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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04527939
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.9

Study Details

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	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Extraperitoneal rectal cancer stage 1Extraperitoneal 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: Aug 7, 2020
• Actual Primary Completion Date: Aug 10, 2020
• Anticipated Study Completion Date: Aug 7, 2023

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

1. Degree of parietal invasion (T), [immediately after the procedure]

   Patients with Stage T after procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Medicine School, Sao Paulo University	Sao Paulo		Brazil	05403-900

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leonardo Alfonso Bustamante, Principal Investigator, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT04527939
• Other Study ID Numbers: 9076079
• First Posted: Aug 27, 2020
• Last Update Posted: Aug 27, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Rectal Neoplasms

Study Results

No Results Posted as of Aug 27, 2020