RecruitingNot ApplicableNCT05316103

Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy

Use of Probe-based Confocal Laser Endomicroscopy to Perform Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

68 participants

Start Date

Nov 4, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Currently, low concordance (36%) is found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. Probe-based confocal laser endoscopy (pCLE) provides a promising targeted optical biopsy to evaluate the response to neoadjuvant chemoradiotherapy. The aim of this study is to investigate whether pCLE-targeted optical biopsy can improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • Age from over 18 to under 80 years
  • American Society of Anesthesiology(ASA) score class I,II,or III
  • Locally advanced rectal cancer
  • Patient has completed standard neoadjuvant therapy
  • Expected surgical resection
  • Written informed consent

Exclusion Criteria3

  • Pregnant or lactating women
  • Acute renal insufficiency or stage II to IV chronic renal insufficiency
  • Patients with allergic constitution

Interventions

DEVICEProbe-based confocal laser endomicroscopy targeted optical biopsy

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


Locations(1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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NCT05316103


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