Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
NCT Number: NCT05316103
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
Patients with locally advanced rectal cancer can benefit from neoadjuvant chemoradiotherapy, and 20%-30% of patients receiving such therapy can attain a pathologic complete response, defined as the eradication of cancer cells. For those who reach pathologic complete response, a watch-and-wait strategy is supposed to be the best choice. However, low concordance (36%) was found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. There is a compelling need to improve the consistency.
Probed-based confocal laser endoscopy (pCLE) is a novel endoscopic adjunct that allows 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. It provides a promising targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.
The investigators perform this study to investigate whether pCLE-targeted optical biopsy could improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy. In this study, rectal cancer patients after neoadjuvant chemoradiotherapy will be successively arranged to accept traditional endoscopic biopsy and pCLE-based targeted optical biopsy. The consistency rate will be calculated according to the postoperative pathological results.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After intravenous injection of fluorescein sodium, pCLE-based targeted optical biopsy will be performed.
Time frame: 7 days
The investigators will use pCLE-targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
Time frame: 7 days
The investigators will use pCLE-targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
Time frame: 7 days
Complications of biopsy, such as bleeding and drug allergies.
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
Use of Probe-based Confocal Laser Endomicroscopy to Perform Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
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