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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 (GLUE)

Primary Purpose

Glue; Dependence

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
EUS
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glue; Dependence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Excusion criteria:

  • Previous HRS
  • MOF
  • Platelet <50,000/cumm
  • INR>2
  • Esophageal stricture
  • Iodine allergy (for EV)

Sites / Locations

  • Asian Institute of GastroenterologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cyanoacrylate injection and EUS guided coil and glue injection

COIL and GLUE

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 12, 2021
Last Updated
September 5, 2021
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT05038319
Brief Title
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
Acronym
GLUE
Official Title
SAFETY AND EFFICACY OF ENDOSCOPIC CONVENTIONAL CYANOACRYLATE GLUE VS EUS-GUIDED COIL PLUS CYANOACRYLATE TECHNIQUE IN THE TREATMENT OF GASTRIC VARICES
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glue; Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyanoacrylate injection and EUS guided coil and glue injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
COIL and GLUE
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
EUS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary outcome was to compare the occurrence of embolism in the two groups
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Secondary outcome was to evaluate the efficacy of the two techniques in the eradication of the varices.
Description
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.
Time Frame
9 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Excusion criteria: Previous HRS MOF Platelet <50,000/cumm INR>2 Esophageal stricture Iodine allergy (for EV)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satya Maharshi Tummalapalli, MBBS MD
Phone
04023378888
Email
maharshi2059@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
RAJESH GOUD, M.PHARMA, MBA
Phone
04023378888
Email
rajeshgoud761@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RAJESH GUPTA, MBBS MD
Organizational Affiliation
ASIAN INSTITUTE OF GASTROENTEROLOGY PVT LTD
Official's Role
Study Director
Facility Information:
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500082
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SATYA MAHARSHI, MBBS MD
Phone
04023378888
Email
maharshi2059@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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