Back to resultsAnalysis of Extraperitoneal Rectal Neoplasms Between 3D Endorectal Ultrasonography and Magnification Chromoendoscopy
Primary Purpose
Rectal Cancer, Rectal Cancer Stage I
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
three-dimensional endorectal ultrasonography
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria: patients with diagnosis of mid or distal rectum neoplasms stage 1 -
Exclusion Criteria: advanced rectal cancer (stage II, III or IV)
-
Sites / Locations
- Medicine School, Sao Paulo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
three-dimensional endorectal ultrasonography
magnification chromoendoscopy.
Arm Description
three-dimensional endorectal ultrasonography
magnification chromoendoscopy.
Outcomes
Primary Outcome Measures
Degree of parietal invasion (T),
Patients with Stage T after procedure
Secondary Outcome Measures
Full Information
NCT ID
NCT04527939
First Posted
August 19, 2020
Last Updated
August 21, 2020
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04527939
Brief Title
Analysis of Extraperitoneal Rectal Neoplasms Between 3D Endorectal Ultrasonography and Magnification Chromoendoscopy
Official Title
Results of the Comparative Analysis of Invasion Depth of Extraperitoneal Rectal Neoplasms Between Three-dimensional Endorectal Ultrasonography and Magnification Chromoendoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
August 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Rectal Cancer Stage I
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Extraperitoneal rectal cancer stage 1
Masking
Investigator
Masking Description
Only investigator
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
three-dimensional endorectal ultrasonography
Arm Type
Active Comparator
Arm Description
three-dimensional endorectal ultrasonography
Arm Title
magnification chromoendoscopy.
Arm Type
Sham Comparator
Arm Description
magnification chromoendoscopy.
Intervention Type
Procedure
Intervention Name(s)
three-dimensional endorectal ultrasonography
Intervention Description
three-dimensional endorectal ultrasonography
Primary Outcome Measure Information:
Title
Degree of parietal invasion (T),
Description
Patients with Stage T after procedure
Time Frame
immediately after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with diagnosis of mid or distal rectum neoplasms stage 1 -
Exclusion Criteria: advanced rectal cancer (stage II, III or IV)
-
Facility Information:
Facility Name
Medicine School, Sao Paulo University
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
comparative analysis of invasion depth of extraperitoneal rectal neoplasms between three-dimensional endorectal ultrasonography and magnification chromoendoscopy.
Citations:
PubMed Identifier
32057523
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 (Engl Ed). 2020 Apr-Jun;85(2):180-189. doi: 10.1016/j.rgmx.2019.05.009. Epub 2020 Feb 11. English, Spanish.
Results Reference
result
PubMed Identifier
30730457
Citation
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.
Results Reference
result
PubMed Identifier
28383448
Citation
Pinto RA, Correa 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.
Results Reference
result
Learn more about this trial
Analysis of Extraperitoneal Rectal Neoplasms Between 3D Endorectal Ultrasonography and Magnification Chromoendoscopy
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