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NCT Number: NCT05879783

Optical Biopsy for Peritoneal Nodules in Colorectal Patients

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Jun Yan, M.D.,Ph.D

CONTACT

[email protected]

086-13825066546

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Confocal laser endomicroscopy

Diagnostic Test

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

Primary outcomes

  1. Accuracy of pCLE optical biopsy

    Time frame: 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 outcomes

  1. Sensitivity, specificity of pCLE optical biopsy

    Time frame: 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.

  2. The positive predictive value and negative predictive value of pCLE optical biopsy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

086-13825066546

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
May 30, 2023
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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