ESD in Locally Advanced Rectal Cancer Following CRT

Sponsor
Assiut University
Study ID
NCT07192627
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic mucosal dissection — PROCEDURE
    Removal of lesions extending down to submucosa

Study Details

residual mucosal lesions in patients with locally advanced rectal cancer after CRT are still confusing for decision to continue follow up or excise. Investigators decided to compare two groups with cCR or nCR with MDT management decision to whether do ESD for this residual lesion or continue follow up and its effect on disease free survival.

Key Dates

First listed
Sep 25, 2025
Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Residual mucosal lesion amenable for ESD after CRT
    Mucosal lesions following CRT amenable for ESD will be resected with pathological examination
  • Arm: Residual mucosal lesion not amenable for ESD after CRT
    wait and watch strateagy

Primary Outcome Measure

- Compare 1-year disease-free survival (DFS) between patients treated with ESD for small residual rectal lesions after locoregional CRT (CRT→ESD) and patients managed with close surveillance after CRT (CRT→Follow-up). [ Time Frame: one year ]

Central Contacts

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