Clinical trial NCT04634526: Prospective Clinical Study of Intraoperative Assessment of Resection Margin of Colo-Rectal Cancer Liver Metastases
Official title: Prospective Clinical Study of Intraoperative Assessment of Resection Margin of Colo-Rectal Cancer Liver Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Metastasis Colon Cancer
Lead sponsor: Oncology Institute of Vojvodina
Sponsor class: OTHER_GOV
First posted: 2020-11-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with liver resection for liver metastases or colo-rectal cancer

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.


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

Primary outcomes:
measure: Rate of R1 cases assessed by surgeon
timeFrame: at the operation
Secondary outcomes:
measure: Recurrence rate
timeFrame: up to 5-years
measure: Disease free survival
timeFrame: up to 5-years
Other outcomes:
Locations:
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
Study officials:
affiliation: Oncology Institute of Vojvodina
name: Mladjan Protic
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.