Endoscopic Ultrasound (EUS) guided management of gastric varices: coil embolisation with absorbable gelatin sponge versus coil embolisation with cyanoacrylate glue injection

Efficacy and safety of endoscopic ultrasound guided coil embolisation with absorbable gelatin sponge versus coil embolisation with cyanoacrylate glue injection for management of gastric varices: A randomized comparative study - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060491

Enrollment

Registered

2023-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K318- Other specified diseases of stomach and duodenum

Interventions

Intervention1: Coil plus sponge gelform: Patients will be randomly allocated in a 1:1 manner to either EUS-guided coil embolization with absorbable gelatin sponge OR EUS guided coil embolization with

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient with age = 18 years 2. Diagnosed with gastric varices type GOV2 or IGV1 on upper GI endoscopy according to the sarin classification. 3. All patients will be included irrespective of bleeding status (past bleeder/ non bleeder / active bleeder).

Exclusion criteria

Exclusion criteria: 1. Age 75 year of age 2. Platelet count 3. Patient with concurrent hepatorenal syndrome and/or multiorgan failure 4. Pregnant or nursing female 5. Patient with prior surgery of upper gastrointestinal tract 6. Hemodyanimically unstable/ Shock (bp 7. EUS specific procedural contraindication 8. Patients who did not give consent

Design outcomes

Primary

Measure	Time frame
1.Proportion of cases with obliteration of varices evaluated via EUS doppler 2.Proportion of cases with reappearance of varices 3.Proportion of cases with rebleeding 4.Proportion of cases with need for reintervention 5.Proportion of cases needs blood transfusion 6.Proportion of cases with pre and post treatment hemoglobin values. 7.Proportion of cases with adverse events 8.Proportion of cases with technical success Timepoint: Follow-up EGD and an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month and 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival and adverse events will be evaluated. Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital and review of medical, EGD, and EUS records.	—

Measure

Time frame

1.Proportion of cases with obliteration of varices evaluated via EUS doppler 2.Proportion of cases with reappearance of varices 3.Proportion of cases with rebleeding 4.Proportion of cases with need for reintervention 5.Proportion of cases needs blood transfusion 6.Proportion of cases with pre and post treatment hemoglobin values. 7.Proportion of cases with adverse events 8.Proportion of cases with technical success Timepoint: Follow-up EGD and an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month and 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival and adverse events will be evaluated. Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital and review of medical, EGD, and EUS records.

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Secondary

Measure	Time frame
1. Proportion of cases needs blood transfusion 2. Proportion of cases with pre and post treatment hemoglobin values. 3. Proportion of cases with adverse events 4. Proportion of cases with technical success Timepoint: Follow-up EGD and an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month and 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival and adverse events will be evaluated. Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital and review of medical, EGD, and EUS records.	—

Measure

Time frame

1. Proportion of cases needs blood transfusion 2. Proportion of cases with pre and post treatment hemoglobin values. 3. Proportion of cases with adverse events 4. Proportion of cases with technical success Timepoint: Follow-up EGD and an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month and 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival and adverse events will be evaluated. Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital and review of medical, EGD, and EUS records.

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Countries

India

Contacts

Public ContactDr Namit Gupta

SMS MEDICAL COLLEGE AND HOSPITAL

drashokjhajharia@gmail.com9414236572

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026