Optical Biopsy for Peritoneal Nodules in Colorectal Patients

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Diagnostic Test: Confocal laser endomicroscopy

• Registration Number: NCT05879783
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-05-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23
• Primary Completion: 2023-09-15
• Study Completion: 2027-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probe-based confocal laser endomicroscopy biopsy	Confocal laser endomicroscopy	In this study , pCLE-based optical biopsy will be successively performed for peritoneal nodules in colorectal cancer patients during surgical operation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China