Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer

Study Overview
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Brief Summary
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Surgery is the cornerstone of treatment for patients with oesophageal or gastric cancer, but while surgical removal of the tumour (oesophagectomy or gastrectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are relatively common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited. The investigators research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone upper gastrointestinal surgery. These chemical messengers play a role in signalling the feeling of fullness during and after a meal (satiety). Understanding the mechanisms involved in increased gut hormone secretion after these operations may allow us to use certain medications to block gut hormone release and hence reduce satiety allowing patients to eat more, regain weight and prevent nutritional complications after surgery. Exaggerated post-prandial satiety gut hormone responses following oesophagectomy have, however, only been established cross-sectionally and therefore the time course for development of increased gut hormone secretion is unknown. Data collected from this study will provide important information about optimal timing of therapeutic intervention in this patient group, while offering mechanistic insights with regard to the pathophysiologic process underlying post-operative early satiety.

Official Title
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Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer

Conditions
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Esophageal Neoplasms, Stomach Neoplasms, Weight Loss, Malnutrition

Intervention / Treatment
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* Other: Standardized 400kcal semi-liquid meal


Participation Criteria
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Eligibility 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: Significant and persistent chemoradiotherapy complication Other previous upper gastrointestinal surgery Unwell or unable to eat Other disease or medications which may affect satiety gut hormone responses Active and significant psychiatric illness including substance misuse Cognitive or communication issues or any factors affecting capacity to consent to participation History of significant food allergy, certain dietary restrictions Confirmed or suspected residual or recurrent disease after surgery, synchronous or metachronous malignancy Significant surgical complication, aspiration risk or deterioration in performance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esophagectomy<br>Serial assessment: Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal | Other: Standardized 400kcal semi-liquid meal<br>* Used to assess post-prandial gut hormone response pre-operatively and at 10 days, 4 weeks, 6 months and 12 months post-operatively.<br>|
| Experimental: Gastrectomy<br>Serial assessment: Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal | Other: Standardized 400kcal semi-liquid meal<br>* Used to assess post-prandial gut hormone response pre-operatively and at 10 days, 4 weeks, 6 months and 12 months post-operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial satiety gut hormone area under the curve |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body anthropometry | Weight (kg) | 1 year | 
| EORTC health related quality of life at one year | Global health status score | 1 year | 
| Subjective symptom scores | Sigstad dumping score | 1 year | 
| Fasting ghrelin concentration |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Longitudinal Studies, Esophagectomy, Gastrectomy, Hunger, Appetite, Glucagon-like Peptide 1, Peptide YY, Ghrelin, Satiety Response, Feeding Behavior, Meals, Postprandial Period