Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 278
- Locations
- 1
- Primary Endpoint
- Accuracy of pCLE optical biopsy
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
During surgery, peritoneal metastasis is typically confirmed pathologically through resection sample. However, this process can be time-consuming when utilizing intro-operative frozen section pathology. To address this issue, we propose utilizing confocal laser endomicroscopy to provide in situ, real-time, and in-vivo diagnosis of suspected peritoneal nodules as cancer metastasis during surgery.
Detailed Description
Peritoneal metastasis is a common metastatic site in colorectal cancer patients, and those with peritoneal metastasis often have a poor prognosis. During surgery, peritoneal metastasis is confirmed pathologically through resection sample, but frozen section pathology can take up to 30 minutes, which is a significant amount of time. To address this issue, we suggest utilizing probed-based confocal laser endoscopy (pCLE), a novel endoscopic adjunct that enables real-time in vivo histological examination of mucosal surfaces. By using intravenous fluorescent agents, pCLE highlights certain mucosal elements that facilitate an optical biopsy in real time. By providing a promising optical biopsy, CLE has the potential to enable in situ, real-time, and in vivo diagnosis of colorectal cancer patients with peritoneal nodules during surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age from over 18 to under 85 years
- •American Society of Anesthesiology (ASA) score class I,II,or III
- •Colorectal cancer
- •Patients who be about to undergo surgical treatment
- •Written informed consent
Exclusion Criteria
- •Pregnant or lactating women
- •Acute renal insufficiency or stage II to IV chronic renal insufficiency
- •Patients with severe liver damage
- •Asthma patients or patients with allergic constitution
Outcomes
Primary Outcomes
Accuracy of pCLE optical biopsy
Time Frame: 7 days
The investigators will use pCLE optical biopsy for peritoneal nodules in colorectal cancer patients and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
Secondary Outcomes
- Sensitivity, specificity of pCLE optical biopsy(7 days)
- The positive predictive value and negative predictive value of pCLE optical biopsy(7 days)