Glue; DependenceGLUENCT05038319
SAFETY AND EFFICACY OF ENDOSCOPIC CONVENTIONAL CYANOACRYLATE GLUE VS EUS-GUIDED COIL PLUS CYANOACRYLATE TECHNIQUE IN THE TREATMENT OF GASTRIC VARICES: A RANDOMIZED CONTROLLED TRIAL
A study testing EUS in people with Glue; Dependence, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
To compare safety and efficacy of Endoscopic conventional technique (cyanoacrylate alone) to the EUS-guided injection technique (coil and cyanoacrylate) in the treatment of gastric varices. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glue; Dependence
- What is being tested?
- EUS
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2020to 1 May 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, patients diagnosed with
- gastric varices larger than 2.0 cm in total diameter of the vascular pseudotumor type GOV2 or IGV 1.
- Active bleeder
- Secondary prophylaxis - h/o previous bleed
- High risk GV (GOV 2/IGV 1) - Baveno VI-
- Primary prophylaxis
Show all 13Show fewer
- Excusion criteria:
- Previous HRS
- MOF
- Platelet <50,000/cumm
- INR>2
- Esophageal stricture
- Iodine allergy (for EV)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082
SATYA MAHARSHI, MBBS MD, 04023378888, maharshi2059@gmail.com
About this study
Official title: SAFETY AND EFFICACY OF ENDOSCOPIC CONVENTIONAL CYANOACRYLATE GLUE VS EUS-GUIDED COIL PLUS CYANOACRYLATE TECHNIQUE IN THE TREATMENT OF GASTRIC VARICES
To compare safety and efficacy of Endoscopic conventional technique (cyanoacrylate alone) to the EUS-guided injection technique (coil and cyanoacrylate) in the treatment of gastric varices.
Methods:
Read more
Patient recruitment:
Patients would be recruited from the endoscopy centre prior to their scheduled endoscopic intervention.
Study intervention :- Cyanoacrylate injection and EUS guided coil and glue injection The procedures would be performed by experienced endoscopists. The procedure would be performed under conscious sedation or monitored anaesthesia. The procedures would be performed by a therapeutic endoscope with the through the scope method. The endoscope would be used to reach the site of Varices. In Conventional technique treatment with cyanoacrylate the injection was performed using a 23-G sclerotherapy needle catheter (Interject®,Cook). One vial of N-butyl-2-cyanoacrylate (0.5 mL) was mixed with Lipiodol® in a 1:1 ratio, and injected intravesically as a 1 mL bolus. The injection was repeated until total hardening of the varix. In treatment with coil and cyanoacrylate once the gastric varix was identified, the total diameter of the vascular pseudotumor was measured and the puncture was made at the site of the widest varix. The puncture was performed using a 19 G needle (Expect®,Cook). The size of the coil used was selected based on the size of the widest varix in the pseudotumor; the size of the coil after release should not be greater than the caliber of the vessel. Following coil deployment, 2 mL of distilled water was injected, followed by one vial (0.5 mL) of N-butyl-2-cyanoacrylate mixed with Lipiodol in 1:1 ratio. Then, another 2 mL of distilled water was injected, and the needle was removed.
COIL and GLUE:
Cyanoacrylate injection remains the conventional treatment method. Since coils were first used to treat ectopic varices by Levy in 2008(6), this technique has been increasingly implemented into clinical practice. However, its higher cost has been a limiting factor in more widespread use.
Depending on the ectasia of the varix the following coil was deployed: 8 mm x 20 cm, 10 mm x 20 cm, or 10 mm x 30 cm (Interlock-18 Fibered IDC Occlusion System,Cook).
D.2.5 Randomization Patients were randomized into two groups: group I received standard endoscopic treatment with injection of a cyanoacrylate/Lipiodol (1:1) solution and group II received EUS-guided coiling and cyanoacrylate injection treatment A computer-based randomization list was generated with the online software Research Randomizer with 1:1 ratio (www.randomizer.org). An independent researcher not involved in this trial created the randomization list and sealed sequential opaque envelopes containing the random allocation sequence. The complete list generation occurred before the first enrollment.
D.2.6 Post-procedural management After the procedure, EUS with Doppler flow evaluation was repeated to check the presence or absence of flow within the varix. The patients remained under observation in the GI endoscopy unit for at least one hour, being released if no complaint was reported. After endoscopic treatment, all patients underwent thoracic and abdomen computerized tomography (CT) scanning within one week, independent of the development of clinical symptoms.
Read the detailed description
All patients returned to the GI endoscopy unit approximately one month after initial endoscopic intervention for a repeat EUS evaluation.
Technical success is defined as complete obliteration of varices and absence of flow signal.On this occasion, if any residual flow was identified, new treatment was performed following the same technique initially used, and another evaluation was thus performed one month later. This scenario was repeated until complete thrombosis was achieved.
Complications that occurred during the procedure or within seven days post-intervention were defined as early complications, whereas those that occurred greater than or equal to seven days post-intervention were defined as late complications.
Recurrence was defined as evidence of any flow within the varix which occurred after initial obliteration had been confirmed.
5.Esophageal stricture 6.Iodine allergy (for EV)
Follow-up:
Once complete thrombosis was achieved, follow-up evaluations were performed three and nine months later (i.e. four and 10 months after therapy), at which time patients were questioned about any post-procedure complications, and underwent another EUS examination, which permitted repeat evaluations of flow within the treated vessel.
- Conditions
- Glue; Dependence
- Being tested
- EUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUSProcedure or surgery
The procedures would be performed by a therapeutic endoscope with the through the scope method. The endoscope would be used to reach the site of Varices.
| Study group | Role | What they receive |
|---|---|---|
| Cyanoacrylate injection and EUS guided coil and glue injection | Active comparator | The procedure would be performed under conscious sedation.The endoscope would be used to reach the site of Varices. In Conventional technique treatment with cyanoacrylate the injection was performed using a 23-G sclerotherapy needle catheter . One vial of N-butyl-2-cyanoacrylate (0.5 mL) was mixed with Lipiodol) in a 1:1 ratio, and injected intravesically as a 1 mL bolus. The injection was repeated until total hardening of the varix. In treatment with coil and cyanoacrylate once the gastric varix was identified, the total diameter of the vascular pseudotumor was measured and the puncture was made at the site of the widest varix. The puncture was performed using a 19 G needle . the size of the coil after release should not be greater than the caliber of the vessel. Following coil deployment, 2 mL of distilled water was injected, followed by one vial (0.5 mL) of N-butyl-2-cyanoacrylate mixed with Lipiodol in 1:1 ratio. Receives: Procedure: EUS |
| COIL and GLUE | Placebo comparator | Cyanoacrylate injection, first published by Soehendra in 1986, remains the conventional treatment method.
Since coils were first used to treat ectopic varices by Levy in 2008(6), this technique has been increasingly implemented into clinical practice. However, its higher cost has been a limiting factor in more widespread use.
Depending on the ectasia of the varix the following coil was deployed: 8 mm x 20 cm, 10 mm x 20 cm, or 10 mm x 30 cm (Interlock-18 Fibered IDC Occlusion System,Cook). Receives: Procedure: EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome was to compare the occurrence of embolism in the two groups
Technical success is defined as complete obliteration of varices and absence of flow signal.On this occasion, if any residual flow was identified, new treatment was performed following the same technique initially used, and another evaluation was thus performed one month later. This scenario was repeated until complete thrombosis was achieved.
Measured: 4 months
Secondary outcomes (1)
Secondary outcome was to evaluate the efficacy of the two techniques in the eradication of the varices.
Technical success is defined as complete obliteration of varices and absence of flow signal.On this occasion, if any residual flow was identified, new treatment was performed following the same technique initially used, and another evaluation was thus performed one month later. This scenario was repeated until complete thrombosis was achieved.
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Jan 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glue; DependenceStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- RAJESH GUPTA, MBBS MD, Study director, ASIAN INSTITUTE OF GASTROENTEROLOGY PVT LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038319
- Sponsor's protocol ID
- EUS GLUE 001
- Acronym
- GLUE
- Status last verified
- Sep 2021
- First submitted
- 12 Aug 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFETY AND EFFICACY OF ENDOSCOPIC CONVENTIONAL CYANOACRYLATE GLUE VS EUS-GUIDED COIL PLUS CYANOACRYLATE TECHNIQUE IN THE TREATMENT OF GASTRIC VARICES
- ClinicalTrials.gov ID
- NCT05038319
- Acronym / sponsor ID
- GLUE / EUS GLUE 001
- Conditions
- Glue; Dependence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 9 Sep 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.
To compare safety and efficacy of Endoscopic conventional technique (cyanoacrylate alone) to the EUS-guided injection technique (coil and cyanoacrylate) in the treatment of gastric varices.
Methods:
Patient recruitment:
Patients would be recruited from the endoscopy centre prior to their scheduled endoscopic intervention.
Study intervention :- Cyanoacrylate injection and EUS guided coil and glue injection The procedures would be performed by experienced endoscopists. The procedure would be performed under conscious sedation or monitored anaesthesia. The procedures would be performed by a therapeutic endoscope with the through the scope method. The endoscope would be used to reach the site of Varices. In Conventional technique treatment with cyanoacrylate the injection was performed using a 23-G sclerotherapy needle catheter (Interject®,Cook). One vial of N-butyl-2-cyanoacrylate (0.5 mL) was mixed with Lipiodol® in a 1:1 ratio, and injected intravesically as a 1 mL bolus. The injection was repeated until total hardening of the varix. In treatment with coil and cyanoacrylate once the gastric varix was identified, the total diameter of the vascular pseudotumor was measured and the puncture was made at the site of the widest varix. The puncture was performed using a 19 G needle (Expect®,Cook). The size of the coil used was selected based on the size of the widest varix in the pseudotumor; the size of the coil after release should not be greater than the caliber of the vessel. Following coil deployment, 2 mL of distilled water was injected, followed by one vial (0.5 mL) of N-butyl-2-cyanoacrylate mixed with Lipiodol in 1:1 ratio. Then, another 2 mL of distilled water was injected, and the needle was removed.
COIL and GLUE:
Cyanoacrylate injection remains the conventional treatment method. Since coils were first used to treat ectopic varices by Levy in 2008(6), this technique has been increasingly implemented into clinical practice. However, its higher cost has been a limiting factor in more widespread use.
Depending on the ectasia of the varix the following coil was deployed: 8 mm x 20 cm, 10 mm x 20 cm, or 10 mm x 30 cm (Interlock-18 Fibered IDC Occlusion System,Cook).
D.2.5 Randomization Patients were randomized into two groups: group I received standard endoscopic treatment with injection of a cyanoacrylate/Lipiodol (1:1) solution and group II received EUS-guided coiling and cyanoacrylate injection treatment A computer-based randomization list was generated with the online software Research Randomizer with 1:1 ratio (www.randomizer.org). An independent researcher not involved in this trial created the randomization list and sealed sequential opaque envelopes containing the random allocation sequence. The complete list generation occurred before the first enrollment.
D.2.6 Post-procedural management After the procedure, EUS with Doppler flow evaluation was repeated to check the presence or absence of flow within the varix. The patients remained under observation in the GI endoscopy unit for at least one hour, being released if no complaint was reported. After endoscopic treatment, all patients underwent thoracic and abdomen computerized tomography (CT) scanning within one week, independent of the development of clinical symptoms.
Detailed description
All patients returned to the GI endoscopy unit approximately one month after initial endoscopic intervention for a repeat EUS evaluation.
Technical success is defined as complete obliteration of varices and absence of flow signal.On this occasion, if any residual flow was identified, new treatment was performed following the same technique initially used, and another evaluation was thus performed one month later. This scenario was repeated until complete thrombosis was achieved.
Complications that occurred during the procedure or within seven days post-intervention were defined as early complications, whereas those that occurred greater than or equal to seven days post-intervention were defined as late complications.
Recurrence was defined as evidence of any flow within the varix which occurred after initial obliteration had been confirmed.
5.Esophageal stricture 6.Iodine allergy (for EV)
Follow-up:
Once complete thrombosis was achieved, follow-up evaluations were performed three and nine months later (i.e. four and 10 months after therapy), at which time patients were questioned about any post-procedure complications, and underwent another EUS examination, which permitted repeat evaluations of flow within the treated vessel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyanoacrylate injection and EUS guided coil and glue injection | Active comparator | Procedure: EUSThe procedure would be performed under conscious sedation.The endoscope would be used to reach the site of Varices. In Conventional technique treatment with cyanoacrylate the injection was performed using a 23-G sclerotherapy needle catheter . One vial of N-butyl-2-cyanoacrylate (0.5 mL) was mixed with Lipiodol) in a 1:1 ratio, and injected intravesically as a 1 mL bolus. The injection was repeated until total hardening of the varix. In treatment with coil and cyanoacrylate once the gastric varix was identified, the total diameter of the vascular pseudotumor was measured and the puncture was made at the site of the widest varix. The puncture was performed using a 19 G needle . the size of the coil after release should not be greater than the caliber of the vessel. Following coil deployment, 2 mL of distilled water was injected, followed by one vial (0.5 mL) of N-butyl-2-cyanoacrylate mixed with Lipiodol in 1:1 ratio. |
| COIL and GLUE | Placebo comparator | Procedure: EUSCyanoacrylate injection, first published by Soehendra in 1986, remains the conventional treatment method. Since coils were first used to treat ectopic varices by Levy in 2008(6), this technique has been increasingly implemented into clinical practice. However, its higher cost has been a limiting factor in more widespread use. Depending on the ectasia of the varix the following coil was deployed: 8 mm x 20 cm, 10 mm x 20 cm, or 10 mm x 30 cm (Interlock-18 Fibered IDC Occlusion System,Cook). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years old, patients diagnosed with
- gastric varices larger than 2.0 cm in total diameter of the vascular pseudotumor type GOV2 or IGV 1.
- Active bleeder
- Secondary prophylaxis - h/o previous bleed
- High risk GV (GOV 2/IGV 1) - Baveno VI-
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EUSThe procedures would be performed by a therapeutic endoscope with the through the scope method. The endoscope would be used to reach the site of Varices. | Procedure or surgery | COIL and GLUE, Cyanoacrylate injection and EUS guided coil and glue injection |
Primary outcome
Primary outcome was to compare the occurrence of embolism in the two groups
Time frame: 4 months
Technical success is defined as complete obliteration of varices and absence of flow signal.On this occasion, if any residual flow was identified, new treatment was performed following the same technique initially used, and another evaluation was thus performed one month later. This scenario was repeated until complete thrombosis was achieved.
1 secondary outcome
Secondary outcome was to evaluate the efficacy of the two techniques in the eradication of the varices.
Time frame: 9 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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.
RAJESH GUPTA, MBBS MD study director
ASIAN INSTITUTE OF GASTROENTEROLOGY PVT LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS in people with Glue; Dependence, run by Asian Institute of Gastroenterology, 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 13 inclusion and 0 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 9 Sep 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. Some participants in this study may receive a placebo. 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 Satya Maharshi Tummalapalli, MBBS MD (04023378888, maharshi2059@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome was to compare the occurrence of embolism in the two groups (time frame: 4 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 9 Sep 2021.