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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; EUS-FNA; Pathological Complete Remission
• Intervention / Treatment: Device: TRUS-FNA

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China
      • The Sixth Affiliate Hospital of Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all of the patients are from the sixth affiliated hospital of Sun Yet-sen University

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Those patients with rectal cancer after neoadjuvant treatment and completed the examination of TRUS-FNA, TRUS, CT, MR, enteroscopy and superficial biopsy	Device: TRUS-FNA; Transrectal Ultrasound Guided Fine Needle Aspiration for rectal tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the accuracy of predicting pCR after nCRT	The primary endpoint was the predictive yield of TRUS-FNA for pathological complete responses after neoadjuvant treatment.	25/05/2021-25/05/2022

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Study Chair: luo yanxin, MD,PHD, the sixth affiliated hospital of Sun Yet-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: luoyanxin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes