Using optical biopsy to diagnose peritoneal nodules in colorectal cancer patients during surgery
Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery
This study is testing a new way to quickly check for cancer spread in the abdomen during surgery for colorectal cancer patients using a special imaging technique.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 278 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05879783 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the diagnosis of peritoneal metastasis in colorectal cancer patients by utilizing confocal laser endomicroscopy (pCLE) during surgical procedures. The approach allows for real-time, in vivo histological examination of suspected peritoneal nodules, potentially reducing the time taken for pathological confirmation. By using intravenous fluorescent agents, pCLE enhances the visibility of mucosal elements, facilitating an optical biopsy that can provide immediate diagnostic results. This method seeks to streamline the surgical process and improve patient outcomes by enabling quicker decision-making during surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 with colorectal cancer who are scheduled for surgical treatment.
Not a fit: Patients who are pregnant, have severe liver damage, or significant renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the time required for diagnosing peritoneal metastasis, leading to more timely surgical interventions.
How similar studies have performed: While the use of confocal laser endomicroscopy is a novel approach in this context, similar techniques have shown promise in other areas of cancer diagnosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age from over 18 to under 85 years 2. American Society of Anesthesiology (ASA) score class I,II,or III 3. Colorectal cancer 4. Patients who be about to undergo surgical treatment 5. Written informed consent Exclusion Criteria: 1. Pregnant or lactating women 2. Acute renal insufficiency or stage II to IV chronic renal insufficiency 3. Patients with severe liver damage 4. Asthma patients or patients with allergic constitution
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Jun Yan, M.D., Ph.D. — Nanfang Hospital, Southern Medical University
- Study coordinator: Jun Yan, M.D., Ph.D.
- Email: yanjunfudan@163.com
- Phone: 086-13825066546
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.