Optical Biopsy for Peritoneal Nodules in Colorectal Patients

• Sponsor: Nanfang Hospital of Southern Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05879783
• Collaborator: (none)
• Enrollment: 278
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 18.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Diagnostic Test: Confocal laser endomicroscopy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 278 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery
• Actual Study Start Date: Sep 15, 2022
• Anticipated Primary Completion Date: Sep 15, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probe-based confocal laser endomicroscopy biopsy In this study , pCLE-based optical biopsy will be successively performed for peritoneal nodules in colorectal cancer patients during surgical operation.	Diagnostic Test: Confocal laser endomicroscopy; After intravenous injection of fluorescein sodium, pCLE-based optical biopsy will be performed.

Outcome Measures

Primary Outcome Measures

1. Accuracy of pCLE optical biopsy [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 Outcome Measures

1. Sensitivity, specificity of pCLE optical biopsy [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.

2. The positive predictive value and negative predictive value of pCLE optical biopsy [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

• Nanfang Hospital of Southern Medical University

Investigators

• Principal Investigator: Jun Yan, M.D., Ph.D., Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Nanfang Hospital of Southern Medical University
• ClinicalTrials.gov Identifier: NCT05879783
• Other Study ID Numbers: NFEC-2023-088
• First Posted: May 30, 2023
• Last Update Posted: May 30, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nanfang Hospital of Southern Medical University: Colorectal cancer; Confocal laser endomicroscopy; Optical biopsy
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of May 30, 2023