Outcomes after non-curative endoscopic removal of early colorectal cancer

Clinical Outcomes After Non-curative Endoscopic Resection in Early Colorectal Cancer: A Multicenter Study

This project will compare additional surgery versus surveillance to see if one approach leads to fewer recurrences and better survival for adults with early colorectal cancer after non-curative endoscopic resection.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 3 sites (Guangzhou, Guangdong and 2 other locations)
• Trial ID: NCT07542171 on ClinicalTrials.gov

What this trial studies

This multicenter observational study will enroll adults who had endoscopic resection for early colorectal cancer but whose pathology indicates a non-curative result, and will follow patients managed with either additional surgery or surveillance according to real-world clinical decisions. Investigators will collect baseline demographic, endoscopic, and pathological data and record treatments and outcomes across participating centers. The primary comparison is recurrence and survival between management strategies, while secondary aims include identifying prognostic factors and building a risk stratification model to guide individualized decisions. Standardized follow-up per clinical guidelines will be used to capture recurrence, complications, and survival outcomes.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed early colorectal cancer who underwent endoscopic resection and meet pathological criteria for non-curative resection with complete clinicopathological and follow-up data are ideal candidates.

Not a fit: Patients with synchronous advanced colorectal cancer or distant metastases, active other malignancies, hereditary colorectal cancer syndromes, inflammatory bowel disease, prior neoadjuvant therapy, or incomplete data are unlikely to benefit from this study's findings.

Why it matters

Potential benefit: If successful, the findings could help doctors choose surgery or surveillance more accurately, reducing unnecessary operations while keeping recurrence risk low.

How similar studies have performed: Retrospective and single-center series have identified risk factors after non-curative endoscopic resection, but prospective multicenter risk models and direct comparisons of surgery versus surveillance remain limited.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years;
* Patients with early colorectal cancer confirmed by histopathology;
* Patients who underwent endoscopic resection (including EMR, ESD, or equivalent techniques);
* Pathological diagnosis indicating non-curative resection, defined by the presence of at least one of the following: positive resection margin, submucosal invasion depth \>1000 μm, poor differentiation, lymphovascular invasion, perineural invasion, or high-grade tumor budding;
* Availability of complete clinicopathological and follow-up data;
* Patients managed with either additional surgery or surveillance after endoscopic resection.

Exclusion Criteria:

* Patients with synchronous advanced colorectal cancer or distant metastasis at baseline;
* History of other active malignancies;
* Patients with inflammatory bowel disease, familial adenomatous polyposis, or other hereditary colorectal cancer syndromes;
* Patients who received neoadjuvant therapy before endoscopic resection;
* Incomplete pathological data or missing key variables;
* Loss to follow-up or follow-up duration less than 6 months.

Where this trial is running

Guangzhou, Guangdong and 2 other locations

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Shenzhen Longgang District People's Hospital — Shenzhen, Guangdong, China (Recruiting)
• The Second Affiliated Hospital of Guangzhou Medical University — Haizhu, Guangzhou, China (Recruiting)

Study contacts

• Study coordinator: Aimin Li

Conditions Early Colorectal Cancer; Non-curative Endoscopic Resection; Early colorectal cancer; Non-curative resection