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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Metastasis Colon Cancer

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Mladjan Protic, MD,PhD; Phone Number: +381641253308; Email: mlprotic@gmail.com

Study Locations

• Serbia
  • Sremska Kamenica, Serbia, 21204
    • Recruiting
    • Oncology Institute of Vojvodina
    • Contact: Mladjan Protic; Email: mlprotic@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with liver resection for liver metastases or colo-rectal cancer

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	Percentage of patients with recurrence of disease	up to 5-years
Disease free survival	Time period from operation to the disease recurrence	up to 5-years

Collaborators and Investigators

• Sponsor: Oncology Institute of Vojvodina
• Investigators: Principal Investigator: Mladjan Protic, Oncology Institute of Vojvodina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: No 4/18/1-972-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No