"Cap-assisted" Endoscopic Mucosal Resection vs Standard "Inject and Cut" Endoscopic Mucosal Resection for Large Colonic "Lateral Spreading Tumors" Treatment: a Randomized Multicentric Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of patients with residual lesions within 12 months.
研究概览
简要总结
"Lateral Spreading Tumors" (LSTs) are dysplastic lesions whose protrusion within the lumens the colon is not more than twice as compared to the surrounding non-dysplastic mucosa.
They can be divided into two groups:
Granular type (LST-G) and Non Granular type (LST-NG) Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are currently the most used techniques to resect this type of lesions. Compared to other methods of tissue ablation, EMR allows to carry out the histological evaluation of the resected fragments and ESD of the lesion in toto ("en bloc") EMR is currently the most used technique for removal of LST, but for lesions of ≥ 30 mm the resection is performed "piecemeal", i.e. fragmentary. This can compromise an adequate histological evaluation of the lateral and deep margins of the lesion.
Colonic EMR (EMR-S) is usually performed using a polypectomy snare, after lifting the lesion from the underlying layers with a submucosal injection of liquid (EMR standard or "inject-and-cut"). The aspiration of the lesion inside a plastic cap preloaded on the tip of the colonoscope ("cap-assisted EMR" - EMR-C) is almost exclusively used for the treatment of gastric and esophageal lesions. Its use for lesions of the colon and duodenum has been reported in limited experiences The principal aim of this study is to evaluate the efficacy and the safety of the EMR-C for the removal of large colonic LST-G and LST-NG, comparing it with EMR-S.
详细描述
Colorectal carcinoma (CRC) is the second cause of death for cancer in industrialized countries, with annual incidence and mortality of about one million and 500.000 case respectively.
It's well known that most of CRC follow the path adenoma-carcinoma: early diagnosis and endoscopic removal of colonic polyps has been proved to be useful in preventing cancer.
Most of colorectal polyps are smaller than 1 cm and can be successfully resected with a standard polypectomy. However, between 0.8% and 5% of patients develop sessile polyps or lesions larger than 20 mm, of which removal can be difficult, requiring high endoscopic experience.
Recent prospective studies report that 7%-36% of CRC have a flat or depressed morphology and are more likely to infiltrate the submucosa compared with polypoid ones.
A univariate analysis has proved that the size of the lesion is the only significant risk factor associated with malignant evolution.
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 (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 ≥18 years Colonic LST-G/NG () ≥ 30 mm in size. Patients able to undergo all follow up procedures as indicated in the protocol and to provide written informed consent, at least 48 hours before the intervention (reasoned consent).
排除标准
- •Presence of sessile polyps Non polypoid lesions 0-III according to Paris Classification Lesions with suspicion of malignancy (rigidity, non-lifting lesions, mucosal fragility, ulceration) Patients unable to provide informed consent Patients with coagulopathy and INR >1.5 (not corrected with replacement therapy, such as enoxaparin).
- •Patients who have undergone previous attempt of lesion resection (residual disease, local recurrence).
- •Patients with histological diagnosis of submucosal invading neoplasia who will be sent to surgery and excluded from follow-up.
研究组 & 干预措施
EMR-C group
A plastic cap for mucosectomy (MH-597, Olympus Optical Co., Ltd, Tokyo, Japan) with an outer diameter of 17 mm and a length of 15 mm will be preloaded on the tip of the colonoscope. Inside the distal end of the cap there is a gutter which positions the opened polypectomy snare.
After submucosal injection, the cap will be applied against the lesion which will be aspirated by "controlled suction", avoiding excessive protrusion of tissue in order not to trap the muscular layer.
The tissue will then be gripped with the snare and resection will be performed. A specific polypectomy snare which can be adapted into the gutter of the cap will be used (SD-221U-25, Olympus Optical Co., Ltd, Tokyo, Japan).
干预措施: cap for mucosectomy (Device)
EMR-S group
The resection will be performed using a standard polypectomy snare, which diameter will be chosen according to the size of the lesion, after lifting the lesion from the underlying layers with a submucosal injection of liquid.
干预措施: standard snare for polypectomy (Device)
结局指标
主要结局
Proportion of patients with residual lesions within 12 months.
时间窗: within 12 months
Patients with non invasive lesions will undergo follow-up colonoscopies at 3, 6, 12 months and thereafter annually after both EMR-C and EMR-S.. The presence of adenomatous tissue endoscopically visible at follow-up colonoscopies within the first year from EMR will be considered as residual lesion.
Proportion of patients with recurrence at 12 months.
时间窗: at 12 months
The presence of adenomatous tissue endoscopically visible after two previous negative colonoscopies will be defined as recurrence. "
次要结局
- Proportion of patients with early complications within 48 hours and late complications after 48 hours from both endoscopic procedures.(at the time of the procedure, within 48 hours, within 12 months)
研究者
Mario Marini
MD, Director of Gastroenterology and Operative Endoscopy Unit, Santa Maria Alle Scotte Hospital, Siena, Italy.
Azienda Ospedaliera Universitaria Senese