Gastric Varices BleedingBeRTONCT03853720
Combined and Simultaneous Approach for the Treatment of High-risk Gastric Varices Using B-RTO and EVO
A study testing balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices in people with Gastric Varices Bleeding and Gastric Varix, run by Centre Hospitalier Universitaire Vaudois.
Trial summary
The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with balloon occluded-retrograde transvenous obliteration (B-RTO) for the treatment of high-risk gastric varices Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Varices Bleeding, Gastric Varix
- What is being tested?
- balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix "Fiche d'information aux patients et formulaire de consentement éclairé")
- Patients with endoscopically proven high-risk (diameter >2 cm, mosaic gastropathy, red spots or signs of previous bleeding) and GOV2, IGV1 and IGV2 type of gastric varices (according to Sarin classification)
- Portal hypertension secondary to cirrhosis
- Age >18
Who cannot join
- Acute gastric or esophageal varice bleeding
- GOV1 varices according to Sarin classification
- Hemodynamic instability
- Uncompensated cirrhosis
- Contraindication to general anesthesia
- Contraindication to CT-scan/angiography (impaired kidney function, allergy to iodine based contrast)
Show all 10Show fewer
- Allergy to cyanoacrylate, drugs or material used during procedures
- Absence of gastro-renal shunt
- Pregnancy
- Participation to another study involving ionizing radiation (dose superior to 5mSV) without direct benefice for patient during the 12 last months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study Evaluating Efficacy and Safety of Combined and Simultaneous Balloon-occluded Retrograde Transvenous and Endoscopic Obliteration of High-risk Gastric Varices
The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with balloon occluded-retrograde transvenous obliteration (B-RTO) for the treatment of high-risk gastric varices
Read the detailed description
Although less frequent than esophageal varices, gastric varices constitute a severe and potentially life threatening complication of portal hypertension. Various methods have been described to treat gastric varices, including endoscopic and interventional radiology techniques. Endoscopic variceal obliteration (EVO) is currently considered as standard of care for the treatment of gastric varices in most centers. However, this technique is associated with significant rebleeding rates and incomplete obliteration is observed in about 50% of patients. Alternatively, few centers also use an interventional radiology technique, called balloon-occluded retrograde transvenous obliteration (B-RTO) to treat gastric varices, which has been shown to be associated with less recurrence of gastric varices and high rates of eradication of about 90%. Both techniques have their inherent weaknesses, such as frequent incomplete eradication of varices and thromboembolic events for EVO, while data suggest that B-RTO may aggravate esophageal varices.
The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with (modified) B-RTO. Stopping the outflow of gastric varices by endovascular balloon occlusion may allow better endoscopic visualization, blood stagnation and thus eradication of varices, while preventing thromboembolic events. Furthermore, during study follow-up, the eradication rates and recurrence of varices, short-term and long term complications, effects of the procedure on portal pressures/hemodynamics and liver function will be evaluated.
- Conditions
- Gastric Varices Bleeding, Gastric Varix
- Being tested
- balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varicesProcedure or surgery
Catheterization of the left renal vein and the inferior diaphragmatic vein and occlusion with a balloon placed in the distal portion of this vein.
Endoscopic access to the gastric cavity, gastric varices identification and flow measurement, including velocity, by endoscopic Doppler ultrasound (US). The balloon in the draining vein will be inflated and the velocity will be reassessed. Endoscopic puncture of the varices will be done and the embolization will be conducted under balloon-occlusive conditions (Injection of Cyanoacrylate: Lipiodol mixture 1:1 slowly and gradually). Balloon will be kept inflated and a microcatheter will be used through its lumen inside the variceal bed to inject occlusive agent (cyanoacrylate) mixed with Lipiodol.
At the end of the procedure an occlusion device (plug amplatzer 2) will be placed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | combined and simultaneous balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices Receives: Procedure: balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric varice eradication following intervention (at 4 weeks)
Gastric varice eradication following intervention (at 4 weeks) assessed by esophagogastroduodenoscopy (complete eradication or incomplete eradication)
Measured: 4 weeks
Secondary outcomes (8)
Gastric varice eradication following intervention
Gastric varice eradication following intervention (at 12 weeks) assessed by esophagogastroduodenoscopy (complete eradication or incomplete eradication)
Measured: 12 weeks
Recurrence of gastric varices
Recurrence of gastric varices (defined as recurrence of gastric varices after complete eradication (at 4 weeks))
Measured: 4 weeks
Bleeding rates following procedure
Bleeding rates following procedure (% of patients that had a bleeding at 2 years of follow-up following eradication and mean time to bleeding after procedure)
Measured: 2 years
Effect of procedure on esophageal varices
Effect of procedure on esophageal varices. Classification of "Paquet" with evaluation before procedure and at 2 years after procedure (Paquet Grade 1 to 4)
Measured: 2 years
Effect of procedure on portal pressures
Effect of procedure on portal pressures at 3 months assessed by endovascular hepatic pressure measurment (and compared with pressure before procedure).
Measured: 3 months
Effect of procedure on liver function
Effect of procedure on liver function and cirrhosis assessed by CHILD-PUGH score ((albumin (g/l) : >35 = 1 point ; 28-35 = 2 points ; <28 = 3 points); (total bilirubin (umol/l)<34 = 1 point ; 34-50 = 2 points; >50 = 3 points); (INR : <1.7 = 1 point; 1.71-2.30 = 2 points; >2.30 = 3 points), (Ascites: none = 1 point; mild = 2 points, moderate/severe= 3 points); (Hepatic Encephalopathy: none = 1 point; Grade I-II = 2 points; Grade III-IV = 3 points). Total score : 5-6 = A ; 7-9 = B; 10-15 = C.
Measured: 2 years
Description of procedural complications
Description of procedural complications (bleeding, pulmonary embolism)
Measured: 2 years
Description of pre-treatment variceal anatomy/classification
Description of pre-treatment variceal anatomy/classification according to Sarin Classification
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study startApr 2019 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Varices BleedingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alban Denys, Centre Hospitalier Universitaire Vaudois
- Investigators
- Alban Denys, MD, Principal investigator, Full Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853720
- Sponsor's protocol ID
- 2018-02183
- Other IDs
- 2018
- Acronym
- BeRTO
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Efficacy and Safety of Combined and Simultaneous Balloon-occluded Retrograde Transvenous and Endoscopic Obliteration of High-risk Gastric Varices
- ClinicalTrials.gov ID
- NCT03853720
- Acronym / sponsor ID
- BeRTO / 2018-02183
- Conditions
- Gastric Varices Bleeding, Gastric Varix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 26 Feb 2019 (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 this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with balloon occluded-retrograde transvenous obliteration (B-RTO) for the treatment of high-risk gastric varices
Detailed description
Although less frequent than esophageal varices, gastric varices constitute a severe and potentially life threatening complication of portal hypertension. Various methods have been described to treat gastric varices, including endoscopic and interventional radiology techniques. Endoscopic variceal obliteration (EVO) is currently considered as standard of care for the treatment of gastric varices in most centers. However, this technique is associated with significant rebleeding rates and incomplete obliteration is observed in about 50% of patients. Alternatively, few centers also use an interventional radiology technique, called balloon-occluded retrograde transvenous obliteration (B-RTO) to treat gastric varices, which has been shown to be associated with less recurrence of gastric varices and high rates of eradication of about 90%. Both techniques have their inherent weaknesses, such as frequent incomplete eradication of varices and thromboembolic events for EVO, while data suggest that B-RTO may aggravate esophageal varices.
The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with (modified) B-RTO. Stopping the outflow of gastric varices by endovascular balloon occlusion may allow better endoscopic visualization, blood stagnation and thus eradication of varices, while preventing thromboembolic events. Furthermore, during study follow-up, the eradication rates and recurrence of varices, short-term and long term complications, effects of the procedure on portal pressures/hemodynamics and liver function will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Procedure: balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varicescombined and simultaneous balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent as documented by signature (Appendix "Fiche d'information aux patients et formulaire de consentement éclairé")
- Patients with endoscopically proven high-risk (diameter >2 cm, mosaic gastropathy, red spots or signs of previous bleeding) and GOV2, IGV1 and IGV2 type of gastric varices (according to Sarin classification)
- Portal hypertension secondary to cirrhosis
- Age >18
Key exclusion criteria (10 listed)
- Acute gastric or esophageal varice bleeding
- GOV1 varices according to Sarin classification
- Hemodynamic instability
- Uncompensated cirrhosis
- Contraindication to general anesthesia
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 retrograde transvenous and endoscopic obliteration of high-risk gastric varicesCatheterization of the left renal vein and the inferior diaphragmatic vein and occlusion with a balloon placed in the distal portion of this vein. Endoscopic access to the gastric cavity, gastric varices identification and flow measurement, including velocity, by endoscopic Doppler ultrasound (US). The balloon in the draining vein will be inflated and the velocity will be reassessed. Endoscopic puncture of the varices will be done and the embolization will be conducted under balloon-occlusive conditions (Injection of Cyanoacrylate: Lipiodol mixture 1:1 slowly and gradually). Balloon will be kept inflated and a microcatheter will be used through its lumen inside the variceal bed to inject occlusive agent (cyanoacrylate) mixed with Lipiodol. At the end of the procedure an occlusion device (plug amplatzer 2) will be placed. | Procedure or surgery | Intervention arm |
Primary outcome
Gastric varice eradication following intervention (at 4 weeks)
Time frame: 4 weeks
Gastric varice eradication following intervention (at 4 weeks) assessed by esophagogastroduodenoscopy (complete eradication or incomplete eradication)
8 secondary outcomes
Gastric varice eradication following intervention
Time frame: 12 weeks
Recurrence of gastric varices
Time frame: 4 weeks
Bleeding rates following procedure
Time frame: 2 years
Effect of procedure on esophageal varices
Time frame: 2 years
Effect of procedure on portal pressures
Time frame: 3 months
Effect of procedure on liver function
Time frame: 2 years
Description of procedural complications
Time frame: 2 years
Description of pre-treatment variceal anatomy/classification
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Gastric Varices Bleeding
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Recruiting
EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis
Gastric Varices Bleeding, Cirrhosis
Not yet recruiting
Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Gastric Varices
Gastric Varices Bleeding, Gastric Varices
Not yet recruiting
Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial
Gastric Varices
Not yet recruiting
Mesenteric Vein Access for OPVT-Related Recurrent Variceal Bleeding: An Ambispective Cohort
Occlusive Portal Vein Thrombosis (OPVT), Cavernous Transformation of Portal Vein
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.
Alban Denys, MD principal investigator
Full Professor
Questions about this trial
What is this clinical trial studying?
A study testing balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices in people with Gastric Varices Bleeding and Gastric Varix, run by Centre Hospitalier Universitaire Vaudois.
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 4 inclusion and 10 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alban Denys, MD (0041213149768, alban.denys@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric varice eradication following intervention (at 4 weeks) (time frame: 4 weeks). 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 26 Feb 2019.