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

NCT04634526 | Unknown

• 1 other identifier: No 4/18/1-972-9
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Recurrence rate

  up to 5-years

• Disease free survival

  up to 5-years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Older than 18 years
• Preoperative diagnosis of liver metastases of colorectal adenocarcinoma
• Indication for surgical resection of liver metastases of colorectal adenocarcinoma

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncology Institute of Vojvodina: lead

Study Sites (1)

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

RECRUITING

Related Publications (1)

• 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.

  PMID: 33995645 DERIVED

Study Officials

• Mladjan Protic

  Oncology Institute of Vojvodina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mladjan Protic, MD,PhD

CONTACT

+381641253308; mlprotic@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Surgery

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 18, 2020
• Study Start: April 18, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2026
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

SE (1)