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

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ClinicalTrials.gov Identifier: NCT04634526
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mladjan Protic, Oncology Institute of Vojvodina

Study Description
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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.

Condition or disease
Liver Metastasis Colon Cancer

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Clinical Study of Intraoperative Assessment of Resection Margin of Colo-Rectal Cancer Liver Metastases
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2026
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Rate of R1 cases assessed by surgeon [ Time Frame: at the operation ]
    Resection margin defined by surgeon could be negative (R0), positive without residual tumor (R1) and positive with residual tumor (R2)


Secondary Outcome Measures :
  1. Recurrence rate [ Time Frame: up to 5-years ]
    Percentage of patients with recurrence of disease

  2. Disease free survival [ Time Frame: up to 5-years ]
    Time period from operation to the disease recurrence


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients with liver resection for liver metastases or colo-rectal cancer
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634526


Contacts
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Contact: Mladjan Protic, MD,PhD +381641253308 mlprotic@gmail.com

Locations
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Serbia
Oncology Institute of Vojvodina Recruiting
Sremska Kamenica, Serbia, 21204
Contact: Mladjan Protic       mlprotic@gmail.com   
Sponsors and Collaborators
Oncology Institute of Vojvodina
Investigators
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Principal Investigator: Mladjan Protic Oncology Institute of Vojvodina
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mladjan Protic, Head of Department of Surgery, Oncology Institute of Vojvodina
ClinicalTrials.gov Identifier: NCT04634526    
Other Study ID Numbers: No 4/18/1-972-9
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases