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

NCT07542171 | Recruiting

• 1 other identifier: NFEC-2025-405
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Early Colorectal Cancer; Non-curative Endoscopic Resection

Keywords

Early colorectal cancer; Non-curative resection

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival

  Up to 2 years

Secondary Outcomes (1)

• Association Between High-Risk Pathological Factors and Recurrence

  Up to 2 years

Study Arms (2)

Additional Surgery

Patients who underwent additional surgical resection following non-curative endoscopic resection based on pathological risk factors and clinical decision-making.

Procedure: Additional Surgery

Surveillance

Patients managed with surveillance after non-curative endoscopic resection, including regular endoscopic and imaging follow-up without additional surgical intervention.

Other: Surveillance

Interventions

Additional Surgery PROCEDURE

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

Additional Surgery

Surveillance OTHER

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

Surveillance

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (3)

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, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Aimin Li

CONTACT

86-13580317630; lam0725@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: September 3, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)