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

Recruiting

• Conditions: Liver Metastasis Colon Cancer

• Registration Number: NCT04634526
• Lead Sponsor: Oncology Institute of Vojvodina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-18
• Status Verified: 2020-11
• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-17
• Last Update Submitted: 2020-11-17
• Study First Posted: 2020-11-18
• Last Update Posted: 2020-11-18
• Primary Completion: 2021-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of R1 cases assessed by surgeon	at the operation	Resection margin defined by surgeon could be negative (R0), positive without residual tumor (R1) and positive with residual tumor (R2)

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	up to 5-years	Percentage of patients with recurrence of disease
Disease free survival	up to 5-years	Time period from operation to the disease recurrence

Trial Locations

Locations (1)

Oncology Institute of Vojvodina; 🇷🇸 Sremska Kamenica, Serbia