Assiut University
Asyut, 71515, Egypt
NCT Number: NCT07192627
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Asyut, 71515, Egypt
Colorectal cancer (CRC) represents a significant health challenge in Egypt. According to GLOBOCAN 2020, rectal cancer ranks sixth in all cancers among males and females, with 5,231 new cases, accounting for 3.9% of all cancers. El-Moselhy et al., 2025 reported that the rectum was involved in up to 20% of CRC cases in Egypt .
In recent years, there was a shift in management of locally advanced rectal cancer (LARC) toward organ preserving strategies. After neoadjuvant chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT), a notable proportion of patients achieve a clinical complete response (cCR) or near-complete response (nCR) making them candidates for either structured watch-and-wait (W&W) surveillance or selective local interventions designed to avoid total mesorectal excision (TME) .
In phase II OPRA trial, long-term organ preservation was achieved in approximately 50% of participants, with most tumor regrowth occurring within the first two years.
Despite that, small residual mucosal/submucosal lesions with cCR post CRT are still challenging in management with either W&W or ESD. Endoscopic submucosal dissection (ESD) offers en-bloc resection, comprehensive histopathologic evaluation (depth of invasion, lymphovascular invasion, budding, margins), and the option of salvage surgery if needed. Early evidence supports its feasibility and safety in this setting .
One meta-analysis confirms strong effectiveness and low rate of recurrence when ESD is used for residual or recurrent lesions with prior surgery or endoscopy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Removal of lesions extending down to submucosa
Time frame: 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)
Time frame: One year
Time frame: One year
The need for surgery in either group
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Selective Endoscopic Resection vs. Surveillance Following CRT for Rectal Cancer: 1-Year Oncologic and Functional Outcomes
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