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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05879783
Other study ID # NFEC-2023-088
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date December 15, 2027

Study information

Verified date August 2023
Source Nanfang Hospital, Southern Medical University
Contact Jun Yan, M.D., Ph.D.
Phone 086-13825066546
Email yanjunfudan@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 278
Est. completion date December 15, 2027
Est. primary completion date September 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Confocal laser endomicroscopy
After intravenous injection of fluorescein sodium, pCLE-based optical biopsy will be performed.

Locations

Country Name City State
China Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Al-Mansour MR, Caycedo-Marulanda A, Davis BR, Alawashez A, Docimo S, Qureshi A, Tsuda S. SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy. Surg Endosc. 2021 May;35(5):2091-2103. doi: 10.1007/s00464-020-07607-3. Epub 2020 May 13. — View Citation

Baratti D, Kusamura S, Pietrantonio F, Guaglio M, Niger M, Deraco M. Progress in treatments for colorectal cancer peritoneal metastases during the years 2010-2015. A systematic review. Crit Rev Oncol Hematol. 2016 Apr;100:209-22. doi: 10.1016/j.critrevonc.2016.01.017. Epub 2016 Jan 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of pCLE optical biopsy 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. 7 days
Secondary Sensitivity, specificity of pCLE optical biopsy 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. 7 days
Secondary The positive predictive value and negative predictive value of pCLE optical biopsy 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. 7 days
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