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the Optimal Surveillance Frequency for Patients With Gastric Neuroendocrine Carcinoma

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05671393
Enrollment
801
Registered
2023-01-04
Start date
2008-01-01
Completion date
2022-12-15
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Neuroendocrine Carcinoma

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Fujian Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
recurrence rate60 monthsdistant, peritoneal, and local recurrence

Secondary

MeasureTime frameDescription
Delayed-detection months60 monthsA 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.
Incremental cost-effectiveness ratios (ICERs)60 monthsICERs were calculated by dividing the difference in cost by the difference in QALY

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026