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Completed

NCT Number: NCT05671393

the Optimal Surveillance Frequency for Patients With Gastric Neuroendocrine Carcinoma

Due to lacking of evidence on surveillance for gastric neuroendocrine carcinoma (G-NEC), this study aimed to determine the optimal postsurgical surveillance strategy for G-NEC patients and compare its cost-effectiveness with traditional surveillance strategies.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang-ming Huang

Fuzhou, Fujian, 350001, China

About this study

The development of existing follow-up strategies is mainly based on experts' consensus and researches on recurrence patterns due to the lack of direct evidence and unified standards. On the one hand, it is unreasonable to carry out the same postoperative surveillance for all G-NEC patients. In addition to the early detection of recurrence, the optimal follow-up strategy should also balance cost and effectiveness. There were no criteria for the arrangement of follow-up in different guidelines, and the optimal postoperative follow-up strategy for patients with G-NEC remains unclear. Patients with G-NEC from 21 centers in China were included. Cost-effectiveness were assessed by Markov model.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

This multicentre retrospective study included patients with gastric neuroendocrine neoplasms who underwent surgery in 21 centres of the Study Group for Gastric Neuroendocrine Tumours in China from January 2008 to December 2016. Radical surgery included a D2 lymphadenectomy consistent with the Japanese gastric cancer treatment guidelines.

Exclusion criteria

Patients with tumours of unknown pathology (only neuroendocrine neoplasms recorded without detailed information); patients with gastric NETs; patients who had endoscopic submucosal dissection or endoscopic mucosal resection; patients who received neoadjuvant chemotherapy; patients who died within 3 months of surgery from postoperative complications; and patients with unknown tumour size or who were lost to follow-up

Treatment and study plan

Primary outcomes

  1. recurrence rate

    Time frame: 60 months

    distant, peritoneal, and local recurrence

Secondary outcomes

  1. Delayed-detection months

    Time frame: 60 months

    A hypothetical cohort of 1000 G-NEC patients was generated to compare the effectiveness of surveillance among the above-mentioned strategies by calculating the sum of the delayed detection months. Delayed detection months were defined as the duration from the occurrence of failure to the next-nearest follow-up. For instance, if a patient develops distant metastasis in the 3rd month while the next nearest planned visit is in the 5th month, the delayed -detection time for this patient is 2 months. The total number of delayed detection months of our risk-based surveillance schedule and that of the control strategies were simulated and compared.

  2. Incremental cost-effectiveness ratios (ICERs)

    Time frame: 60 months

    ICERs were calculated by dividing the difference in cost by the difference in QALY

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

A Multi-institution Real-world Study of the Optimal Surveillance Frequency for Patients With Gastric Neuroendocrine Carcinoma

Important dates

Study start
2008
Primary completion
2016
Study completion
2022
First posted
Jan 4, 2023
Registry last updated
Jan 4, 2023

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.

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