Optical Biopsy for Peritoneal Nodules in Colorectal Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2027-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Confocal laser endomicroscopy

Intervention Type DIAGNOSTIC_TEST

After intravenous injection of fluorescein sodium, pCLE-based optical biopsy will be performed.

Interventions

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Confocal laser endomicroscopy

After intravenous injection of fluorescein sodium, pCLE-based optical biopsy will be performed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No