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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Proportion of cases with obliteration of varices evaluated via EUS doppler
研究概览
简要总结
Gastric varices are important cause of hemetemesis in patients of portal hypertension either in cirrhotic or non cirrhotics 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 newer endoscopic ultrasound guided coil embolization with gelatin sponge and coil embolization with cyanoacryalte glue injection in management of gastrc varices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with age ≥ 18 years
- •Diagnosed with gastric varices type GOV2 or IGV1 on upper GI endoscopy according to the sarin classification.
- •All patients will be included irrespective of bleeding status (past bleeder/ non bleeder / active bleeder).
排除标准
- •Age < 18 years and > 75 year of age
- •Platelet count < 50 000 /dl or an international normalized ratio (INR) ≥ 2
- •Pregnant or nursing female
- •Patient with prior surgery of upper gastrointestinal tract
- •Hemodyanimically unstable/ Shock (bp < 90 mm Hg)
- •EUS specific procedural contraindication 8.
结局指标
主要结局
1. Proportion of cases with obliteration of varices evaluated via EUS doppler
时间窗: 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. Proportion of cases with reappearance of varices
时间窗: 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.
3. Proportion of cases with rebleeding
时间窗: 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.
4. Proportion of cases with need for reintervention
时间窗: 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.
5. Proportion of cases needs blood transfusion
时间窗: 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.
6. Proportion of cases with pre and post treatment hemoglobin values.
时间窗: 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.
7. Proportion of cases with adverse events
时间窗: 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.
8. Proportion of cases with technical success
时间窗: 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.
次要结局
- 1. Proportion of cases needs blood transfusion(2. Proportion of cases with pre and post treatment hemoglobin values.)
研究者
Dr Ashok Jhajharia
SMS MEDICAL COLLEGE AND HOSPITAL