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Optical Biopsy for Peritoneal Nodules in Colorectal Patients

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Confocal laser endomicroscopy
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colorectal cancer, Confocal laser endomicroscopy, Optical biopsy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age from over 18 to under 85 years American Society of Anesthesiology (ASA) score class I,II,or III Colorectal cancer Patients who be about to undergo surgical treatment Written informed consent Exclusion Criteria: Pregnant or lactating women Acute renal insufficiency or stage II to IV chronic renal insufficiency Patients with severe liver damage Asthma patients or patients with allergic constitution

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probe-based confocal laser endomicroscopy biopsy

Arm Description

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

Outcomes

Primary Outcome Measures

Accuracy of pCLE optical biopsy
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

Sensitivity, specificity of pCLE optical biopsy
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
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.

Full Information

First Posted
May 19, 2023
Last Updated
August 21, 2023
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05879783
Brief Title
Optical Biopsy for Peritoneal Nodules in Colorectal Patients
Official Title
Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
December 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Confocal laser endomicroscopy, Optical biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probe-based confocal laser endomicroscopy biopsy
Arm Type
Experimental
Arm Description
In this study , pCLE-based optical biopsy will be successively performed for peritoneal nodules in colorectal cancer patients during surgical operation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Confocal laser endomicroscopy
Intervention Description
After intravenous injection of fluorescein sodium, pCLE-based optical biopsy will be performed.
Primary Outcome Measure Information:
Title
Accuracy of pCLE optical biopsy
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Sensitivity, specificity of pCLE optical biopsy
Description
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.
Time Frame
7 days
Title
The positive predictive value and negative predictive value of pCLE optical biopsy
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from over 18 to under 85 years American Society of Anesthesiology (ASA) score class I,II,or III Colorectal cancer Patients who be about to undergo surgical treatment Written informed consent Exclusion Criteria: Pregnant or lactating women Acute renal insufficiency or stage II to IV chronic renal insufficiency Patients with severe liver damage Asthma patients or patients with allergic constitution
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Yan, M.D., Ph.D.
Phone
086-13825066546
Email
yanjunfudan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Yan, M.D., Ph.D.
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Yan, M.D.,Ph.D
Phone
086-13825066546
Email
yanjunfudan@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32405892
Citation
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.
Results Reference
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PubMed Identifier
26867984
Citation
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.
Results Reference
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Optical Biopsy for Peritoneal Nodules in Colorectal Patients

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