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

NCT ID: NCT04527939

Last Updated: 2020-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-07

Study Completion Date

2023-08-07

Brief Summary

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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

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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.

Conditions

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Rectal Cancer Rectal Cancer Stage I

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Extraperitoneal rectal cancer stage 1
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Only investigator

Study Groups

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three-dimensional endorectal ultrasonography

three-dimensional endorectal ultrasonography

Group Type ACTIVE_COMPARATOR

three-dimensional endorectal ultrasonography

Intervention Type PROCEDURE

three-dimensional endorectal ultrasonography

magnification chromoendoscopy.

magnification chromoendoscopy.

Group Type SHAM_COMPARATOR

three-dimensional endorectal ultrasonography

Intervention Type PROCEDURE

three-dimensional endorectal ultrasonography

Interventions

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three-dimensional endorectal ultrasonography

three-dimensional endorectal ultrasonography

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Leonardo Alfonso Bustamante

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medicine School, Sao Paulo University

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 32057523 (View on PubMed)

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.

Reference Type RESULT
PMID: 30730457 (View on PubMed)

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.

Reference Type RESULT
PMID: 28383448 (View on PubMed)

Other Identifiers

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9076079

Identifier Type: -

Identifier Source: org_study_id

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