Assessing surgical margins in liver metastases from colorectal cancer during surgery
Prospective Clinical Study of Intraoperative Assessment of Resection Margin of Colo-Rectal Cancer Liver Metastases
This study is testing how well surgeons can check the edges of liver tumors during surgery for colorectal cancer to see if their findings match what the lab says afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Oncology Institute of Vojvodina Government |
| Locations | 1 site (Sremska Kamenica) |
| Trial ID | NCT04634526 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the accuracy of intraoperative assessment of resection margins in patients undergoing surgery for liver metastases from colorectal cancer. Patients will be enrolled after a multidisciplinary team determines the need for surgical resection. Surgeons will assess the resection margins during the operation, and these assessments will be compared to the pathological examination results post-surgery, which serve as the gold standard. The goal is to determine the sensitivity of the surgical assessment in identifying positive and negative margins.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a preoperative diagnosis of liver metastases from colorectal adenocarcinoma who are indicated for surgical resection.
Not a fit: Patients who have undefined resection margins or those undergoing simultaneous surgical resections and ablative procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes by ensuring more accurate assessments of cancer resection margins, potentially reducing the risk of cancer recurrence.
How similar studies have performed: While similar studies have explored intraoperative assessments, this specific approach to evaluating resection margins in colorectal liver metastases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sremska Kamenica
- Oncology Institute of Vojvodina — Sremska Kamenica, Serbia (Recruiting)
Study contacts
- Principal investigator: Mladjan Protic — Oncology Institute of Vojvodina
- Study coordinator: Mladjan Protic, MD,PhD
- Email: mlprotic@gmail.com
- Phone: +381641253308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.