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Clinical Trials in Egypt / NCT07192627
Starting soon Observational

ESD in Locally Advanced Rectal Cancer Following CRT

NCT07192627 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Observational
Started
2025-10-01
Last updated
2025-09-25

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Endoscopic mucosal dissection

Endoscopic mucosal dissection: Removal of lesions extending down to submucosa

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients with rectal adenocarcinoma who underwent full course locoregional chemoradiotherapy with organ-preservation intent. Post-CRT assessment showing either: A. Small residual mucosal/submucosal lesion amenable to en-bloc ESD (CRT→ESD), OR B. Clinical/radiologic near-complete/complete response and decision to observe (CRT→Follow-up). Exclusion Criteria: * \- Evidence of distant metastasis at post-CRT restaging. * Lesions unsuitable for endoscopic resection (circumferential, deeply invasive on EUS/MRI). * Patients who had immediate TME after CRT for other reasons. * Unfit for endoscopy or follow-up.

Primary outcome measure(s)

  • - 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). — one year
    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)

Trial sites (1)

FacilityCityRegionStatus
Assiut University Asyut Egypt

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07192627 on ClinicalTrials.gov ↗ ← All trials in Egypt