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)

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Glue; Dependence
• Intervention / Treatment: Procedure: EUS

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Satya Maharshi Tummalapalli, MBBS MD; Phone Number: 04023378888; Email: maharshi2059@gmail.com
• Study Contact Backup: Name: RAJESH GOUD, M.PHARMA, MBA; Phone Number: 04023378888; Email: rajeshgoud761@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian Institute of Gastroenterology
      • Contact: SATYA MAHARSHI, MBBS MD; Phone Number: 04023378888; Email: maharshi2059@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cyanoacrylate injection and EUS guided coil and glue injection; 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.	Procedure: EUS; 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.
Placebo Comparator: COIL and GLUE; 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).	Procedure: EUS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 MONTHS

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Study Director: RAJESH GUPTA, MBBS MD, Asian Institute of Gastroenterology Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: September 5, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices
• Other Study ID Numbers: EUS GLUE 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No