Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors

Sponsor

Yanhong Deng (Other)

Overall Status

Completed

CT.gov ID

NCT06143605

Collaborator

(none)

527

Enrollment

128

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Neoplasms Neuroendocrine Tumors	Procedure: salvage treatment

Study Design

Study Type:

Observational

Actual Enrollment :

527 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 30, 2013

Actual Primary Completion Date :

Dec 30, 2022

Actual Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

DFS [5 year]
disease free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Yanhong Deng

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanhong Deng, M.D., Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT06143605

Other Study ID Numbers:

GIH-SYip33

First Posted:

Nov 22, 2023

Last Update Posted:

Nov 22, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yanhong Deng, M.D., Sun Yat-sen University

endoscopic resection

Additional relevant MeSH terms:

Neuroendocrine Tumors

Rectal Neoplasms

Study Results

No Results Posted as of Nov 22, 2023