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- Ensayo clínico NCT04939103
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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Following the neoadjuvant treatment of rectal cancer, appropriately 15-20%of patients receiving neoadjuvant treatment can achieve pathological complete response: a condition of no tumor cell detected in surgical specimens, which usually suggests improved oncology outcomes. In 2004, Habr-Gama, A et al. proposed that surgical resection may not increase overall and disease-free survival in these patients and lead to an increased risk of surgical complications and permanent stoma. Therefore, they suggested that nonoperative treatment, which is now referred to as "watch-and-wait"--patients with clinical complete response (cCR) can avoid unnecessary surgery and be managed by strict follow-up and observation alone. A series of studies have shown impressive survival outcomes in patients who received nonoperativetreatment:85-93% and 82-94% in 5-year overall survival and disease-free survival, respectively. Also, in case of relapse, the rate of successfully performed salvage surgery was 80-91%.
However, determining pCR after neoadjuvant treatment for distal rectal cancer remains a dilemma for clinicians. Different imaging modalities, including digital rectal examination (DRE), fludeoxyglucose positron emission tomography (FDG-PET), Computed Tomography (CT), magnetic resonance imaging (MRI), transrectal ultrasound (TRUS) and endoscopy have been well evaluated for the efficacy of predicting pCR. In contrast, none of them proved to be reliable.
Duldulao et al. found that after neoadjuvant treatment, rectal tumor cells are distributed preferentially in the muscularis of the bowel wall while few in the mucosa. That is why superficial biopsies were inadequate, and full-thickness apparitions on tumor focus may provide adequate sampling to rule out malignancy for all stages of rectal cancer after neoadjuvant treatment. Therefore, fine-needle aspiration assisted with TRUS (TRUS-FNA), which can harvest a whole layer of the bowel wall, has shown obvious advantages in this setting.
Although widely used in clinical practice, studies regarding the application of TRUS-FNA in predicting pCR after preoperative therapy of rectal cancer were scarce. We hypothesized that TRUS-FNA could improve the clinical practice of identifying patients achieving pCR after neoadjuvant treatment. Accordingly, we conducted this prospective study to evaluate the efficacy of TURS-FNA, compared with other imaging modalities, TRUS, MRI, CT, enteroscopy, and superficial biopsy, in predicting pCR of rectal cancer after neoadjuvant treatment.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangdong
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GuangZhou, Guangdong, Porcelana
- The Sixth Affiliate Hospital of Sun Yat-Sen University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Those patients with rectal cancer after neoadjuvant treatment and completed the examination of TRUS-FNA, TRUS, CT, MR, enteroscopy and superficial biopsy
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Transrectal Ultrasound Guided Fine Needle Aspiration for rectal tumor
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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the accuracy of predicting pCR after nCRT
Periodo de tiempo: 25/05/2021-25/05/2022
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The primary endpoint was the predictive yield of TRUS-FNA for pathological complete responses after neoadjuvant treatment.
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25/05/2021-25/05/2022
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: luo yanxin, MD,PHD, the sixth affiliated hospital of Sun Yet-Sen University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
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Otros números de identificación del estudio
- luoyanxin
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Cáncer de recto
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ColubrisMXActivo, no reclutandoPólipo rectal | Lesión rectal | Adenoma rectalEstados Unidos
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Groupe Hospitalier Paris Saint JosephTerminado
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Technische Universität DresdenReclutamiento
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Instituto de Investigación Hospital Universitario...ReclutamientoCirugía Rectal OncológicaEspaña
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Arrowhead Regional Medical CenterTerminadoCuerpo extraño rectal | Perforación rectal | Perforación colónicaEstados Unidos
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Assistance Publique - Hôpitaux de ParisReclutamientoTransporte rectal de enterobacterias productoras de carbapenemasasFrancia
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Université de SherbrookeTerminadoDisfunción sexual | Satisfacción del paciente | Cirugia Rectal
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Stanford UniversityCaring for Carcinoid Foundation; GI Cancer Research Gift FundRetiradoNeoplasias Gastrointestinales | Cancer de pancreas | Cáncer de ano | Cáncer de colon/rectal | Cánceres hepatobiliares | Cáncer gástrico (de estómago) | Cánceres ginecológicos | Cáncer de la unión gastroesofágica (GE) | Cánceres ginecológicos Cáncer de cuello uterino | Tumor del estroma gastrointestinal... y otras condicionesEstados Unidos
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University Hospital OstravaTerminadoCirugía Abdominal Mayor | Duodenohemipancreatectomía | Resección rectal | Cirugía Intestinal ExtensaRepública Checa
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Mansoura UniversityTerminadoProlapso rectal completoEgipto
Ensayos clínicos sobre TRUS-FNA
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University of DundeeNHS Tayside; Chief Scientist Office of the Scottish Government; Prostate Cancer UK y otros colaboradoresTerminadoCancer de prostataReino Unido
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Johns Hopkins UniversityTerminado
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Saskatchewan Health Authority - Regina AreaTerminado
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Institut Paoli-CalmettesExact ImagingDesconocido
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AdventHealthUniversity of Alabama at BirminghamTerminado
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Amphia HospitalDesconocidoCancer de prostataPaíses Bajos
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University of Colorado, DenverUS EndoscopyReclutamientoQuiste pancreáticoEstados Unidos
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American Society for Gastrointestinal EndoscopyMidwest Biomedical Research FoundationDesconocidoAdenopatías mediastínicas o intraabdominales, | Masas pancreáticas, | Masas Suprarrenales Izquierdas, | Lesiones submucosas gastrointestinales, y | Masas hepáticasEstados Unidos
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Duke UniversityEigenReclutamiento