Metoclopramide As An Adjunct To Small Bowel Capsule Endoscopy: Rate of Complete Evaluation And Affect on Transit Times
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Difference in Treatment vs. Placebo in Pill Capsule Completion Rates
研究概览
简要总结
Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled design. The outcomes to be assessed are capsule study completion rates, gastric transit time, small bowel transit time, and the effect of diabetes on pill capsule completion rates. The purpose of the study is to assess if metoclopramide given prior to pill capsule endoscopy has any effect on pill capsule completion rate, gastric transit time, small bowel transit time, and pill capsule completion rates in diabetes.
详细描述
Pill Capsule Endoscopy allows Gastroenterologists to visualize the mucosa of the small bowel beyond the reach of any endoscope and to an extent never before possible. It involves the ingestion of a small pill camera approximately the size of a large vitamin. 8 hours of images are transmitted to a sensor worn around the patient's waist. At the conclusion of the test, these images are downloaded to a computer for physician review. Meanwhile, the PillCam™ passes naturally through the digestive system and does not require retrieval.
Many of these pill capsule studies are incomplete due to failure of the pill capsule to reach the colon. Metoclopramide (brand name Reglan) is an anti-emetic that also has known pro-motility effects in the GI tract. The thought behind this study is that metoclopramide will increase the rate of passage of the pill capsule through the GI tract allowing a higher completion rate of the pill capsule studies.
Patients scheduled for pill capsule endoscopy will be approached on the morning of their procedure to inform them of the research study. After proper consent is obtained the patient will receive either 5 mg Metoclopramide, 10 mg Metoclopramide, or a placebo pill 30 minutes prior to their pill capsule study. The pill capsule camera records 8 hours worth of data. The patient will return at the conclusion of their study to turn in their recorder. The ordering gastroenterologist will then read the study. Information regarding pill capsule completion (pill capsule goes through the ileocecal valve), gastric transit time, and small bowel transit time will then be recorded and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •Men and women over the age of 18 undergoing pill capsule endoscopy to investigate unexplained rectal bleeding, anemia, iron deficiency, abdominal pain, altered bowel habits, and/or weight loss.
排除标准
- •Inability to sign consent for research participation
- •Inability to swallow PillCam™, placebo, or metoclopramide capsule
- •Known hypersensitivity/allergy to metoclopramide
- •Active congestive heart failure or respiratory failure requiring ventilator assistance
- •Presence of cardiac pacemaker or implanted electromedical device
- •Known bowel obstruction/stricture/fistula or intrauterine pregnancy
- •Known history of Whipple procedure (pancreaticoduodenectomy), Billroth II surgery (partial gastrectomy with gastrojejunostomy), or gastric bypass surgery due to risk of capsule retention in a blind intestinal limb necessitating surgical retrieval
- •Known history of seizure disorder, renal failure requiring dialysis, or pheochromocytoma
- •Lactating women
研究组 & 干预措施
Metoclopramide 5 mg
Pro-motility agent
干预措施: Metoclopramide (Drug)
Metoclopramide 10 mg
Pro-motility agent
干预措施: Metoclopramide (Drug)
Placebo control
Placebo to be used as the control group
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in Treatment vs. Placebo in Pill Capsule Completion Rates
时间窗: 12 hours
This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).
次要结局
- Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies(12 hours)
- Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics(12 hours)
- Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies(12 hours)
研究者
Steven Brooks
DO/Internal Medicine Resident
Ascension Health