Optical Biopsy for Peritoneal Nodules in Colorectal Patients

Colorectal Cancer Clinical Trial

Official title:

Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879783
• Other study ID #: NFEC-2023-088
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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