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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 August 2021 |
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Main ID: |
NCT02385630 |
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Date of registration:
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02/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer
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Scientific title:
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Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02385630 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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John V Reynolds, MCh, FRCS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Surgery, St. James's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients scheduled to undergo two-stage, three-stage or transhiatal oesophagectomy
with gastric conduit reconstruction OR total gastrectomy with Roux-en-Y reconstruction
Exclusion Criteria:
1. Significant and persistent chemoradiotherapy complication
2. Other previous upper gastrointestinal surgery
3. Unwell or unable to eat
4. Other disease or medications which may affect satiety gut hormone responses
5. Active and significant psychiatric illness including substance misuse
6. Cognitive or communication issues or any factors affecting capacity to consent to
participation
7. History of significant food allergy, certain dietary restrictions
8. Confirmed or suspected residual or recurrent disease after surgery, synchronous or
metachronous malignancy
9. Significant surgical complication, aspiration risk or deterioration in performance
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Esophageal Neoplasms
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Weight Loss
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Malnutrition
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Stomach Neoplasms
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Intervention(s)
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Other: Standardized 400kcal semi-liquid meal
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Primary Outcome(s)
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Post-prandial satiety gut hormone area under the curve
[Time Frame: 1 year]
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Secondary Outcome(s)
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EORTC health related quality of life at one year
[Time Frame: 1 year]
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Subjective symptom scores
[Time Frame: 1 year]
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Body anthropometry
[Time Frame: 1 year]
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Fasting ghrelin concentration
[Time Frame: 1 year]
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Secondary ID(s)
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CRFSJ 0058
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2014-12 CA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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