Study of Metoclopramide in Small Bowel Capsule Endoscopy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | July 2012 |
| Contact: | Steven D Brooks, D.O. |
| Email: | Steven.Brooks@genesys.org |
| Phone: | 989-277-8162 |
Metoclopramide As An Adjunct To Small Bowel Capsule Endoscopy: Rate of Complete Evaluation And Affect on Transit Times
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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