TRUS-FNA For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer

NCT04939103 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2022-09-01

No results posted yet for this study

Summary

Colorectal cancer is one of the most malignancies worldwide. The dominant clinical research strategy of LARC includes neoadjuvant chemoradiotherapy before radical surgery followed combined with adjuvant treatment. Approximately 15% to 20% of the patients after nCRT can achieve a pathologic complete response (pCR)---no residual tumor is reported at histology after a standard resection. Some researchers suggest that those patients with pCR can be spared the morbidities of surgery instead by a nonoperative approach---watch- and-wait(W\&W). However, neither FDG-PET, MRI, CT, nor enteroscopy can accurately determine a pCR.

EUS-FNA has been an important technique for the diagnosis of rectal cancer for its high accuracy and little harm. However, data on the TRUS-FNA for the cytologic diagnosis of pCR in rectal cancer is scarce. Our hypothesis is that adding transrectal ultrasound-guided fine needle aspiration (TRUS-FNA) compared with enteroscopy , MR, and CT alone can improve the accuracy of predicting pCR after nCRT.Therefore, the aim of the study is to assess the performance characteristics of EUS-FNA in this setting.

Conditions

Interventions

DEVICE

TRUS-FNA

Transrectal Ultrasound Guided Fine Needle Aspiration for rectal tumor

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • luo yanxin, MD,PHD · the sixth affiliated hospital of Sun Yet-Sen University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-06-01
Completion
2022-07-31
FDA Device
Yes

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939103 on ClinicalTrials.gov