The Sensitivity of Scar-biopsies for Residual Colorectal Adenocarcinoma After Endoscopic Resection With Uncertain Radicality
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 246
- 试验地点
- 72
- 主要终点
- Sensitivity of biopsies for residual cancer
研究概览
简要总结
After endoscopic removal of a colorectal polyp that harbors (unexpected) adenocarcinoma, pathology usually can not guarantee a radical resection from an oncological point of view. In such case, additional surgical resection is advised. However, only in 15% of patients, residual adenocarcinoma is found. This study investigates the sensitivity of biopsies from the polypectomy scar for residual adenocarcinoma.
详细描述
Rationale: colorectal polyps may harbor adenocarcinoma. Numbers are increasing due to the nationwide colorectal screening program. After endoscopic removal, rescue surgery is often performed because radicality can not be guaranteed by the pathologist. However, in 85% of surgical specimen no residual malignancy is found. Given morbidity and mortality associated with surgery a method to diagnose residual cancer is needed.
Biopsies from the polypectomy site are variably used to reduce the likelihood of residual tumor at the polypectomy site under these circumstances. However, the sensitivity of such biopsies is unknown.
Objective: to evaluate the sensitivity of second-look endoscopic biopsies from the polypectomy site for residual tumor.
Study design: prospective cross-sectional design using a multi-center approach. Study population: patients planned for rescue surgery for the sole reason of (potentially) irradical endoscopic resection of a colorectal adenocarcinoma without poor differentiation, lymphovascular invasion or tumor budding and without other signs of dissemination.
Intervention: endoscopic biopsies from the polypectomy site before operation. Main study parameters/endpoints: sensitivity of second-look biopsies from the polypectomy site for residual tumor in the resected bowel and postoperative mortality. Various other factors will be assessed that might be associated with residual cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Aged 18 or above.
- •Endoscopically removed colorectal lesion with the following pathological characteristics:
- •A moderately-to-well differentiated adenocarcinoma.
- •If possible to judge: distance between adenocarcinoma and vertical or lateral resection margin is less than 1 mm.
- •In case of piecemeal resection: unjudgeable radicality (mostly due to loss of orientation and multiple fragments).
- •Absence of / unjudgeable lymphatic / vascular invasion.
- •No or only grade I tumor budding.
- •No suspicion of dissemination on the following investigations: serum carcino-embryonic antigen, a computer tomographic (CT) scan of the abdomen and a chest X-ray; in case of a rectal tumor (less than 15 cm from the anal verge): an additional magnetic resonance imaging of the rectum.
- •Operation is advised in agreement with the Dutch Guideline on Colorectal cancer, planned and agreed on by the patient.
- •Written informed consent is obtained.
排除标准
- •Pathology shows one or more of the following characteristics:
- •A radical en-bloc resection with a free vertical and lateral margin of ≧ 1 mm.
- •A poorly differentiated or signet-cell containing adenocarcinoma.
- •Lymphatic or vascular invasion (if this feature is unjudgeable due to piecemeal resection, no exclusion is done).
- •Tumor budding grade II-III.
- •Suspicion of dissemination on investigations as mentioned in the inclusion criteria.
- •Patients already receiving anti-tumor treatment for another tumor or a synchronic colorectal cancer.
- •Patients in whom a second-look endoscopy would require major and unacceptable effort and / or resources, for instance clinical admission for bowel preparation, long travel, general anesthesia, extremely difficult to reach polypectomy site. Such at the decision of the patient and / or treating physician.
- •Patient is planned for trans-anal surgery.
- •Patient is not planned for surgery.
- •Patient is pregnant.
- •Patient does not provide written informed consent or is unable to provide such.
结局指标
主要结局
Sensitivity of biopsies for residual cancer
时间窗: up to 1 year
The number of patients with endoscopic biopsies containing adenocarcinoma divided by the number of patients with adenocarcinoma in the resected specimen.
次要结局
- 90-day mortality after rescue surgery(91 days from surgery)
- The sensitivity of biopsies for residual cancer in the bowel wall(up to 1 year)
- The number of complications (defined according to GCP) after biopsies from the polypectomy scar(up to 30 days)
- The sensitivity of global endoscopic assessment of polypectomy site for residual cancer at initial and follow-up endoscopy (to take scar biopsies)(up to 1 year)
- The proportion of patients with residual cancer in the resected specimen if malignancy was unsuspected during the endoscopic polypectomy(up to 1 year)
研究者
Dr. Frank ter Borg MD PhD
MD PhD, Gastroenterologist
Deventer Ziekenhuis