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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

Tracking Information
First Submitted Date November 10, 2020
First Posted Date November 18, 2020
Last Update Posted Date November 18, 2020
Actual Study Start Date April 18, 2018
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 17, 2020)		 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 17, 2020)
  • Recurrence rate [ Time Frame: up to 5-years ]
    Percentage of patients with recurrence of disease
  • Disease free survival [ Time Frame: up to 5-years ]
    Time period from operation to the disease recurrence
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with liver resection for liver metastases or colo-rectal cancer
Condition Liver Metastasis Colon Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 17, 2020)		 250
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2026
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Mladjan Protic, MD,PhD +381641253308 mlprotic@gmail.com
Listed Location Countries Serbia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04634526
Other Study ID Numbers No 4/18/1-972-9
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Mladjan Protic, Oncology Institute of Vojvodina
Original Responsible Party Same as current
Current Study Sponsor Oncology Institute of Vojvodina
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Mladjan Protic Oncology Institute of Vojvodina
PRS Account Oncology Institute of Vojvodina
Verification Date November 2020