Skip to main content
OpenTrials
Completed

NCT Number: NCT02385630

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized 400kcal semi-liquid meal

Other

Used to assess post-prandial gut hormone response pre-operatively and at 10 days, 4 weeks, 6 months and 12 months post-operatively.

Primary outcomes

  1. Post-prandial satiety gut hormone area under the curve

    Time frame: 1 year

Secondary outcomes

  1. Body anthropometry

    Time frame: 1 year

    Weight (kg)

  2. EORTC health related quality of life at one year

    Time frame: 1 year

    Global health status score

  3. Subjective symptom scores

    Time frame: 1 year

    Sigstad dumping score

  4. Fasting ghrelin concentration

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

St. James's Hospital, Ireland

Other

Collaborators

  • University College Dublin
  • University of Dublin, Trinity College

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 11, 2015
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.