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Trial record 3 of 4 for:    17968169 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02385630
Recruitment Status : Unknown
Verified February 2016 by Dr Jessie A Elliott, St. James's Hospital, Ireland.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2015
Last Update Posted : February 10, 2016
Sponsor:
Collaborators:
University College Dublin
University of Dublin, Trinity College
Information provided by (Responsible Party):
Dr Jessie A Elliott, St. James's Hospital, Ireland

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Stomach Neoplasms Weight Loss Malnutrition Other: Standardized 400kcal semi-liquid meal Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer
Study Start Date : March 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Esophagectomy

Serial assessment:

Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal

Other: Standardized 400kcal semi-liquid meal
Used to assess post-prandial gut hormone response pre-operatively and at 10 days, 4 weeks, 6 months and 12 months post-operatively.

Experimental: Gastrectomy

Serial assessment:

Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal

Other: Standardized 400kcal semi-liquid meal
Used to assess post-prandial gut hormone response pre-operatively and at 10 days, 4 weeks, 6 months and 12 months post-operatively.




Primary Outcome Measures :
  1. Post-prandial satiety gut hormone area under the curve [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Body antropometry [ Time Frame: 1 year ]
    Weight (kg), height, waist circumference, hip circumference

  2. Quality of life [ Time Frame: 1 year ]
    EORTC QLQ-30, OG25, OES 18

  3. Subjective symptom scores [ Time Frame: 1 year ]
    Sigstad dumping score, modified visual analogue scale

  4. Fasting ghrelin concentration [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385630


Locations
Ireland
Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Dublin, Ireland, D8
Sponsors and Collaborators
St. James's Hospital, Ireland
University College Dublin
University of Dublin, Trinity College
Investigators
Principal Investigator: John V Reynolds, MCh, FRCS Department of Surgery, St. James's Hospital

Additional Information:
Publications:

Responsible Party: Dr Jessie A Elliott, Surgical Research Fellow, St. James's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT02385630     History of Changes
Other Study ID Numbers: CRFSJ 0058
2014-12 CA ( Other Identifier: St. James's Hospital Research Ethics Committee )
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016

Keywords provided by Dr Jessie A Elliott, St. James's Hospital, Ireland:
Longitudinal Studies
Esophagectomy
Gastrectomy
Hunger
Appetite
Glucagon-like Peptide 1
Peptide YY
Ghrelin
Satiety Response
Feeding Behavior
Meals
Postprandial Period

Additional relevant MeSH terms:
Neoplasms
Weight Loss
Malnutrition
Stomach Neoplasms
Esophageal Neoplasms
Body Weight Changes
Body Weight
Signs and Symptoms
Nutrition Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs