Comparative Validity of 99mTc-pertechnetate SPECT/CT and Mean Intragastric Pressure During Nutrient Drink in the Measurement of Gastric Accommodation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of adverse event
研究概览
简要总结
Functional dyspepsia (FD) is a common gastrointestinal disorder which can present with early satiety, postprandial fullness, epigastric pain and burning sensation in the absence of underlying disease. The most troubling symptom is weight loss, prevalent in up to 40% of FD patients and is often associated with impaired gastric accommodation.
Gastric accommodation by definition is a reflex, mediated vagally which causes reduction in gastric tone, increased in compliance and increment in gastric volume post meal ingestion. It allows large volumes of liquid or solid ingestion without causing postprandial symptoms. Impairment of gastric accommodation has been linked to gastrointestinal symptoms which includes nausea, bloating, early satiety, weight loss and epigastric pain.
There are several studies aimed to assess efficacy in the treatment of functional dyspeptic patients. A myriad of tests can measure gastric accommodation such as gastric barostat and single photon emission computed tomography (SPECT). An alternative study known as the nutrient drink test has also been proposed and can be combined with high-resolution manometry.
So far, none of the nuclear medicine centers in Malaysia are providing clinical service for radionuclide gastric accommodation study. The gold standard for gastric accommodation assessment is the gastric barostat method. However, the technique is invasive and caused discomfort to patients. Radionuclide gastric accommodation study using 99mTc-pertechnetate with SPECT/CT is a non-invasive method that can be used to assess patient with FD and enables quantitative evaluation of treatment response to medications. Hence, the role of non-invasive gastric volume assessment with 99mTc-pertechenate SPECT/CT in the evaluation of healthy individuals was studied first, and then compared with intragastric pressure measurements from high-resolution manometry and nutrient drink test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Inclusion Criteria:
- •Patient is above 18 years-old.
- •No current gastrointestinal symptoms
- •No previous gastrointestinal illness such as peptic ulcer disease or gastritis
- •No chronic medical illness such as chronic neurological, cardiovascular, pulmonary, endocrine and hematological disorders
- •Does not fulfill Rome IV criteria for functional dyspepsia
排除标准
- •• Had undergone any abdominal surgery except appendicectomy, tubal ligation or Caesarean section
- •Use of medications such as metoclopramide, domperidone, erythromycin and itopride that may alter gastrointestinal function and motility
- •Pregnant woman
结局指标
主要结局
Incidence of adverse event
时间窗: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
• Tolerability assessed as incidence of adverse event over study period using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Number of participants completing each procedure
时间窗: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
• Feasibility assessed as technical success (number of participants completing each procedure).
Duration (time) of each procedural session
时间窗: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
• Feasibility assessed as procedural duration (time taken to complete one procedure)
次要结局
- Gastric volume measured using SPECT/CT(During the procedure, 1 day)
- Proximal gastric pressure measured using high-resolution manometry(During the procedure, 1 day)
- Nutrient drink tolerance(During the procedure, 1 day)
- Dyspeptic symptoms measured using numerical rating scales(During the procedure, 1 day)
- Satiation score measured using numerical rating scales(During the procedure, 1 day)
研究者
Nashrulhaq Tagiling, MSc
Principal Investigator
Universiti Sains Malaysia