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临床试验/NCT04634526
NCT04634526招募中不适用

Prospective Clinical Study of Intraoperative Assessment of Resection Margin of Colo-Rectal Cancer Liver Metastases

Oncology Institute of Vojvodina1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
Rate of R1 cases assessed by surgeon

研究概览

简要总结

This prospective single arm double-blind study approved by the Ethics Committee of the institution, will be conducted on at the Oncology Institute of Vojvodina in Sremska Kamenica, Serbia. Patients with colo-rectal cancer liver metastases (CRLM) is presented to the multi-disciplinary team (MDT).Screening and enrolment is conducted after established of indication for resection. The surgeons assesses resection margin (RM) for every resected liver specimen (RLS) intra-operatively by inspection and palpation. These data will be compared with pathological RM examination as a "gold standard". Resection margin of 1 mm or more will be rated as negative RM (RM-) otherwise RM is positive (RM+). Taking the result of the pathohistological examination as "gold standard" it is determined that RM is true positive when the pathologist and surgeon agreed that the RM is positive. False negative RM is when the surgeon assesses RM as negative and pathologist as positive. The sensitivity of the surgical assessment of RM+ is defined as the rate of RM+ which was correctly identified. True negative RM is determined when the pathologist and surgeon agreed that it is negative RM. False positive RM defined when the surgeon assessed RM as positive, but pathologist found that it was RM-. The specificity of the surgical assessment of RM is defined as the rate of RM- which is correctly identified. Total accuracy represents the rate of correctly recognized positive and negative RM, relative to the total number of samples. Agreement between surgeon and pathologists finding will be analyzed as well as difference between them. Disease recurrence and disease-free survival (DFS) will be analyzed by RM.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years
  • Preoperative diagnosis of liver metastases of colorectal adenocarcinoma
  • Indication for surgical resection of liver metastases of colorectal adenocarcinoma

排除标准

  • RM is not defined by surgeons and pathologists as positive or negative
  • Surgical resections and application of ablative procedures at the same time
  • Surgery for relapse of CRLM, if the first CRLM surgery is performed before this study start
  • Resection was not done from any reason

结局指标

主要结局

Rate of R1 cases assessed by surgeon

时间窗: at the operation

Resection margin defined by surgeon could be negative (R0), positive without residual tumor (R1) and positive with residual tumor (R2)

次要结局

  • Recurrence rate(up to 5-years)
  • Disease free survival(up to 5-years)

研究者

发起方
Oncology Institute of Vojvodina
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mladjan Protic

Head of Department of Surgery

Oncology Institute of Vojvodina

研究点 (1)

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