CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Standardized 400kcal semi-liquid mealother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02385630
NCT02385630N/ACompleted

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

St. James's Hospital, Ireland·interventional·Posted Mar 11, 2015·Updated Aug 18, 2021

In Brief

A clinical study evaluating Standardized 400kcal semi-liquid meal for Esophageal Neoplasms and 3 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 11, 2015
Enrollment StartMar 1, 2015
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.3 years ago

Interventions

Standardized 400kcal semi-liquid mealother

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