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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1. Technical success- defined as completion of the intended procedure
研究概览
简要总结
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.
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
- •Age group- ≥18
- •Patients diagnosed with gastric varices type GOV2 or IGV1 according to the Sarin classification
- •Treated for active bleed or secondary prophylaxis.
排除标准
- 未提供
结局指标
主要结局
1. Technical success- defined as completion of the intended procedure
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. Clinical success- defined as complete and immediate obliteration of the varix,
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.
evaluated via esophagogastroduodenoscopy (EGD) and the absence of flow during
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.
EUS Doppler evaluation
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. Reappearance of gastric varices during follow-up(2. Rebleeding, the need for reintervention)
研究者
Dr Prachis ashdhir
SMS medical college Jaipur