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

Liver Metastasis Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04634526
• Other study ID #: No 4/18/1-972-9
• Status: Recruiting
• Start date: April 18, 2018
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2020
• Source: Oncology Institute of Vojvodina
• Contact: Mladjan Protic, MD,PhD
• Phone: +381641253308
• Email: mlprotic[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2021
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
Serbia	Oncology Institute of Vojvodina	Sremska Kamenica

Sponsors (1)

Lead Sponsor	Collaborator
Oncology Institute of Vojvodina

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence rate	Percentage of patients with recurrence of disease	up to 5-years
Secondary	Disease free survival	Time period from operation to the disease recurrence	up to 5-years