Gastric Preparation of Magnetic-controlled Capsule Endoscopy: A Prospective, Single Blinded and Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the level of gastric cleansing
研究概览
简要总结
By using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the investigators hope to find out the optimal gastric preparation plan.
详细描述
It is a prospective, single-blind, randomized controlled trial. Patients who were conducted by Magnetic-controlled Capsule Endoscopy at Changhai Hospital will be randomly allocated into three different Gastric Preparation group before the procedure. It include clear water group which patient only drink 1000ml clear water before checking; simethicone group which patient drink 950ml clear water and 15ml simethicone before checking; simethicone combined with pronase group which patient drink 900ml lear water and 15ml simethicone and 20，000iu pronase before checking. The result were got from a relevant professional physician's blinded independent image-reading.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients aged 16-75 years, who were scheduled to undergo a Magnetic-controlled Capsule Endoscopy, were eligible for this study.
排除标准
- •Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation;
- •Congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves;
- •Pregnancy or suspected pregnancy;
- •Exclusion criteria for standard magnetic resonance imaging (MRI) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices;
- •Currently participating in another clinical study.
研究组 & 干预措施
clear water group
the patients only drink 1000ml clear water before checking
干预措施: clear water (Other)
simethicone group
the patients drink 950ml clear water and 15ml simethicone before checking
干预措施: simethicone (Drug)
simethicone combined with pronase group
the patients drink 900ml clear water and 15ml simethicone and 20，000iu pronase before checking
干预措施: simethicone combined with pronase (Drug)
结局指标
主要结局
the level of gastric cleansing
时间窗: 4 month
Two investigators who did not know which kind of gastric preparation of the patient scored the level of gastric cleansing 0f 120 participants according to a four-point grading scale: poor, fair, good, and excellent，which was pointed 3,2,1，and 0.The investigators should evaluate the gastric cleansing of six anatomical landmarks (cardia, fundus, body, angulus, antrum and pylorus).A poor level of cleansing indicated the mucosa was obscured largely by a lot of air bubbles and grume,fair indicated that a portion of the mucosa was obscured by air bubbles and grume that was enough to prevent a reliable visualization of polyps, good indicated that a small amount of air bubbles and grume，and excellent indicated that the fluid was clear and the image was either free or had only small bits of air bubbles and grume.
次要结局
- the time of gastric examination(4 month)
- Transit time(4 month)
- Diagnostic yield of Magnetic-controlled Capsule Endoscopy(4 month)
- Tolerability of participants(4 month)
- the visibility of gastric(4 month)
- the added amount of water of the whole process during gastric examination(4 month)
研究者
Zhuan Liao
M.D., Associate Professor, Associate Chief Physician
Changhai Hospital