RecruitingNCT07542171

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

400 participants

Start Date

Sep 3, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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.

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Interventions

PROCEDUREAdditional Surgery

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

OTHERSurveillance

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


Locations(3)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Shenzhen Longgang District People's Hospital

Shenzhen, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Haizhu, Guangzhou, China

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NCT07542171