Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors

Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors Based on the Pathological Evaluation Following Initial Endoscopic Resection: A Multi-center Study

we evaluated all related clinical and pathologic data of rectal NET cases, including the resection margin status, NET grading, and lymphovascular invasion status. Finally, the present study was aimed at (1) determining the risk factors for LN and distant metastases in colorectal NETs (2) clarifying the clinical significance of the salvage treatment for colorectal neuroendocrine tumors following initial endoscopic resection with positive resection margin status and (3) compare different salvage treatment of this uncommon disease through conducting a large, multi-center cohort study.

Study Overview

• Status: Completed
• Conditions: Rectal Neoplasms; Neuroendocrine Tumors
• Intervention / Treatment: Procedure: salvage treatment

• Study Type: Observational
• Enrollment (Actual): 527

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with rectal neuroendocrine tumors following initial endoscopic resection

Description

Inclusion Criteria:

• within the age range of 18 to 65 years, diagnosed with rectal neuroendocrine tumors. Furthermore, patients were required to have a palpable tumor as determined by digital rectal examination or accessible through proctoscopy, with the distal border situated within 12 cm from the anal verge.

Exclusion Criteria:

• (1) muscularis propria invasion or NET grading = 3, (2)regional LN or distant organs metastasis at the time of diagnosis, (3) incomplete follow-up information, (4) the patient had multiple primary tumors, (5) patients with surgical excision or inappropriate methods such as forceps removal, and (6) the patient had a history of malignant tumors.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
salvage treatment group; patients with salvage treatment after endoscopic resection were diagnosed as having positive resection margin status	Procedure: salvage treatment; salvage radical surgery or endoscopic resection
without salvage treatment group; patients without salvage treatment after endoscopic resection were diagnosed as having positive resection margin status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	disease free survival	5 year

Collaborators and Investigators

• Sponsor: Yanhong Deng

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2013
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Estimated): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: endoscopic resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Neuroendocrine Tumors
• Other Study ID Numbers: GIH-SYip33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No