Esophageal CancerEndoGutNCT03734627
Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery
An observational study of Esophageal Cancer and Nutrition Disorders, run by St. James's Hospital, Ireland at 2 sites in Ireland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer, Nutrition Disorders, Appetite Disorders
- What is being tested?
- Octreotide Acetate, Saline Solution and Paracetamol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 40 participants
- Where
- 2 sitesIreland
- Study dates
- 1 Jul 2016to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patient group:
- 1. History of upper gastrointestinal surgery at least 9 months previously
- Control group:
- 1. Patients with suspected or confirmed non-dysplastic Barrett's oesophagus or reflux who are age, weight and gender matched to the patient cohort
Who cannot join
- Pregnancy, breastfeeding
- Recurrent disease after surgery
- Other active malignancy
- Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent
- Other disease or medication which may impact gut hormone physiology
- Previous upper gastrointestinal resection
Show all 9Show fewer
- Certain allergies or dietary intolerances
- Anticoagulants
- Patients with contraindications 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.
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Department of Surgery, St. James's Hospital
Dublin, D4
Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Dublin, D8
About this study
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.
Read more
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.
- Conditions
- Esophageal Cancer, Nutrition Disorders, Appetite Disorders, Dumping Syndrome, Delayed Gastric Emptying, Surgery
- Being tested
- Octreotide Acetate, Saline Solution, Paracetamol, Sulfasalazine, Duodenal biopsy
- Keywords
- Gut hormones, GLP-1, Enteroendocrine L-cell, Early satiety, Dumping syndrome, Gastrointestinal transit, Insulin, Octreotide, Somatostatin, Esophagectomy
- Medical subject headings
- Esophageal Neoplasms, Nutrition Disorders, Feeding and Eating Disorders, Dumping Syndrome, Gastroparesis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide AcetateDrug
50mcg octreotide acetate by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge
Saline SolutionDrug
Equivalent volume of 0.9% saline by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge
ParacetamolDrug
Paracetamol 1g by mouth consumed with a 400kcal mixed meal challenge
SulfasalazineDrug
1g sulfasalazine by mouth consumed with a 400kcal mixed meal challenge
Duodenal biopsyDiagnostic test
Biopsy from the second part of the duodenum taken at routine endoscopic surveillance, undertaken for another clinical indication.
| Study group | Role | What they receive |
|---|---|---|
| Upper Gastrointestinal Surgery - Transit | Not described Receives: Drug: Octreotide Acetate; Drug: Saline Solution; Drug: Paracetamol; Drug: Sulfasalazine | |
| Control - Transit | Not described Receives: Drug: Octreotide Acetate; Drug: Saline Solution; Drug: Paracetamol; Drug: Sulfasalazine | |
| Upper Gastrointestinal Surgery - Gut Function | Not described Receives: Diagnostic Test: Duodenal biopsy | |
| Control - Gut Function | Not described Receives: Diagnostic Test: Duodenal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for paracetamol at 30 minutes after a 400kcal mixed meal stimulus
Measured: 30 minutes post meal
Secondary outcomes (6)
Peak paracetamol level
Measured: Within 300 minutes post meal
GLP-1 area under the curve over 300 minutes after a 400kcal mixed meal stimulus
Measured: Within 300 minutes post meal
Glucose area under the curve over 300 minutes after a 400kcal mixed meal stimulus
Measured: Within 300 minutes post meal
Insulin area under the curve over 300 minutes after a 400kcal mixed meal stimulus
Measured: Within 300 minutes post meal
Visual analogue scales
Measured: Within 300 minutes post meal
EORTC health related quality of life
Measured: At one year post surgery, on the day of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jul 2016
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jessie A Elliott, St. James's Hospital, Ireland
- Investigators
- John V Reynolds, MD FRCS, Principal investigator, St. James's Hospital, Dublin, IrelandCarel W le Roux, FRCP FRCPath PhD, Principal investigator, Conway Institute of Biomolecular and Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734627
- Sponsor's protocol ID
- CRFSJ075 and 0095
- Other IDs
- 2016-02-CA(9), 2016-03-11(1)
- Acronym
- EndoGut
- Status last verified
- Aug 2021
- First submitted
- 6 Nov 2018
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elliott JA, Docherty NG, Eckhardt HG, Doyle SL, Guinan EM, Ravi N, Reynolds JV, Roux CWL. Weight Loss, Satiety, and the Postprandial Gut Hormone Response After Esophagectomy: A Prospective Study. Ann Surg. 2017 Jul;266(1):82-90. doi: 10.1097/SLA.0000000000001918.
PubMed 27455150Elliott JA, Jackson S, King S, McHugh R, Docherty NG, Reynolds JV, le Roux CW. Gut Hormone Suppression Increases Food Intake After Esophagectomy With Gastric Conduit Reconstruction. Ann Surg. 2015 Nov;262(5):824-29; discussion 829-30. doi: 10.1097/SLA.0000000000001465.
PubMed 26583672
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT03734627
- Acronym / sponsor ID
- EndoGut / CRFSJ075 and 0095
- Conditions
- Esophageal Cancer, Nutrition Disorders, Appetite Disorders, Dumping Syndrome, Delayed Gastric Emptying, Surgery
- Keywords
- Gut hormones, GLP-1, Enteroendocrine L-cell, Early satiety, Dumping syndrome, Gastrointestinal transit, Insulin, Octreotide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Upper Gastrointestinal Surgery - Transit | – | Drug: Octreotide Acetate, Drug: Saline Solution, Drug: Paracetamol, Drug: Sulfasalazine |
| Control - Transit | – | Drug: Octreotide Acetate, Drug: Saline Solution, Drug: Paracetamol, Drug: Sulfasalazine |
| Upper Gastrointestinal Surgery - Gut Function | – | Diagnostic Test: Duodenal biopsy |
| Control - Gut Function | – | Diagnostic Test: Duodenal biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 1. History of upper gastrointestinal surgery at least 9 months previously
- 1. Patients with suspected or confirmed non-dysplastic Barrett's oesophagus or reflux who are age, weight and gender matched to the patient cohort
Key exclusion criteria (9 listed)
- Pregnancy, breastfeeding
- Recurrent disease after surgery
- Other active malignancy
- Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent
- Other disease or medication which may impact gut hormone physiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide Acetate50mcg octreotide acetate by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge | Drug | Control - Transit, Upper Gastrointestinal Surgery - Transit |
| Saline SolutionEquivalent volume of 0.9% saline by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge | Drug | Control - Transit, Upper Gastrointestinal Surgery - Transit |
| ParacetamolParacetamol 1g by mouth consumed with a 400kcal mixed meal challenge | Drug | Control - Transit, Upper Gastrointestinal Surgery - Transit |
| Sulfasalazine1g sulfasalazine by mouth consumed with a 400kcal mixed meal challenge | Drug | Control - Transit, Upper Gastrointestinal Surgery - Transit |
| Duodenal biopsyBiopsy from the second part of the duodenum taken at routine endoscopic surveillance, undertaken for another clinical indication. | Diagnostic test | Control - Gut Function, Upper Gastrointestinal Surgery - Gut Function |
Primary outcome
Area under the curve for paracetamol at 30 minutes after a 400kcal mixed meal stimulus
Time frame: 30 minutes post meal
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Background: PubMed 27455150Elliott JA, Docherty NG, Eckhardt HG, Doyle SL, Guinan EM, Ravi N, Reynolds JV, Roux CWL. Weight Loss, Satiety, and the Postprandial Gut Hormone Response After Esophagectomy: A Prospective Study. Ann Surg. 2017 Jul;266(1):82-90. doi: 10.1097/SLA.0000000000001918.
- Background: PubMed 26583672Elliott JA, Jackson S, King S, McHugh R, Docherty NG, Reynolds JV, le Roux CW. Gut Hormone Suppression Increases Food Intake After Esophagectomy With Gastric Conduit Reconstruction. Ann Surg. 2015 Nov;262(5):824-29; discussion 829-30. doi: 10.1097/SLA.0000000000001465.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John V Reynolds, MD FRCS principal investigator
St. James's Hospital, Dublin, Ireland
Carel W le Roux, FRCP FRCPath PhD principal investigator
Conway Institute of Biomolecular and Biomedical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Nutrition Disorders, run by St. James's Hospital, Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve for paracetamol at 30 minutes after a 400kcal mixed meal stimulus (time frame: 30 minutes post meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03734627, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.