ESD in Locally Advanced Rectal Cancer Following CRT

September 23, 2025 updated by: Yusuf Salah-eldin Amry Ahmad, Assiut University

Selective Endoscopic Resection vs. Surveillance Following CRT for Rectal Cancer: 1-Year Oncologic and Functional Outcomes

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Asyut, Egypt, 71515
        • Assiut University
        • Contact:
          • Vice president of graduate studies of Assiut university
          • Phone Number: 00208822080150
          • Email: vp_grad@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who completed locoregional chemoradiotherapy with organ preservation intent will be prospectively enrolled. Post-CRT restaging at 8-12 weeks will be discussed at MDT. Patients with a small residual mucosal/submucosal lesion amenable to en-bloc endoscopic resection will be offered ESD (CRT→ESD). Patients with clinical/radiologic complete or near-complete response and no endoscopically resectable residual lesion will be managed with structured surveillance (CRT→Follow-up)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Residual mucosal lesion amenable for ESD after CRT
Mucosal lesions following CRT amenable for ESD will be resected with pathological examination
Procedure: Endoscopic mucosal dissection
Removal of lesions extending down to submucosa
Residual mucosal lesion not amenable for ESD after CRT
wait and watch strateagy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Compare local regrowth/recurrence rates at 1 year between the two groups. - Compare organ-preservation rate at 1 year (proportion avoiding TME).
Time Frame: One year
- Compare local regrowth/recurrence rates at 1 year between the two groups.
One year
Compare organ-preservation rate at 1 year (proportion avoiding TME).
Time Frame: One year
The need for surgery in either group
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

September 11, 2025

First Submitted That Met QC Criteria

September 23, 2025

First Posted (Estimated)

September 25, 2025

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESD in rectal cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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