Clinical trial · Observational
TRUS-FNA For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer
TRUS-FNA Versus MRI, CT, Enteroscopy, Superficial Biopsy, TRUS For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer
- 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)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EUS-FNA | — | UNRESOLVED | — |
| Pathological Complete Remission | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRUS-FNA | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Those patients with rectal cancer after neoadjuvant treatment and completed the examination of TRUS-FNA, TRUS, CT, MR, enteroscopy and superficial biopsy
- interventionNames
- Device: TRUS-FNA
Primary outcomes (1)
- measure
- the accuracy of predicting pCR after nCRT
- timeFrame
- 25/05/2021-25/05/2022
- description
- The primary endpoint was the predictive yield of TRUS-FNA for pathological complete responses after neoadjuvant treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * a new diagnosis of histologically confirmed rectal adenocarcinoma * tumor located below the peritoneum reflex * over 18 years old * T1-4,N0-2,M0 before nCRT * complete nCRT treatment * ASA\>III or ECOG\>1 * informed consent Exclusion Criteria: * multiple primary colorectal cancer * the history of malignant tumor,IBD,FAP * the history of chemoradiation treatment or resection of rectal tumor * actue abdomen disease requiring emergency surgery * not be able to tolerate surgery with severe organ dysfunction
References
Publications (0)
Data not yet available