Optical Biopsy for Peritoneal Nodules in Colorectal Patients

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05879783

Enrollment

278

Registered

2023-05-30

Start date

2022-09-15

Completion date

2027-12-15

Last updated

2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer, Confocal laser endomicroscopy, Optical biopsy

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.

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.

Interventions

DIAGNOSTIC_TESTConfocal laser endomicroscopy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

China

Contacts

Primary ContactJun Yan, M.D., Ph.D.

yanjunfudan@163.com086-13825066546

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026