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临床试验/NCT03277937
NCT03277937已完成不适用

The Use of Angiography for Determination and Confirmation of the Feeder Vessel as a Modification of the Original EUS-guided Coils and Cyanoacrylate Therapy for Gastric Varices

Instituto Ecuatoriano de Enfermedades Digestivas2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
efficacy of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate, confirm and target the feeder vessel in GV treatment.

研究概览

简要总结

INTRODUCTION: Bleeding from gastric varices (GV) is associated with a high mortality rate. Injection of cyanoacrylate (CYA) using standard gastroscope has demonstrated to achieve higher hemostasis and lower rebleeding rates compared to band ligation or sclerotherapy. Nevertheless CYA treatment is known to be associated with significant adverse events. Pulmonary embolism due to CYA injection is a serious and sometimes fatal complication of this therapy. These patients usually have respiratory symptom, however this complication can be present in asymptomatic patients, being demonstrated only by a pathological CT scan. On the other hand, it has been described that the risk of glue embolism dependent on the volume of CYA injected, being significantly greater with high volumes. Other complications related to CYA injection are hemorrhage from injection site ulcers, fever, peritonitis, needle impaction, and even death. Also the injection material can cause serious damage to the endoscope.

Currently, endoscopic injection of CYA can be performed by direct visualization using a standard gastroscope or guided by Endoscopic Ultrasound (EUS) with injection of CYA alone or in combination with coils. The injection of coils in conjunction with CYA may reduce or eliminate the risk of glue embolization as coils can function as a scaffold to retain CYA within the varix and may decrease the amount of glue injection needed to achieve obliteration. It has been previously demonstrated that treatment under EUS guidance may have some benefits. It allows a precise targeting of the varix lumen or afferent feeding veins, being the vessel obstructed with less amount of CYA than used for the "blind" injection by standard endoscopy, reducing the risk of glue embolism. EUS can confirm varix obliteration by Doppler effect and also the visualization of GV is not impaired by blood or food in the stomach, thus it can be used in the setting of active hemorrhage.

详细描述

On the other hand, despite the EUS-injection of coils and CYA have shown very promising results, it is extremely important to have experience performing this technique, as the injection in a wrong vessel could be catastrophic. It has been develop in our unit a modification of Binmoeller´s original technique by performing the injection of coils and CYA by EUS and fluoroscopic guidance. The performance of an angiography guided by EUS and under fluoroscopy evaluation, represents a modification to the original technique that add some benefits: 1) The injection of water-soluble contrast allows identifying the variceal flow and the afferent feeding vessel (left gastric vein) and avoiding splenic vessels embolization. 2) Also, if there is a shunt it can be detected and the injection of CYA can be avoided. 3) In case of active bleeding the angiography allows visualizing which varix is bleeding, and target the correct vessel.

The aim of this study is to show the results and potential benefits by adding an angiography to the original EUS-guided injection of coils in combination with CYA technique, to determinate and confirm the feeder vessel in GV treatment.

MATERIALS AND METHODS

Study design: It will be an interventional, descriptive and prospective study, performed in the Ecuadorian Institute of Digestive Disease (IECED), Omni Hospital Academic Tertiary Center Ecuador. Patients have been included from July 2015 and will continue to be included up to October 2017. The study protocol and consent form has been approved by the institutional review board, and will be conducted according to the declaration of Helsinki. Written informed consent will be obtained from all subjects.

Population selection, inclusion and exclusion criteria: Patients above 18 years old with gastric varices (GV) on the initial standard diagnostic upper endoscopy will be enrolled. GV will be classified according to Sarin and Kumar classification. Only gastro-esophageal varices type II (GOV II) (fundal varices communicating with esophageal varices) and isolated gastric varices type I (IGV I) (fundal varices within a few centimeters of the gastric cardia) will be included. Gastro-esophageal varices type I (GOV I) will be excluded as they can be successfully treated by endoscopic band ligation. Patients with active bleeding and history of previous bleeding due to GV (secondary prophylaxis) will be included as well as patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus. The exclusion criteria will be pregnancy, concurrent hepatorenal syndrome and/or multi-organ failure, platelet count less than 50,000/ml or International Normalized Rate (INR) >2, esophageal stricture, splenic or portal vein thrombosis and allergy to iodine.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients above 18 years old with gastric varices (GV) on the initial standard diagnostic upper endoscopy will be enrolled. GV will be classified
  • Only gastro-esophageal varices type II (GOV II) (fundal varices communicating with esophageal varices) and isolated gastric varices type I (IGV I) (fundal varices within a few centimeters of the gastric cardia) will be included (according to Sarin and Kumar classification).
  • Patients with active bleeding and history of previous bleeding due to GV (secondary prophylaxis)
  • Patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus.

排除标准

  • Gastro-esophageal varices type I (GOV I) will be excluded as they can be successfully treated by endoscopic band ligation.
  • Pregnancy,
  • Hepatorenal syndrome
  • Multi-organ failure,
  • platelet count less than 50,000/ml
  • International Normalized Rate (INR) >2,
  • esophageal stricture,
  • Splenic vein thrombosis
  • Portal vein thrombosis
  • Allergy to iodine.

研究组 & 干预措施

Patients with gastric varices

Experimental

Patients above 18 years old with gastric varices (GV) on the initial standard diagnostic upper endoscopy will be enrolled and treated using angiography in EUS-injection of coils + CYA. GV will be classified according to Sarin and Kumar classification. Only gastro-esophageal varices type II (GOV II) (fundal varices communicating with esophageal varices) and isolated gastric varices type I (IGV I) (fundal varices within a few centimeters of the gastric cardia) will be included. Gastro-esophageal varices type I (GOV I) will be excluded. Patients with active bleeding and history of previous bleeding due to GV (secondary prophylaxis) will be included as well as patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus. T

干预措施: angiography in EUS-injection of coils + CYA (Procedure)

结局指标

主要结局

efficacy of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate, confirm and target the feeder vessel in GV treatment.

时间窗: 12 months

efficacy will be considered be the complete occlusion and/or disappearance of the GV and will be determinate by follow-up controls using EUS and upper endoscopy. Treatment failure and early rebleeding will be considered when bleeding occurred the first five days.

次要结局

  • safety of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate and confirm the feeder vessel in GV treatment(12 months)

研究者

发起方
Instituto Ecuatoriano de Enfermedades Digestivas
申办方类型
Other
责任方
Sponsor

研究点 (2)

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