Clinical Outcomes After Non-curative Endoscopic Resection in Early Colorectal Cancer: A Multicenter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additional Surgery, Surveillance.
- Who it may be relevant to
- Registry conditions: Early Colorectal Cancer, Non-curative Endoscopic Resection. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This multicenter study aims to evaluate clinical outcomes and optimize management strategies in patients with early colorectal cancer who undergo non-curative endoscopic resection. Patients with non-curative resection following endoscopic treatment will be enrolled across multiple centers and managed according to real-world clinical decisions, including additional surgery or surveillance. Baseline demographic, endoscopic, and pathological characteristics will be systematically collected. The primary objective is to compare recurrence and survival outcomes between different management strategies. Secondary objectives include identifying prognostic factors associated with recurrence and developing a risk stratification model to guide individualized treatment decisions. All participants will undergo standardized follow-up according to clinical guidelines. This study is expected to provide real-world evidence to refine risk assessment, reduce unnecessary surgery, and improve personalized management for patients with early colorectal cancer after non-curative endoscopic resection.
Interventions
- Procedure Additional Surgery
Additional surgical resection performed after non-curative endoscopic resection based on pathological risk factors and clinical indications. - Other Surveillance
Active surveillance with regular endoscopic and imaging follow-up without additional surgical intervention.
Primary outcome measures
- Recurrence-Free Survival [Time frame: Up to 2 years]
Secondary outcome measures (1)
- Association Between High-Risk Pathological Factors and Recurrence [Time frame: Up to 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 3 centers
- Nanfang Hospital, Southern Medical University — Guangzhou
- Shenzhen Longgang District People's Hospital — Shenzhen
- The Second Affiliated Hospital of Guangzhou Medical University — Haizhu
Identifiers
NCT: NCT07542171 · NFEC-2025-405