Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.

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Detailed Description

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Conditions

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Gastric NET

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Octreotide

Patients will receive 6-12 monthly injections every 28 (+/- 3) days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologic diagnosis of gastric neuroendocrine tumor.
* Clinical diagnosis of Type I gastric NET: neuroendocrine tumor arising from atrophic body gastritis (ABG diagnosis should be based on hypergastrinemia and histological confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum and body).
* Previous esophagogastroduodenoscopy: all visible NETs resected with R0 margin, confirmed no visible gastric NETs left, multiple biopsies taken to evaluate gastric atrophy and ECL status.
* No tumor metastases confirmed by endoscopic ultrasonography, CT scan or somatostatin receptor scintigraphy.
* SSA therapy is recommended by physician for disease management, and has not yet begun.
* Written informed consent obtained prior to treatment to be consistent with local regulatory requirements.

Exclusion Criteria

* Pathological grading as G3 NET (Ki-67\>20%).
* Patients with a known hypersensitivity to somatostatin analogs.
* Known gallbladder or bile duct disease, acute or chronic pancreatitis.
* Known medical condition related with prolonged QT interval.
* Pregnant or lactating women.
* Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
* Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial.
* Patients with a history of non-compliance to medical regimens.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No