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临床试验/NCT03734627
NCT03734627已完成不适用

Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery

St. James's Hospital, Ireland2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Area under the curve for paracetamol at 30 minutes after a 400kcal mixed meal stimulus

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient group:
  • History of upper gastrointestinal surgery at least 9 months previously
  • Control group:
  • Patients with suspected or confirmed non-dysplastic Barrett's oesophagus or reflux who are age, weight and gender matched to the patient cohort

排除标准

  • 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
  • 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.

研究组 & 干预措施

Upper Gastrointestinal Surgery - Transit

干预措施: Octreotide Acetate (Drug)

Upper Gastrointestinal Surgery - Transit

干预措施: Saline Solution (Drug)

Upper Gastrointestinal Surgery - Transit

干预措施: Paracetamol (Drug)

Upper Gastrointestinal Surgery - Transit

干预措施: Sulfasalazine (Drug)

Control - Transit

干预措施: Octreotide Acetate (Drug)

Control - Transit

干预措施: Saline Solution (Drug)

Control - Transit

干预措施: Paracetamol (Drug)

Control - Transit

干预措施: Sulfasalazine (Drug)

Upper Gastrointestinal Surgery - Gut Function

干预措施: Duodenal biopsy (Diagnostic Test)

Control - Gut Function

干预措施: Duodenal biopsy (Diagnostic Test)

结局指标

主要结局

Area under the curve for paracetamol at 30 minutes after a 400kcal mixed meal stimulus

时间窗: 30 minutes post meal

次要结局

  • Peak paracetamol level(Within 300 minutes post meal)
  • GLP-1 area under the curve over 300 minutes after a 400kcal mixed meal stimulus(Within 300 minutes post meal)
  • EORTC health related quality of life(At one year post surgery, on the day of assessment)
  • Glucose area under the curve over 300 minutes after a 400kcal mixed meal stimulus(Within 300 minutes post meal)
  • Insulin area under the curve over 300 minutes after a 400kcal mixed meal stimulus(Within 300 minutes post meal)
  • Visual analogue scales(Within 300 minutes post meal)

研究者

发起方
St. James's Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jessie A Elliott

Clinical Research Fellow

St. James's Hospital, Ireland

研究点 (2)

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