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

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ClinicalTrials.gov Identifier: NCT04527939

Recruitment Status : Active, not recruiting

First Posted : August 27, 2020

Last Update Posted : August 27, 2020

Sponsor:

Information provided by (Responsible Party):

Leonardo Alfonso Bustamante, University of Sao Paulo

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Rectal Cancer Rectal Cancer Stage I	Procedure: three-dimensional endorectal ultrasonography	Not Applicable

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	70 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Extraperitoneal rectal cancer stage 1
Masking:	Single (Investigator)
Masking Description:	Only investigator
Primary Purpose:	Treatment
Official Title:	Results of the Comparative Analysis of Invasion Depth of Extraperitoneal Rectal Neoplasms Between Three-dimensional Endorectal Ultrasonography and Magnification Chromoendoscopy
Actual Study Start Date :	August 7, 2020
Actual Primary Completion Date :	August 10, 2020
Estimated Study Completion Date :	August 7, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: three-dimensional endorectal ultrasonography three-dimensional endorectal ultrasonography	Procedure: three-dimensional endorectal ultrasonography three-dimensional endorectal ultrasonography
Sham Comparator: magnification chromoendoscopy. magnification chromoendoscopy.	Procedure: three-dimensional endorectal ultrasonography three-dimensional endorectal ultrasonography

Outcome Measures

Primary Outcome Measures :

Degree of parietal invasion (T), [ Time Frame: immediately after the procedure ]
Patients with Stage T after procedure

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527939

Locations

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Brazil
Medicine School, Sao Paulo University
Sao Paulo, Brazil, 05403-900

Sponsors and Collaborators

University of Sao Paulo

More Information

Publications of Results:

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):180-189. doi: 10.1016/j.rgmx.2019.05.009. Epub 2020 Feb 11. English, Spanish.

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 Submucosal Invasion. Dis Colon Rectum. 2019 Apr;62(4):422-428. doi: 10.1097/DCR.0000000000001343.

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):488-496. doi: 10.1097/DCR.0000000000000781.

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Responsible Party:	Leonardo Alfonso Bustamante, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT04527939
Other Study ID Numbers:	9076079
First Posted:	August 27, 2020 Key Record Dates
Last Update Posted:	August 27, 2020
Last Verified:	August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	comparative analysis of invasion depth of extraperitoneal rectal neoplasms between three-dimensional endorectal ultrasonography and magnification chromoendoscopy.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms	Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

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