Optical Biopsy for Peritoneal Nodules in Colorectal Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Confocal laser endomicroscopy.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery
Overview
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 test Confocal laser endomicroscopy
After intravenous injection of fluorescein sodium, pCLE-based optical biopsy will be performed.
Primary outcome measures
- Accuracy of pCLE optical biopsy [Time frame: 7 days]
Secondary outcome measures (2)
- Sensitivity, specificity of pCLE optical biopsy [Time frame: 7 days]
- The positive predictive value and negative predictive value of pCLE optical biopsy [Time frame: 7 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Nanfang Hospital, Southern Medical University — Guangzhou
Publications
- 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 32405892
- 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 26867984
Identifiers
NCT: NCT05879783 · NFEC-2023-088