Follow-up Protocol of Colorectal Endoscopic Mucosal Resection Scars: a Multicentre Randomized Single-blinded Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Diagnostic performance of WLE and NBI for each group
研究概览
简要总结
Nowadays endoscopic mucosal resection (EMR) is the gold standard for the removal of large laterally spreading and sessile colorectal lesions ≥ 20 mm. However, recurrence rate after successful EMR (defined by the absence of neoplastic tissue at the completion of the procedure after careful inspection of the post-EMR mucosal defect and margin) is about 15-20%. Consequently, current guidelines recommend a surveillance colonoscopy between 4 and 6 months after resection for detection of residual or recurrent polyp.
There are few studies that have examined the accuracy of advanced endoscopic imaging for the prediction of histological recurrence but none of these imaging modalities have been validated for surveillance after EMR. Therefore, current guidelines strongly recommend systematic biopsy of EMR scar.
The main aim of this study is to assess the incremental benefit of narrow band imaging (NBI) and white light endoscopy (WLE) randomizing the initial technique for the endoscopic detection of post-EMR recurrence and to asses if this advanced imaging method achieve sufficient diagnostic accuracy to exclude recurrence without the need for biopsy.
详细描述
a. Study type: multicenter randomized crossover trial: i. prospective inclusion of consecutive patients undergoing first follow-up surveillance colonoscopy after successful EMR of colorectal lesion; ii. crossover randomization by computer generated tables; iii. allocation concealment by sealed, opaque envelopes; iv. pathologist-blinded - pathologists are blinded to the study protocol and samples are received as 'EMR scar for assessment' .
b. Selection patient method: inclusion by invitation of patients undergoing the first follow-up surveillance colonoscopy after successful EMR of colorectal lesion.
c. Sample size: 210 (two groups of 105 patients). To improve accuracy from 85% (value obtained by a study that did not show significant differences in the accuracy of NBI followed by WLE vs. WLE followed by NBI) to 95% and assuming a normal distribution and a power of 80% (α=0.05), the calculated sample size of each of the 2 groups was 96; allowing for a 10% dropout rate, the sample size is 105 per group (210 patients overall).
d. Procedures and data collection methods: i. Each procedure is performed by the same endoscopist. ii. All patients receive split dose bowel preparation. iii. All colonoscopies are performed using high definition colonoscopes with NBI ( EVIS EXERA III CV 185 and CV 190; Olympus Inc., Tokyo, Japan). iv. Colon inspection is done with WLE during withdrawal. v. At the proximity of the scar WLE and NBI were used randomly one after the other (WLE>NBI or NBI>WLE). If NBI is the first technique used, it is switched prior to scar detection, avoiding, as far as possible, a glance with WLE. The edges of the scar are interrogated followed by the centre of the scar and finding are recorded. vi. After both evaluations, if there is no suspicion of recurrence, the site is sampled by at least 2 biopsies of the scar edge. If there is any suspicion of recurrence, tissue sample is obtained and then treated by endoscopic resection using standard methods. At least 2 biopsies specimens from normal appearing scar are also obtained.
e. Analysed variables: i. patient characteristics; ii. data from baseline colonoscopy; iii. data from first surveillance colonoscopy (see outcome measures).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
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 undergoing the first follow-up surveillance colonoscopy after successful EMR of colorectal lesion.
排除标准
- •informed consent not provided,
- •inflammatory bowel disease, inadequate bowel preparation (Boston Bowel Preparation Scale total score < 6 or < 2 in a segment),
- •EMR scar not identified during colonoscopy,
- •tissue acquisition unfeasibly.
结局指标
主要结局
Diagnostic performance of WLE and NBI for each group
时间窗: 1 day (at the time of data analysis)
Sensitivity, specificity, negative predictive value, positive predictive value and accuracy of NBI and WLE for each group calculated using 2x2 contingency tables
Recurrent adenoma - WLE
时间窗: 1 day (during colonoscopy)
WLE recurrent adenoma identification for each group
Recurrent adenoma - NBI
时间窗: 1 day (during colonoscopy)
NBI recurrent adenoma identification for each group
Recurrent adenoma - histology
时间窗: 1 day (within 30 days from colonoscopy)
Adenoma recurrence confirmed by histology
次要结局
- Lesion characterization at the baseline colonoscopy(1 day (at the time of patient inclusion))
- Scar characterization at the first surveillance colonoscopy(1 day (immediately after first surveillance colonoscopy))
研究者
Mafalda Cainé João
Medical Doctor
Portuguese Oncology Institute, Coimbra