Rectal Cancer
Conditions
Keywords
rectal cancer, confocal laser endomicroscopy, optical biopsy
Brief 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.
Detailed description
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.
Interventions
DEVICEProbe-based confocal laser endomicroscopy targeted optical biopsy
After intravenous injection of fluorescein sodium, pCLE-based targeted optical biopsy will be performed.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age from over 18 to under 80 years 2. American Society of Anesthesiology(ASA) score class I,II,or III 3. Locally advanced rectal cancer 4. Patient has completed standard neoadjuvant therapy 5. Expected surgical resection 6. 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 allergic constitution
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of pCLE-targeted optical biopsy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity,specificity,positive predictive value and negative predictive value of pCLE targeted optical biopsy | 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. |
| Complications of biopsy | 7 days | Complications of biopsy, such as bleeding and drug allergies. |
Countries
China
Contacts
Primary ContactJun Yan, M.D., Ph.D.
Outcome results
None listed