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Status unknownNCT04527939Updated Aug 27, 2020

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

An interventional study of three-dimensional endorectal ultrasonography in Rectal Cancer and Rectal Cancer Stage I, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-27.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Rectal Cancer
  • Rectal Cancer Stage I
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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)

-

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    three-dimensional endorectal ultrasonography

    three-dimensional endorectal ultrasonography

    Procedure: three-dimensional endorectal ultrasonography

  • Sham comparator
    magnification chromoendoscopy.

    magnification chromoendoscopy.

    Procedure: three-dimensional endorectal ultrasonography

Interventions

  • Procedurethree-dimensional endorectal ultrasonography

    three-dimensional endorectal ultrasonography

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What researchers measure

Primary outcomes

  1. Degree of parietal invasion (T),

    Patients with Stage T after procedure

    Time frame: immediately after the procedure

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Study locations

1 site
  • Medicine School, Sao Paulo University
    Sao Paulo, 05403-900, Brazil
08

References and documents

Publications

  • 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. PubMed 32057523 ↗
  • 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. PubMed 30730457 ↗
  • 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. PubMed 28383448 ↗

Individual participant data

Plan to share: No — comparative analysis of invasion depth of extraperitoneal rectal neoplasms between three-dimensional endorectal ultrasonography and magnification chromoendoscopy.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04527939
Lead sponsor
University of Sao Paulo
Responsible party
Leonardo Alfonso Bustamante (Principal Investigator, University of Sao Paulo) — Principal investigator
First posted
Aug 27, 2020
Start date
Aug 7, 2020
Primary completion
Aug 10, 2020
Completion
Aug 7, 2023 (estimated)
Last update
Aug 27, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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