Analysis of Extraperitoneal Rectal Neoplasms Between 3D Endorectal Ultrasonography and Magnification Chromoendoscopy

Rectal Cancer Clinical Trial

Official title:

Results of the Comparative Analysis of Invasion Depth of Extraperitoneal Rectal Neoplasms Between Three-dimensional Endorectal Ultrasonography and Magnification Chromoendoscopy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04527939
• Other study ID #: 9076079
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: August 7, 2023

Study information

• Verified date: August 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ERUS-3D and CMI demonstrated good diagnostic accuracy in parietal staging of rectal extraperitoneal neoplasms, however with greater efficiency of the endoscopic method. The association of studies can improve diagnostic efficacy and influence the most appropriate approach.

Description:

Larger lesions present less chance of deep parietal invasion. The methods show moderate agreement with each other for lesion size and distance from the anal verge and good agreement for the rectal wall percentage of involvement. Circumferential or almost circumferential lesions have a greater chance of postoperative stenosis. Patients with more advanced lesions on AP who underwent radical resections had lower overall survival.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: August 7, 2023
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria: patients with diagnosis of mid or distal rectum neoplasms stage 1 -

Exclusion Criteria: advanced rectal cancer (stage II, III or IV)

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Related Conditions & MeSH terms

• Neoplasms
• Rectal Cancer
• Rectal Cancer Stage I
• Rectal Neoplasms

Intervention

Procedure:
• three-dimensional endorectal ultrasonography
three-dimensional endorectal ultrasonography

Locations

Country	Name	City	State
Brazil	Medicine School, Sao Paulo University	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Kawaguti FS, Franco MC, Martins BC, Segateli V, Marques CFS, Nahas CSR, Pinto RA, Safatle-Ribeiro AV, Ribeiro-Junior U, Nahas SC, Maluf-Filho F. Role of Magnification Chromoendoscopy in the Management of Colorectal Neoplastic Lesions Suspicious for Submuc — View Citation

Nahas SC, Nahas CSR, Bustamante-Lopez LA, Pinto RA, Marques CFS, Cecconello I. Outcomes of surgical treatment for patients with distal rectal cancer: A retrospective review from a single university hospital. Rev Gastroenterol Mex. 2020 Apr - Jun;85(2):180 — View Citation

Pinto RA, Corrêa Neto IJ, Nahas SC, Rizkalah Nahas CS, Sparapan Marques CF, Ribeiro Junior U, Kawaguti FS, Cecconello I. Efficacy of 3-Dimensional Endorectal Ultrasound for Staging Early Extraperitoneal Rectal Neoplasms. Dis Colon Rectum. 2017 May;60(5):4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of parietal invasion (T),	Patients with Stage T after procedure	immediately after the procedure