Optical Biopsy for Peritoneal Nodules in Colorectal Patients

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Diagnostic Test: Confocal laser endomicroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05879783

NFEC-2023-088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 278 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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278 participants in 1 patient group

Probe-based confocal laser endomicroscopy biopsy

Experimental group

Description:

In this study , pCLE-based optical biopsy will be successively performed for peritoneal nodules in colorectal cancer patients during surgical operation.

Treatment:

Diagnostic Test: Confocal laser endomicroscopy