A Randomized, Double-blind, Comparative, Effectiveness and Safety Study of Eleview vs. Hetastarch in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 11mm
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Sydney Resection Quotient (SRQ)
研究概览
简要总结
EMR is a technique used for the removal of flat or sessile neoplasms confined to the superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas, other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been found to minimize mechanical or electrocautery damage to the deep layers of the gastrointestinal tract wall as the injectate provides a "safety cushion" as such between the area to be removed and healthy mucosal tissue.
Several solutions are used today for injecting lesions including saline, hyaluronic acid, and hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes, which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but is expensive and is not readily available in the U.S.
A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic procedures and recently approved by the FDA. This injectate boasts a cushion of excellent height and duration through the use of an oil-in-water emulsion. However, the initial cost of this material is quite high ($80 per 10 ml).
Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably inexpensive solution that provides prolonged submucosal elevation and lowers procedure times. Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal submucosal injectate.
This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will not be included.
详细描述
Injectate randomization:
Study patients will be randomly assigned to the Eleview or the Hetastarch treatment group in a 1:1 ratio. Randomization will occur at the site using envelopes provided by the Investigator. The envelope's contents will specify the treatment assignment for each patient and opened by the research team (PI will be blinded). The investigators will monitor the safety and effectiveness data. The appropriate solutions will be injected into the submucosal space beneath the lesion(s) to be excised before the lesion(s) is/are removed. Subjects in both groups will receive the appropriate volume of injectate deemed necessary by the PI for the individual patient.
Sample size and Statistical Analysis At least 200 patients will be enrolled. 100 of these patients will be randomized to Eleview injectate and 100 will be given the standard of care, Hetastarch injectate only. Efficacy and safety of Eleview injectate has only been reviewed in one previous study. Therefore, the planned sample size was not calculated using a statistical power analysis, but was regarded as sufficient to repeat the objectives of the COSMO study (2017) and satisfy the exploratory purposes of the present study.
Study personnel will carry out a simple randomization using a commonly used online generator. Randomization assignments will then be sealed until day of procedure until patient eligibility has been confirmed. The Principal Investigator will remain blinded and will perform all data analysis after completion of the study.
Data will be summarized and compared using classic descriptive statistics, i.e. mean, standard deviation, coefficient of variation (%), minimum, median and maximum values for quantitative variables, and frequencies for qualitative variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The Investigator is blinded to the randomization process but can be unblinded after the product has been dispensed if the patient has a medical issue that requires it.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sex and age: men and women > 18 years old
- •Subjects referred for EMR of polyps of size ≥11 mm
- •ASA score 1, 2 or
- •Contraception: Women of childbearing potential must have a negative pregnancy test (one is provided as the standard of care) or sign a waiver. Post-menopausal women must have been in that status for at least 1 year (per standard of care).
- •Subject is willing and able to participate in the study procedures and to understand and sign the informed consent
排除标准
- •Age: Subjects is under 18 years old
- •Consent: Vulnerable subjects including those who are unable to consent
- •Pregnancy: Pregnant or breastfeeding women
- •ASA score <3
- •Physical findings: Abnormal physical findings that may interfere with the study objectives
- •Study participation: Subjects currently participating in another clinical study or previously enrolled in another clinical study in the last 30 days
- •Excluded lesions:
- •Lesions less than 11 mm in largest dimension
- •Lesions involving the muscularis propria (T2 lesions)
- •Ulcerated depressed lesions (Paris type III) or pathology proven invasive carcinoma
- •Proven malignant disease locally advanced or with metastasis
- •Active inflammatory bowel disease lesion, e.g ulcerative colitis, Crohn's disease
- •Endoscopic appearance of invasive malignancy
- •Previous partial resection or attempted resection of the lesion
- •Allergy: Proven or potential allergic reaction to study products or history of anaphylaxis to drugs
- •Severe liver disease.
- •Known or suspected gastrointestinal obstruction or perforation, active diverticulitis, toxic megacolon,
- •Inflammatory bowel disease e.g ulcerative colitis or Crohn's disease
- •Hemostasis disorders (eg Von Willebrand disease, factor V Leiden thrombophilia or haemophilia), known clotting disorder (INR>1.5).
- •Subject with any other current serious medical conditions that would increase the risks associated with taking part in the study.
- •Patients must be advised to stop anticoagulation medications prior to the procedure per local practice guidelines and should re-start as clinically indicated after the procedure.
研究组 & 干预措施
Eleview
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
干预措施: Eleview (Drug)
Hetastarch
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
干预措施: Hetastarch (Drug)
结局指标
主要结局
Sydney Resection Quotient (SRQ)
时间窗: During the large polyp removal
Comparison of the Sydney Resection Quotient between EMRs done using Eleview vs EMRs done using Hetastartch as the injection fluid. The Sydney Resection Quotient (SRQ) is the size of the polyp divided by the number of pieces in which the polyp was resected. A larger SRQ is better than a smaller SRQ.
次要结局
- Number of Re-injections Needed During Resection(During the large polyp removal)
- Mound Concentration Diameter(During the large polyp removal)
- Injected Volume Needed for Complete Removal of Lesion(During the large polyp removal)
- Injected Volume Needed for Initial Lesion Lift(During initial injection portion of large polyp removal)
- Ease of Injection(During the large polyp removal)
- Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation.(During the large polyp removal)
- Number of En Bloc Resections(During the large polyp removal)
- Number of Pieces Resected Using Snares(During the large polyp removal)
- Mound Concentration Height(During the large polyp removal)
- Mound Duration(During the large polyp removal)
- Safety Outcomes as Assessed by Complications During or After the Procedure(during large polyp removal through 30 days post procedure)
- Time Required to Remove the Lesion(During the large polyp removal)
研究者
Douglas K. Rex
Endoscopy Chief
Indiana University