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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- 1. Technical success- defined as completion of the intended procedure
Study Overview
Brief Summary
Acute gastric variceal haemorrhage is a catastrophic complication of portal hypertension and prevalence of gastric varices in patients with portal hypertension is reported to be about 25%. It commonly presents with hematemesis and/or melena.
Bleeding from gastric varices is more severe and life-threatening than bleeding from oesophageal varices and is associated with high mortality, morbidity rates and medical care cost and it needs urgent effective
and safe treatment modalities to prevent morbidity and mortality
The purpose of this study is to statistically compare the efficacy and safety of EUS-guided combined applications of thrombin and cyanoacrylate injection with EUS-guided cyanoacrylate injection alone for the management
of patients with gastroesophageal varices type II (GOV II) and isolated gastric varices type I (IGV I) in a prospective randomized controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age group- ≥18
- •Patients diagnosed with gastric varices type GOV2 or IGV1 according to the Sarin classification
- •Treated for active bleed or secondary prophylaxis.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
1. Technical success- defined as completion of the intended procedure
Time Frame: 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.
2. Clinical success- defined as complete and immediate obliteration of the varix,
Time Frame: 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.
evaluated via esophagogastroduodenoscopy (EGD) and the absence of flow during
Time Frame: 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.
EUS Doppler evaluation
Time Frame: 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.
Secondary Outcomes
- 1. Reappearance of gastric varices during follow-up(2. Rebleeding, the need for reintervention)
Investigators
Dr Prachis ashdhir
SMS medical college Jaipur