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临床试验/NCT02385630
NCT02385630已完成不适用

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

St. James's Hospital, Ireland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

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
1
主要终点
Post-prandial satiety gut hormone area under the curve

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Patients scheduled to undergo two-stage, three-stage or transhiatal oesophagectomy with gastric conduit reconstruction OR total gastrectomy with Roux-en-Y reconstruction

排除标准

  • •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

研究组 & 干预措施

Esophagectomy

Experimental

Serial assessment:

Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal

干预措施: Standardized 400kcal semi-liquid meal (Other)

Gastrectomy

Experimental

Serial assessment:

Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal

干预措施: Standardized 400kcal semi-liquid meal (Other)

结局指标

主要结局

Post-prandial satiety gut hormone area under the curve

时间窗: 1 year

次要结局

  • Body anthropometry(1 year)
  • EORTC health related quality of life at one year(1 year)
  • Subjective symptom scores(1 year)
  • Fasting ghrelin concentration(1 year)

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

Surgical Research Fellow

St. James's Hospital, Ireland

研究点 (1)

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