Gastric VarixNCT05500625
Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices
A study testing Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection and Ballon-occluded retrograde transvenous obliteration in people with Gastric Varix, run by Assiut University.
Trial summary
Gastrointestinal bleeding is a common complication of liver cirrhosis which caused by esophageal and gastric varices. The risk of bleeding from gastric varices is relatively low. However, the bleeding is usually significant and severe. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Varix
- What is being tested?
- Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection and Ballon-occluded retrograde transvenous obliteration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2022to 30 Jan 2025
- 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
- Presence of fundal gastric varices either: High risk for rupture; diagnosed by upper endoscopy i.e. large size or presence of red color spot.
- Bleeding varices; diagnosed by upper endoscopy with good hemostasis achieved with endoscopic treatment.
- Bleeding varices; diagnosed by upper endoscopy but hemostasis could not be achieved with endoscopic treatment.
- Fundal gastric varices with Presence of contraindication for TIPS such as repeated attacks of hepatic encephalopathy due to Portosystemic shunt, Model of End Stage Liver disease score (MELD) >18.
- Fundal varices with catheterizable portosystemic shunt such as gastrorenal shunt or gastrocaval shunt.
Who cannot join
- Complete portal vein thrombosis
- Splenic vein thrombosis
- Intractable ascites (TIPS is better)
- Uncontrolled esophageal varices (high risk for bleeding) and TIPS is better
Trial locations and contacts
No sites are listed yet.
About this study
Gastrointestinal bleeding is a common complication of liver cirrhosis which caused by esophageal and gastric varices. The risk of bleeding from gastric varices is relatively low. However, the bleeding is usually significant and severe.
Current guidelines recommend endoscopic glue injection as the first line of treatment for gastric variceal bleeding.
Read more
Although this technique has been shown to be effective, it is associated with many severe adverse events including systemic embolization, fever, chest pain, and even death. The rate of hemostasis has been reported to be as high as 91-100% but the rebleeding rate from gastric varices still present.
Endoscopic ultrasound (EUS) guided therapy has recently been introduced as a more effective and safer option than endoscopic therapy for gastric varices. EUS-guided therapy includes EUS guided Cyanoacrylate injection alone or in combination with EUS-guided coiling. It offers the advantage of directly visualizing the varices and delivering targeted therapy.
A standard endoscopic examination only allows the evaluation of superficial varices. The use of Endoscopic ultrasound facilitates evaluation of peri-gastric and perforating vessels, which are directly involved in variceal development. EUS also facilitates accurate placement of the coil and preserves the naturally formed splenorenal shunt.
Balloon-occluded retrograde transvenous obliteration(BRTO) has been reported to achieve satisfactory bleeding control rates for isolated gastric varices with High hemostasis rates and low rebleeding rate.
Despite all these promising results, there are scarce studies describing and comparing the efficacy of EUS-guided therapy and BRTO in patients with gastric varices. Further prospective comparative studies are needed.
- Conditions
- Gastric Varix
- Being tested
- Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection, Ballon-occluded retrograde transvenous obliteration
- 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.
Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injectionProcedure or surgery
Also called EUS-guided coil embolization combined with endoscopic cyanoacrylate injection
Standard diagnostic endoscopy will be done and Fundal varices will be assessed. EUS procedures will be performed using linear endoscope under general anesthesia. Use EUS to assess the anatomy of gastric varices, observe the blood flow, scan the portal venous system, left renal vein, confirm the location of the shunt, and measure the diameter of the shunt. Puncture the gastric fundal variceal vein at the lower esophagus near the cardia and place the coil into the shunt and immediately inject with sclerosant and cyanoacrylate under the guidance of EUS using a sandwich method (cyanoacrylate, sclerosant and cyanoacrylate) via endoscope. Use color Doppler ultrasound to observe the blood flow in the variceal veins to evaluate the embolization effect.
Ballon-occluded retrograde transvenous obliterationProcedure or surgery
Also called BRTO
A balloon occlusion catheter will be inserted into the venous end of the gastro-renal or gastro-caval shunt via the right femoral vein or internal jugular vein. Balloon-occluded retrograde venogram will be done to evaluate degree of retrograde filling of the gastric varices and presence of collateral veins. Any significant large collateral veins seen will be occluded with coils using microcatheter to prevent leakage of the sclerosant into the systemic circulation. Then, sclerosant agent (ethanol-amine oleate, Sodium tetradecyl sulphate, or polidocanol) will be injected into the portosystemic shunt till complete filling of the gastric varices and part of the feeding veins. Finally, the balloon left in place for 2-12 hours then gradually will be deflated when complete occlusion of blood flow of the target shunt is achieved.
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided coil embolization combined with endoscopic cyanoacrylate injection | Experimental | Not described Receives: Procedure: Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection |
| Ballon-occluded retrograde transvenous obliteration | Experimental | Not described Receives: Procedure: Ballon-occluded retrograde transvenous obliteration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric varices bleeding control
Teatment using EUS- guided coil with cyanoacrylate injection in group of patients and other group treatment using Balloon-Occluded Retrograde Transvenous Obliteration Gastric varices bleeding control within 1 week The parameter will be assesed is incidence of bleeding after the procedure number of attacks of haematemsis and melena)
Measured: 7 days
Time of procedure
Time of the whole procedure of EUS and BRTO
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 posted15 Aug 2022
- Study start30 Aug 2022 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric VarixStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohammed Mahrous Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500625
- Sponsor's protocol ID
- EUSCCIBRTOMPGV
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boregowda U, Umapathy C, Halim N, Desai M, Nanjappa A, Arekapudi S, Theethira T, Wong H, Roytman M, Saligram S. Update on the management of gastrointestinal varices. World J Gastrointest Pharmacol Ther. 2019 Jan 21;10(1):1-21. doi: 10.4292/wjgpt.v10.i1.1.
PubMed 30697445Baig M, Ramchandani M, Puli SR. Safety and efficacy of endoscopic ultrasound-guided combination therapy for treatment of gastric varices: a systematic review and meta-analysis. Clin J Gastroenterol. 2022 Apr;15(2):310-319. doi: 10.1007/s12328-022-01600-0. Epub 2022 Feb 8.
PubMed 35133625
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices
- ClinicalTrials.gov ID
- NCT05500625
- Acronym / sponsor ID
- EUSCCIBRTOMPGV
- Conditions
- Gastric Varix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Aug 2022 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 15 Aug 2022 (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.
Gastrointestinal bleeding is a common complication of liver cirrhosis which caused by esophageal and gastric varices. The risk of bleeding from gastric varices is relatively low. However, the bleeding is usually significant and severe.
Current guidelines recommend endoscopic glue injection as the first line of treatment for gastric variceal bleeding.
Although this technique has been shown to be effective, it is associated with many severe adverse events including systemic embolization, fever, chest pain, and even death. The rate of hemostasis has been reported to be as high as 91-100% but the rebleeding rate from gastric varices still present.
Endoscopic ultrasound (EUS) guided therapy has recently been introduced as a more effective and safer option than endoscopic therapy for gastric varices. EUS-guided therapy includes EUS guided Cyanoacrylate injection alone or in combination with EUS-guided coiling. It offers the advantage of directly visualizing the varices and delivering targeted therapy.
A standard endoscopic examination only allows the evaluation of superficial varices. The use of Endoscopic ultrasound facilitates evaluation of peri-gastric and perforating vessels, which are directly involved in variceal development. EUS also facilitates accurate placement of the coil and preserves the naturally formed splenorenal shunt.
Balloon-occluded retrograde transvenous obliteration(BRTO) has been reported to achieve satisfactory bleeding control rates for isolated gastric varices with High hemostasis rates and low rebleeding rate.
Despite all these promising results, there are scarce studies describing and comparing the efficacy of EUS-guided therapy and BRTO in patients with gastric varices. Further prospective comparative studies are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-guided coil embolization combined with endoscopic cyanoacrylate injection | Experimental | Procedure: Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection |
| Ballon-occluded retrograde transvenous obliteration | Experimental | Procedure: Ballon-occluded retrograde transvenous obliteration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of fundal gastric varices either: High risk for rupture; diagnosed by upper endoscopy i.e. large size or presence of red color spot.
- Bleeding varices; diagnosed by upper endoscopy with good hemostasis achieved with endoscopic treatment.
- Bleeding varices; diagnosed by upper endoscopy but hemostasis could not be achieved with endoscopic treatment.
- Fundal gastric varices with Presence of contraindication for TIPS such as repeated attacks of hepatic encephalopathy due to Portosystemic shunt, Model of End Stage Liver disease score (MELD) >18.
- Fundal varices with catheterizable portosystemic shunt such as gastrorenal shunt or gastrocaval shunt.
Key exclusion criteria (4 listed)
- Complete portal vein thrombosis
- Splenic vein thrombosis
- Intractable ascites (TIPS is better)
- Uncontrolled esophageal varices (high risk for bleeding) and TIPS is better
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 |
|---|---|---|
| Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injectionAlso: EUS-guided coil embolization combined with endoscopic cyanoacrylate injectionStandard diagnostic endoscopy will be done and Fundal varices will be assessed. EUS procedures will be performed using linear endoscope under general anesthesia. Use EUS to assess the anatomy of gastric varices, observe the blood flow, scan the portal venous system, left renal vein, confirm the location of the shunt, and measure the diameter of the shunt. Puncture the gastric fundal variceal vein at the lower esophagus near the cardia and place the coil into the shunt and immediately inject with sclerosant and cyanoacrylate under the guidance of EUS using a sandwich method (cyanoacrylate, sclerosant and cyanoacrylate) via endoscope. Use color Doppler ultrasound to observe the blood flow in the variceal veins to evaluate the embolization effect. | Procedure or surgery | EUS-guided coil embolization combined with endoscopic cyanoacrylate injection |
| Ballon-occluded retrograde transvenous obliterationAlso: BRTOA balloon occlusion catheter will be inserted into the venous end of the gastro-renal or gastro-caval shunt via the right femoral vein or internal jugular vein. Balloon-occluded retrograde venogram will be done to evaluate degree of retrograde filling of the gastric varices and presence of collateral veins. Any significant large collateral veins seen will be occluded with coils using microcatheter to prevent leakage of the sclerosant into the systemic circulation. Then, sclerosant agent (ethanol-amine oleate, Sodium tetradecyl sulphate, or polidocanol) will be injected into the portosystemic shunt till complete filling of the gastric varices and part of the feeding veins. Finally, the balloon left in place for 2-12 hours then gradually will be deflated when complete occlusion of blood flow of the target shunt is achieved. | Procedure or surgery | Ballon-occluded retrograde transvenous obliteration |
Primary outcome
Gastric varices bleeding control
Time frame: 7 days
Teatment using EUS- guided coil with cyanoacrylate injection in group of patients and other group treatment using Balloon-Occluded Retrograde Transvenous Obliteration Gastric varices bleeding control within 1 week The parameter will be assesed is incidence of bleeding after the procedure number of attacks of haematemsis and melena)
Time of procedure
Time frame: 1 day
Time of the whole procedure of EUS and BRTO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 30697445Boregowda U, Umapathy C, Halim N, Desai M, Nanjappa A, Arekapudi S, Theethira T, Wong H, Roytman M, Saligram S. Update on the management of gastrointestinal varices. World J Gastrointest Pharmacol Ther. 2019 Jan 21;10(1):1-21. doi: 10.4292/wjgpt.v10.i1.1.
- Background: PubMed 35133625Baig M, Ramchandani M, Puli SR. Safety and efficacy of endoscopic ultrasound-guided combination therapy for treatment of gastric varices: a systematic review and meta-analysis. Clin J Gastroenterol. 2022 Apr;15(2):310-319. doi: 10.1007/s12328-022-01600-0. Epub 2022 Feb 8.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound-guided coil embolization combined with endoscopic cyanoacrylate injection and Ballon-occluded retrograde transvenous obliteration in people with Gastric Varix, run by Assiut University.
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 5 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 16 Aug 2022. 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 Sara Mahrous, assistant lecturer (+21009605484, sarah.3000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric varices bleeding control (time frame: 7 days). 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?
On the ClinicalTrials.gov record for NCT05500625, which also lists 2 linked publications.
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 16 Aug 2022.