Comparison Between Epinephrine Versus Tranexamic Acid Usage During Upper Gastrointestinal Tract Endoscopic Resection Procedures for the Reduction of Intraprocedural and Postprocedural Bleeding
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postprocedural bleeding
研究概览
简要总结
Endoscopic resection of gastrointestinal lesions may prevent cancer. However, resection is associated with adverse events such as bleeding. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects and may prevent bleeding. The investigators aim to evaluate the effect of local TXA on preventing intraprocedural and postprocedural bleeding in patients undergoing endoscopic mucosal resection (EMR) of upper gastrointestinal lesions.
详细描述
Endoscopic resection (ER) is an endoscopic technique used for the removal of sessile or flat neoplasms confined to the superficial layers (mucosa and submucosa) of the gastrointestinal (GI) tract.
This technique is not without risk, and clinically significant intraprocedural bleeding and post-ER bleeding remain the most frequently encountered serious adverse event.
The bleeding rate associated with ER varies for the different regions of the GI tract. This is most probably due to differences in the vascularity within the wall of the GI tract in each region.
Intraprocedural bleeding in the stomach and duodenum is more frequent and may be as high as 11.5% and 19.3%, respectively. Delayed bleeding has been reported at about 5% for these sites.
Management of bleeding is often resource intensive and may necessitate hospitalization, blood transfusion, and repeat intervention. Some techniques, such as soft coagulation with the tip of a snare; epinephrine injection; hemoclip placement or proton-pump inhibitor treatment, are used to decrease the risk of bleeding or treat active bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for endoscopic resection of a non-neoplastic and neoplastic lesions in the upper GI presenting to our tertiary academic center.
- •Age > 18 years
排除标准
- •patients with histories of allergic reactions to TXA
- •history of seizures
- •pregnancy
研究组 & 干预措施
Tranexamic acid
During the ER procedure, de-identified injectate solution will be introduced. Study group: 9 ml of standart solution for injection [Consisit of: 6 ml indigo carmine + 500 ml succinylated gelatin 4% (Gelofusine; B. Braun, Crissier, Switzerland)] + 1 ml (100mg) of TXA (tranexamic acid).
干预措施: Tranexamic acid (Drug)
Epinephrine
During the ER procedure, de-identified injectate solution will be introduced. 9 ml of standart solution for injection [Consisit of: 6 ml indigo carmine + 500 ml succinylated gelatin 4% (Gelofusine; B. Braun, Crissier, Switzerland)] + 1 ml epinephrine 1:100,000 + 1 ml saline 0.9%.
干预措施: Epinephrine injection (Drug)
结局指标
主要结局
Postprocedural bleeding
时间窗: 2 weeks post-procedure
To compare the severity of postprocedural bleeding between those receiving TXA and those receiving epinephrine.
Intraprocedural bleeding
时间窗: During procedure
To compare the severity of intraprocedural bleeding between those receiving TXA and those receiving epinephrine.
次要结局
- Side effects(2 weeks post-procedure)