Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03377660
Eligibility Criteria:
Inclusion Criteria:
1. History of esophagectomy with gastric conduit reconstruction
2. Recurrence-free at least 12 months post-operatively
3. Weight loss ≥10% from premorbid weight, or requiring ongoing caloric supplementation
4. Due to undergo clinical treatment for weight loss with Sandostatin or Mirtazapine
Exclusion Criteria:
1. Pregnancy, breastfeeding
2. Significant and persistent chemoradiotherapy and/or surgical complication
3. Other active malignancy
4. Exocrine pancreatic insufficiency detected using fecal elastase
5. Uncontrolled diabetes mellitus
6. Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent
7. Severe dysphagia
8. Other disease or medication which may impact gut hormone physiology
9. History of significant food allergy, certain dietary restrictions
10. Any definite contraindication to somatostatin analogue administration
11. Claustrophobia, or any absolute contraindication to MRI scanning
12. Metallic implants, precluding fMRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03377660
Study Brief:
Protocol Section:
NCT03377660