Gut Guarding Gel for Endoscopic Resection to Treat Early Gastroenterological Tumor and Polyps (Evaluation of the Safety of Sodium Alginate Mixed With Calcium Lactate on Endoscopic Mucosal Resection / Endoscopic Submucosal Dissection)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of Patients With Postpolypectomy Electrocoagulation Syndrome
研究概览
简要总结
The aim of the investigators' study is to evaluate the mucosa-elevating capacity and clinical safety of Sodium Alginate (SA) mixed with Calcium Lactate in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection.
详细描述
The study will evaluate the mucosa-elevating capacity and clinical safety of Gut Guarding Gel (the Sodium Alginate (SA) mixed with Calcium Lactate) in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection to treat early gastroenterological tumor and polyps.
All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.
The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Determine the rates of the delayed bleeding/perforation, postpolypectomy electrocoagulation syndrome, and the late tissue injury.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria in order to be entered into the study:
- •A. Both genders of patients age 20 or older.
- •B. Superficial tumors or polyps found either in esophagus, stomach, or large intestine via endoscopic diagnosis.
- •C. Tumor or polyps ≧ 20 millimeters.
- •D. Superficial tumor or polyps found either in esophagus, stomach, or large intestine have never received any kind of endoscopic treatment.
- •E. No evidence of depth of submucosal invasion or metastasis via endoscopy.
排除标准
- •If patients meet any of the following criteria they may not be entered into the study:
- •A. Patients suffering from other advanced malignant tumors.
- •B. White Blood Cell< 2000 μL or Severe thrombocytopenia（Platelet count < 50,000 μL)，or blood coagulation abnormalities uncorrectable .
- •C. Patients taking anti- thrombocytopenia or anti-coagulation medicine, and medication cannot be stopped under physicians' consideration.
- •D. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.
- •E. Evidence of depth of submucosal invasion or metastasis via endoscopy.
- •F. Unable to follow-up by endoscopy.
- •G. Unwilling to sign informed consent.
- •H. Allergic to pharmaceutical excipients related to this medical device (Calcium Lactate or Sodium Alginate).
结局指标
主要结局
Number of Patients With Postpolypectomy Electrocoagulation Syndrome
时间窗: 5 days after resection
To evaluate patient's clinical symptoms and patient's complaints about the post-polypectomy electrocoagulation syndrome. The post-polypectomy electrocoagulation syndrome occurs after performing the endoscopy, and its signs and symptoms are similar to the signs and symptoms of perforation, such as severe abdominal pain and fever.
次要结局
- Number of Patients With Delayed Bleeding/Perforation(An average of 4 weeks)
- Number of Patients With Late Tissue Injury(One month after endoscopy)