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

NCT ID: NCT04634526

Last Updated: 2020-11-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2026-01-01

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.

Conditions

Liver Metastasis Colon Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncology Institute of Vojvodina

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mladjan Protic

Head of Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mladjan Protic

Role: PRINCIPAL_INVESTIGATOR

Oncology Institute of Vojvodina

Locations

Oncology Institute of Vojvodina

Kamenitz, , Serbia

Site Status: RECRUITING

Countries

Serbia

Central Contacts

Mladjan Protic, MD,PhD

Role: CONTACT

Phone: +381641253308

Email: mlprotic@gmail.com

Facility Contacts

Mladjan Protic

Role: primary

References

Protic M, Krsmanovic O, Solajic N, Kukic B, Nikolic I, Bogdanovic B, Radovanovic Z, Kresoja M, Mannion C, Man YG, Stojadinovic A. Prospective Non-Randomized Study of Intraoperative Assessment of Surgical Resection Margin of Colo-Rectal Liver Metastases. J Cancer. 2021 Apr 30;12(12):3701-3714. doi: 10.7150/jca.58580. eCollection 2021.

Reference Type: DERIVED

PMID: 33995645 (View on PubMed)

Other Identifiers

No 4/18/1-972-9

Identifier Type: -

Identifier Source: org_study_id