NCT04634526

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

Status unknown Last updated 18 November 2020

What this trial tests

trial in Liver Metastasis Colon Cancer in 250 participants. Status unknown.

Timeline

18 April 2018

Primary endpoint
1 January 2021

1 January 2026

Quick facts

Lead sponsor	Oncology Institute of Vojvodina
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	250
Start date	18 April 2018
Primary completion	1 January 2021
Estimated completion	1 January 2026
Sites	1 location across Serbia

Conditions studied

• Liver Metastasis Colon Cancer — all drugs for Liver Metastasis Colon Cancer →

Sponsor

Oncology Institute of Vojvodina

Who can join

Adults 18 to 85, any sex, with Liver Metastasis Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prospective Non-Randomized Study of Intraoperative Assessment of Surgical Resection Margin of Colo-Rectal Liver Metastases.
   Protic M, Krsmanovic O, Solajic N, Kukic B, et al · · 2021 · cited 5× · PMID 33995645 · DOI 10.7150/jca.58580