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

Primary Purpose

Esophageal Neoplasms, Stomach Neoplasms, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Standardized 400kcal semi-liquid meal
Sponsored by
St. James's Hospital, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Esophageal Neoplasms focused on measuring Longitudinal Studies, Esophagectomy, Gastrectomy, Hunger, Appetite, Glucagon-like Peptide 1, Peptide YY, Ghrelin, Satiety Response, Feeding Behavior, Meals, Postprandial Period

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Esophagectomy

Gastrectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Post-prandial satiety gut hormone area under the curve

Secondary Outcome Measures

Body anthropometry
Weight (kg)
EORTC health related quality of life at one year
Global health status score
Subjective symptom scores
Sigstad dumping score
Fasting ghrelin concentration

Full Information

First Posted
March 2, 2015
Last Updated
August 12, 2021
Sponsor
St. James's Hospital, Ireland
Collaborators
University College Dublin, University of Dublin, Trinity College
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1. Study Identification

Unique Protocol Identification Number
NCT02385630
Brief Title
Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer
Official Title
Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. James's Hospital, Ireland
Collaborators
University College Dublin, University of Dublin, Trinity College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Stomach Neoplasms, Weight Loss, Malnutrition
Keywords
Longitudinal Studies, Esophagectomy, Gastrectomy, Hunger, Appetite, Glucagon-like Peptide 1, Peptide YY, Ghrelin, Satiety Response, Feeding Behavior, Meals, Postprandial Period

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esophagectomy
Arm Type
Experimental
Arm Description
Serial assessment: Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal
Arm Title
Gastrectomy
Arm Type
Experimental
Arm Description
Serial assessment: Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal
Intervention Type
Other
Intervention Name(s)
Standardized 400kcal semi-liquid meal
Intervention Description
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 Measure Information:
Title
Post-prandial satiety gut hormone area under the curve
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Body anthropometry
Description
Weight (kg)
Time Frame
1 year
Title
EORTC health related quality of life at one year
Description
Global health status score
Time Frame
1 year
Title
Subjective symptom scores
Description
Sigstad dumping score
Time Frame
1 year
Title
Fasting ghrelin concentration
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John V Reynolds, MCh, FRCS
Organizational Affiliation
Department of Surgery, St. James's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
City
Dublin
ZIP/Postal Code
D8
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17668914
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
result
Links:
URL
http://www.sjhcrf.ie
Description
Wellcome Trust-HRB Clinical Research Facility
URL
http://www.ucd.ie/conway/
Description
Conway Institute of Biomolecular and Biomedical Research
URL
https://medicine.tcd.ie/surgery/
Description
Department of Surgery, Trinity College Dublin and St. James's Hospital

Learn more about this trial

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

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