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Completed

NCT Number: NCT03852693

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

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.

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Key information

Conditions

Neuroendocrine Tumors of the Appendix

Sex eligibility

All sexes

Study type

Observational

Primary location

UHIBerne

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Histopathological review

Other

Histopathological review

Primary outcomes

  1. Clinically relevant relapse of aNET measuring 1 - 2 cm in a population based manner

    Time frame: 10 years

  2. Clinically relevant mortality of aNET measuring 1 - 2 cm in a population based manner

    Time frame: 10 years

  3. Frequency of distant metastases in aNET measuring 1-2 cm

    Time frame: 10 years

Secondary outcomes

  1. 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

    Time frame: 10 years

  2. Relationship between regional lymph node metastasis and survival in patients with aNET measuring 1 - 2 cm

    Time frame: 10 years

  3. Long-term survival after complete resection of aNET measuring 1 - 2 cm with or without oncological right-sided hemicolectomy

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix: An International Multicenter Study

Acronym: SurvivApp

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2019
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.