To hear about similar clinical trials, please enter your email below
Trial Title:
Optical Biopsy for Peritoneal Nodules in Colorectal Patients
NCT ID:
NCT05879783
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal cancer
Confocal laser endomicroscopy
Optical biopsy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Confocal laser endomicroscopy
Description:
After intravenous injection of fluorescein sodium, pCLE-based optical biopsy will be
performed.
Arm group label:
Probe-based confocal laser endomicroscopy biopsy
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Yan, M.D.,Ph.D
Phone:
086-13825066546
Email:
yanjunfudan@163.com
Start date:
September 15, 2022
Completion date:
December 15, 2027
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05879783
