NCT05879783

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
20mo left

Started Sep 2022

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Sep 2022Dec 2027

Study Start

First participant enrolled

September 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Expected
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

May 19, 2023

Last Update Submit

August 21, 2023

Conditions

Colorectal Cancer

Keywords

Colorectal cancerConfocal laser endomicroscopyOptical biopsy

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Secondary Outcomes (2)

  • Sensitivity, specificity of pCLE optical biopsy

    7 days

  • The positive predictive value and negative predictive value of pCLE optical biopsy

    7 days

Study Arms (1)

Probe-based confocal laser endomicroscopy biopsy

EXPERIMENTAL

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

Diagnostic Test: Confocal laser endomicroscopy

Interventions

Confocal laser endomicroscopyDIAGNOSTIC_TEST

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

Probe-based confocal laser endomicroscopy biopsy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32405892BACKGROUND

  • 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.

    PMID: 26867984BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jun Yan, M.D., Ph.D.

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Yan, M.D., Ph.D.

CONTACT

086-13825066546yanjunfudan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 30, 2023

Study Start

September 15, 2022

Primary Completion

September 15, 2023

Study Completion (Estimated)

December 15, 2027

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)