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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

This multicenter cohort study includes adult patients with early colorectal cancer who underwent non-curative endoscopic resection. Participants are stratified into additional surgery and surveillance groups based on post-resection management strategies. Comprehensive clinicopathological characteristics and follow-up data are collected to evaluate recurrence patterns, survival outcomes, and to develop and validate a risk prediction model.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Additional Surgery

    Procedure/Surgery

    Additional surgical resection performed after non-curative endoscopic resection based on pathological risk factors and clinical indications.

  • Surveillance

    Other intervention

    Active surveillance with regular endoscopic and imaging follow-up without additional surgical intervention.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Additional Surgery1 intervention
Group B: Surveillance1 intervention

Trial outcomes

Primary outcomes

1

Recurrence-Free Survival

Time frame
Up to 2 years

Secondary outcomes

1

Association Between High-Risk Pathological Factors and Recurrence

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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