Endoscopic ultra sonography guided thrombin with glue injection in gastric varices

To compare the efficacy and safety of EUS guided combined application of thrombin and cyanoacrylate injection with EUS guided cyanoacrylate injection alone for the management of patients with gastroesophageal varices: A randomized control trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061478

Enrollment

Registered

2024-01-15

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: Thrombin plus cyanoacrylate glue: Patients will be randomly allocated in a 1:1 manner to either EUS-guided thrombin with cyanoacrylate injection OR EUS guided cyanoacrylate injection al

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group- =18 2. Patients diagnosed with gastric varices type GOV2 or IGV1 according to the Sarin classification 3. Treated for active bleed or secondary prophylaxis

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
1. Technical success- defined as completion of the intended procedure 2. Clinical success- defined as complete and immediate obliteration of the varix, evaluated via esophagogastroduodenoscopy (EGD) and the absence of flow during EUS Doppler evaluationTimepoint: 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. Technical success- defined as completion of the intended procedure 2. Clinical success- defined as complete and immediate obliteration of the varix, evaluated via esophagogastroduodenoscopy (EGD) and the absence of flow during EUS Doppler evaluationTimepoint: 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. Reappearance of gastric varices during follow-up 2. Rebleeding, the need for reintervention 3. The complication & survival ratesTimepoint: Follow-up EGD & an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month & 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival & 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 & review of medical, EGD, & EUS records.	—

Measure

Time frame

1. Reappearance of gastric varices during follow-up 2. Rebleeding, the need for reintervention 3. The complication & survival ratesTimepoint: Follow-up EGD & an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month & 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival & 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 & review of medical, EGD, & EUS records.

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Countries

India

Contacts

Public ContactNarendra Kumar Bishnoi

SMS medical college Jaipur

pa894@yahoo.co.in9829966420

Outcome results

None listed

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