An observational study in Esophageal Cancer, Nutrition Disorders and Appetite Disorders, sponsored by St. James's Hospital, Ireland. Completed at 2 sites in Ireland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-16.
Sponsored by St. James's Hospital, Ireland · Observational
The incidence of oesophagogastric cancer has increased by 400% since the 1970s in Ireland and the United Kingdom. In addition, refinement of perioperative management and the now widespread use of multimodal protocols for patients with locally advanced disease have significantly improved outcomes for patients with oesophagogastric cancer treatable with curative intent. Despite significant advances in chemoradiotherapy, surgical resection remains the primary curative option.
Unintentional weight loss and nutritional complications represent serious concerns for patients after radical resection, even among those who remain free from recurrent disease in the long-term. A study from the Swedish Esophageal and Cardia Cancer Registry reported a mean three year weight loss of 10.8% among disease-free patients, with 33.8% of this cohort demonstrating malnutrition at three years post-oesophagectomy.
Mechanisms contributing to weight loss for disease-free patients after upper gastrointestinal surgery are poorly understood, however an association between increasing magnitude of weight loss and the presence of increased satiety is described. Our recent studies at SJH have demonstrated four fold elevated postprandial satiety gut hormone concentrations after oesophagectomy, compared with baseline preoperative values. Postprandial gut hormone levels correlate significantly with postprandial symptoms and altered appetite at 3 months postoperatively, and with body weight loss at 2 years postoperatively. However, the mechanism leading to exaggerated postprandial gut hormone production after upper gastrointestinal surgery is poorly understood, limiting targeted therapeutic options.
In this study, we aim to characterise the role of altered nutrient transit and enteroendocrine cell function in the pathophysiology of excessive post-prandial gut hormone responses after upper gastrointestinal surgery. To do this, we will measure the gut hormone response to a standardised 400 kcal meal, as per previous studies, while concurrently assessing gastrointestinal transit time, and enteroendocrine cell morphology and function. In this way, we will determine whether the magnitude of the postprandial gut hormone response correlates with the rate of nutrient transit into the enteroendocrine L-cell rich small intestine, and whether enteroendocrine cell adaptation occurs after oesophagectomy.
Furthermore, we have previously observed that gut hormone suppression using octreotide is associated with increased ad libitum among subjects after upper gastrointestinal cancer surgery (Elliott JA et al, Annals of Surgery, 2015). The mechanism of action of octreotide may relate to SSTR-5-mediated negative feedback to the enteroendocrine L-cell, but this medication may additionally reduce enteroendocrine L-cell responses through its inhibitory effect on gastrointestinal motility - reducing the rapidity with which nutrients are delivered to the small intestine - and small intestinal nutrient sensing via inhibition of the Na+-dependent glucose transporter SGLT-18-10. Through conduction of this double-blind, randomised, placebo-controlled crossover study, we aim to establish the mechanism of action of octreotide-mediated increased food intake in patients after gastrointestinal surgery. This may inform the design of future targeted interventions for this patient group.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's enrollment of 40 is below the median of 200 across 432 observational studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →St. James's Hospital, Ireland is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients at least 9 months post upper gastrointestinal surgery and age-, weight- and sex-matched control subjects with gastroesophageal reflux disease or non-dysplastic Barrett's oeosophagus.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient group:
Control group:
Exclusion Criteria:
Patients with to the study medications (as per www.medicines.ie) will not be automatically excluded, but will be invited to participate in an attenuated protocol where that agent is not given. It is not anticipated that this will be a frequent occurrence, however this strategy will minimise unnecessary participant exclusion.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Octreotide Acetate · Drug: Saline Solution · Drug: Paracetamol · Drug: Sulfasalazine
Drug: Octreotide Acetate · Drug: Saline Solution · Drug: Paracetamol · Drug: Sulfasalazine
Diagnostic Test: Duodenal biopsy
Diagnostic Test: Duodenal biopsy
50mcg octreotide acetate by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge
Equivalent volume of 0.9% saline by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge
Paracetamol 1g by mouth consumed with a 400kcal mixed meal challenge
1g sulfasalazine by mouth consumed with a 400kcal mixed meal challenge
Biopsy from the second part of the duodenum taken at routine endoscopic surveillance, undertaken for another clinical indication.
Area under the curve for paracetamol at 30 minutes after a 400kcal mixed meal stimulus
Time frame: 30 minutes post meal
Peak paracetamol level
Time frame: Within 300 minutes post meal
GLP-1 area under the curve over 300 minutes after a 400kcal mixed meal stimulus
Time frame: Within 300 minutes post meal
Glucose area under the curve over 300 minutes after a 400kcal mixed meal stimulus
Time frame: Within 300 minutes post meal
Insulin area under the curve over 300 minutes after a 400kcal mixed meal stimulus
Time frame: Within 300 minutes post meal
Visual analogue scales
Time frame: Within 300 minutes post meal
EORTC health related quality of life
Time frame: At one year post surgery, on the day of assessment
Duodenal enteroendocrine cell density
Time frame: At one year post surgery, on the day of assessment
Duodenal enteroendocrine L-cell density
Time frame: At one year post surgery, on the day of assessment
Duodenal enteroendocrine cell mRNA expression profile
Time frame: At one year post surgery, on the day of assessment
Plan to share: No
Ran from Jul 2016 to primary completion in Jul 2021, 60 months.
Of 152 non-industry observational studies under Esophageal Neoplasms, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 252. This study's 60 months is below that.
Counting every sponsor, half of 174 studies reached it within 60 months; a quarter within 33 and three quarters within 252.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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St. James's Hospital, Ireland