NL-OMON22704招募中不适用
Ong-term onCologicAL outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC
Amsterdam University Medical Center, location AMC0 个研究点目标入组 153 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 153
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Patients meeting all of the following criteria will be invited for participation in the study:
- •-Recent polypectomy/(p)EMR/ESD of T1 CRC without the following histological high-risk features*:
- •oPoor differentiation
- •oLymphovascular invasion (NB if lymphovascular invasion cannot be assessed, patients are NOT eligible for inclusion)
- •oTumor budding grade 2/3 (NB if tumor budding cannot be assessed at histopathology, patients are NOT eligible for inclusion)
- •-This recent polypectomy/(p)EMR/ESD for T1 CRC resulted in positive resection margins < 0.1mm (R1) or indeterminate resection margins (Rx)
- •-The resection scar after polypectomy/EMR/ESD is clearly recognized at endoscopy, either by a tattoo or by detecting a scar in the colonic segment where no other polypectomies were performed
- •-The diameter of the original lesion was = 30 mm
- •-The diameter of the scar and/or residual lesion = 15 mm
- •-The interval between index polypectomy/EMR and additional eFTR is at most 12 weeks
- •-Staging computed tomography (CT) of thorax and abdomen is performed and no local lymph node or distant metastases are detected. In case of rectal location an additional magnetic resonance imaging (MRI) of the pelvis is performed and no local suspicious lymph node(s) detected. If the target lesion is visible on MRI, rectal location is defined as location distal from the sigmoid take off. If not visible on MRI, rectal location is defined as < 15 cm from anal verge on endoscopy.
- •-Written informed consent is provided
- •*Before inclusion in this study, eligible histology needs to be centrally revised by an expert gastrointestinal pathologist (either Dr. M. Lacle University Medical Center Utrecht or Dr. A. Farina Sarasqueta Amsterdam UMC). In case of any doubt on the presence of high-risk features, both expert pathologist will have a case discussion in order to make a statement on either the presence of these risk features or the indetermination of those.
排除标准
- •Patients meeting any of the following criteria will be excluded from participation in this study:
- •-If lymphovascular invasion and/or tumor budding grade 2/3 cannot be assessed after prior polypectomy/(p)EMR, patients are NOT eligible for inclusion
- •-The patient is known with at least one of the following conditions:
- •oActive inflammatory bowel disease (IBD) in the colon
- •oSynchronous advanced CRC (defined as CRC in the 5 years before detection of T1 CRC, or elsewhere in the colorectum at the time of detection of T1 CRC)
- •-Index lesion located < 5 cm of the anal verge or with involvement of the valvula Bauhini or appendiceal orifice
- •-Age < 18 years
- •-Pregnancy
研究者
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