Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors

NCT06143605 | Completed

• 1 other identifier: GIH-SYip33
• Study Type: observational
• Target: 527
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rectal Neoplasms; Neuroendocrine Tumors

Keywords

endoscopic resection

Outcome Measures

Primary Outcomes (1)

• DFS

  disease free survival

  5 year

Study Arms (2)

salvage treatment group

patients with salvage treatment after endoscopic resection were diagnosed as having positive resection margin status

Procedure: salvage treatment

without salvage treatment group

patients without salvage treatment after endoscopic resection were diagnosed as having positive resection margin status

Interventions

salvage treatment PROCEDURE

salvage radical surgery or endoscopic resection

salvage treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with rectal neuroendocrine tumors following initial endoscopic resection

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Yanhong Deng: lead

MeSH Terms

Conditions

Rectal Neoplasms; Neuroendocrine Tumors

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: January 30, 2013
• Primary Completion: December 30, 2022
• Study Completion: September 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share