Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix

Completed

• Conditions: Neuroendocrine Tumors of the Appendix
• Interventions: Other: Histopathological review

• Registration Number: NCT03852693
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

The aim of the present project is to evaluate the frequency of distant metastases and clinically relevant relapse and mortality, respectively, of aNEN (Neuroendocrine Neoplasms of the Appendix) measuring 1 - 2 cm.

The investigators hypothesize that the mortality rate of aNET (Neuroendocrine Tumors of the Appendix) measuring 1 - 2cm is less than 1%. Furthermore, the investigators hypothesize that regional lymph node metastases of aNET measuring 1 - 2 cm are clinically not relevant and are not associated with reduced survival. The investigators therefore hypothesize that oncological right-sided hemicolectomy has no impact on long-term survival after complete resection of aNET measuring 1 - 2 cm and that the malignant potential quo ad vitam of these tumors is lower than the risk of oncological hemicolectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-25
• Study Start: 2020-10-01
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

• The investigators will include all patients with aNET measuring 1 - 2 cm and complete resection between 01.01.2005 and 31.12.2010 of the primary tumor.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Group	Histopathological review	-
Prospective Group	Histopathological review	-

Primary Outcome Measures

Name	Time	Method
Clinically relevant relapse of aNET measuring 1 - 2 cm in a population based manner	10 years
Clinically relevant mortality of aNET measuring 1 - 2 cm in a population based manner	10 years
Frequency of distant metastases in aNET measuring 1-2 cm	10 years

Secondary Outcome Measures

Name	Time	Method
Association of histological risk factors in aNET measuring 1 - 2 cm and qualifying for oncological right-sided hemicolectomy according to ENETS guidelines with the occurrence of regional lymph node and distant metastases	10 years
Relationship between regional lymph node metastasis and survival in patients with aNET measuring 1 - 2 cm	10 years
Long-term survival after complete resection of aNET measuring 1 - 2 cm with or without oncological right-sided hemicolectomy	10 years

Trial Locations

Locations (1)

UHIBerne; 🇨🇭 Bern, Switzerland