Clinical trial · Interventional
Optical Biopsy for Peritoneal Nodules in Colorectal Patients
Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal laser endomicroscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Probe-based confocal laser endomicroscopy biopsy
- description
- In this study , pCLE-based optical biopsy will be successively performed for peritoneal nodules in colorectal cancer patients during surgical operation.
- interventionNames
- Diagnostic Test: Confocal laser endomicroscopy
Primary outcomes (1)
- measure
- Accuracy of pCLE optical biopsy
- timeFrame
- 7 days
- 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.
Secondary outcomes (2)
- measure
- Sensitivity, specificity of pCLE optical biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDAl-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
- BACKGROUNDBaratti 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