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

U

University of Sao Paulo

Status

Unknown

Conditions

Rectal Cancer Stage I
Rectal Cancer

Treatments

Procedure: three-dimensional endorectal ultrasonography

Study type

Interventional

Funder types

Other

Identifiers

NCT04527939
9076079

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

three-dimensional endorectal ultrasonography
Active Comparator group
Description:
three-dimensional endorectal ultrasonography
Treatment:
Procedure: three-dimensional endorectal ultrasonography
magnification chromoendoscopy.
Sham Comparator group
Description:
magnification chromoendoscopy.
Treatment:
Procedure: three-dimensional endorectal ultrasonography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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