaluation of expertise of endoscopists
Measured: 12 months
Any variceal bleed
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Jan 2023
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT05677230
- Sponsor's protocol ID
- ILBS-Cirrhosis-52
- Status last verified
- Aug 2024
- First submitted
- 3 Jan 2023
- Last updated
- 1 May 2025
- 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05677230
- Acronym / sponsor ID
- ILBS-Cirrhosis-52
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 10 Jan 2023 (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.
Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion.
Study design: Prospective interventional study. The study will be conducted in the Department of Hepatology ILBS.
Study period: 1.0 years
Sample size: 42
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Occluded/plug assisted Retrograde Transvenous Obliteration. | Experimental | Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration.Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only. |
| Endoscopic Variceal Obturation | Active comparator | Procedure: Endoscopic Variceal Obturationendoscopic variceal glue therapy will be done till obturation every 3 weekly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75 years
- Cirrhotic patients, with GV (GOV2 or IGV1) with eradicated or small low risk esophageal varices with gastrorenal shunt of >10 mm size amenable for BRTO/PARTO.
Key exclusion criteria (11 listed)
- Non-cirrhotic portal hypertension,
- History of bleeding from GV
- Hepatic encephalopathy grade III/IV,
- Acute kidney injury
- Patients on beta blocker therapy for > 6 months prior to enrollment in study
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 |
|---|---|---|
| Balloon occluded/plug assisted retrograde transvenous obliteration.Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only. | Procedure or surgery | Balloon Occluded/plug assisted Retrograde Transvenous Obliteration. |
| Endoscopic Variceal ObturationEndoscopic Variceal Glue Therapy will be done till obturation every 3 weekly. | Procedure or surgery | Endoscopic Variceal Obturation |
Primary outcome
Proportion of patient having bleeding from GV at 12 months
Time frame: 6 months
13 secondary outcomes
Proportion of patients achieving complete or partial obturation of GV
Time frame: 6 months
Proportion of patients having change in grade of EV and bleeding from EV
Time frame: 6 months
Proportion of patients having appearance or worsening of PHG
Time frame: 6 months
Change in HVPG in those patients who bleed after BRTO/PRTO
Time frame: 6 months
Change in HVPG in those patients who bleed after EVO
Time frame: 6 months
Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography
Time frame: 6 months
Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography
Time frame: 6 months
Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy
Time frame: 6 months
Proportion of patient developing post procedure liver failure
Time frame: 6 months
Proportion of patient developing post acute kidney injury or sepsis
Time frame: 6 months
Duration of hospital stay poof procedure
Time frame: 12 months
Evaluation of expertise of endoscopists
Time frame: 12 months
Any variceal bleed
Time frame: 12 months
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 1 May 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Balloon occluded/plug assisted retrograde transvenous obliteration. and Endoscopic Variceal Obturation in people with Liver Cirrhosis, 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 2 inclusion and 11 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 1 May 2025. 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?
Proportion of patient having bleeding from GV at 12 months (time frame: 6 months). 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 1 May 2025.