the Optimal Surveillance Frequency for Patients With Gastric Neuroendocrine Carcinoma

Sponsor
Fujian Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05671393
Collaborator
(none)
801
1
179.4
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    801 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Multi-institution Real-world Study of the Optimal Surveillance Frequency for Patients With Gastric Neuroendocrine Carcinoma
    Actual Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 15, 2022

    Outcome Measures

    Primary Outcome Measures

    1. recurrence rate [60 months]

      distant, peritoneal, and local recurrence

    Secondary Outcome Measures

    1. Delayed-detection months [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) [60 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chang-ming Huang Fuzhou Fujian China 350001

    Sponsors and Collaborators

    • Fujian Medical University

    Investigators

    • Principal Investigator: Chang-ming Huang, MD, Fujian Medical University Union Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang-Ming Huang, Prof., Director of gastric surgery, Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT05671393
    Other Study ID Numbers:
    • FUNEC-01
    First Posted:
    Jan 4, 2023
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2023