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Trial record 3 of 5 for:    Leonardo Alfonso Bustamante

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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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

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




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



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)

-


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
Publications of Results:
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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