Track topics on Twitter Track topics that are important to you
Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the small bowel. The small bowel is about 4 meters long. The battery time of the capsule is about 8 hours. During this time the capsule takes pictures as it passes through the small bowel. In about 15-20% of capsule tests the battery expires before the capsule passes through the entire small bowel into the colon. Incomplete tests indicate that a variable portion of small bowel was not visualized. Incomplete tests are associated with potential missing of abnormalities in the portion of small bowel that was not reached. The capsule test may often required to be repeated but the problem of incomplete examination may persist. At present no medication has been approved to increase the rate of complete capsule tests.
Prucalopride is a medication that has been approved in Canada and Europe for the treatment of chronic idiopathic constipation. Animal and human studies suggested that prucalopride may enhance the movement of the stomach and the small bowel. A recent presentation at a medical meeting suggested that prucalopride may accelerate the passage of the capsule camera through the small bowel without increasing the chance to miss a lesion in the small bowel.
The purpose of this study is to asses if the administration of a single dose of prucalopride is going to decrease the time required by the capsule to move through the small bowel.
Capsule Endoscopy is now the first test to investigate for small bowel disease. Clinical conditions in which capsule endoscopy can be useful include gastrointestinal bleeding of unclear source, Crohn's disease, celiac disease and suspected small bowel tumors. Optimal diagnostic yield of the capsule endoscopy depends not only on adequate small bowel visualization, but also on the completion of small bowel examination. In approximately 15-20% of capsule studies, the capsule fails to pass through the small bowel into the colon because of the limited battery time which is about 8 hours. This means that a lesion or an abnormality can be missed in the portion of the small bowel that was not reached by the capsule. As a result, the capsule endoscopy test may often need to be repeated.
Multiple factors have been associated with the prolongation of the time required for the capsule to pass through the small bowel including hospitalization, prior small bowel surgery, diabetes and advanced age in addition to the prolongation of the time required for the capsule to pass through the stomach. Interventions to shorten small bowel transit time are required to increase capsule small bowel completion rates. At present there is no drug approved to shorten the small bowel transit time.
Prucalopride is a drug that has been approved for use in patients with chronic constipation. Prucalopride works on special receptors in the gut and stimulate the gut movement. There are basic and clinical studies suggesting that prucalopride may accelerate the movement of the stomach and the small bowel. Therefore, prucalopride may accelerate the passage of the capsule through the small bowel and increase the capsule completion rates. We recently presented our experience of prucalopride use prior to capsule endoscopy at a medical meeting. Compared to a retrospective control group who did not receive prucalopride, prucalopride accelerated the passage of the capsule through the small bowel. There was no decrease in the diagnostic yield in the group who received prucalopride.
In this clinical trial, we aim to investigate the effect of prucalopride on the small bowel transit time, by performing a randomized placebo controlled trial. Patients undergoing small bowel capsule endoscopy tests will be randomized to a single dose of prucalopride ingested at the time of capsule endoscopy ingestion, or a placebo pill. The primary objective of this study is to examine if the administration of a single dose of prucalopride shortens small bowel transit time compared to placebo. The secondary objectives include examining the effect of prucalopride on gastric transit time, small bowel capsule endoscopy completion rate and the capsule diagnostic yield. The placebo group is used in this clinical trial because there is no drug proven to be effective to shorten the small bowel transit time.
From our experience, the average small bowel transit time for patients who were given prucalopride was 143 minutes. In the retrospective control group, the small bowel transit time was 229 minutes with a standard deviation of 90 minutes. Based on a presumed 20% minimal clinically important difference in small bowel transit time, we determined a total of 122 participants will be required, equally divided between the two study arms.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Vancouver General Hospital
Not yet recruiting
University of British Columbia
Published on BioPortfolio: 2016-06-20T18:53:21-0400
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation Hypothesis: Prucalopride 2 mg and 4 mg given once dail...
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation. Hypothesis: Prucalopride 2 mg and 4 mg given once dai...
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation in elderly patients. Hypothesis: Prucalopride 2 mg and...
The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic constipation. Hypothesis: Prucalopride 1 and 2 mg bid are safe a...
The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic idiopathic constipation. Hypothesis: Prucalopride 1 and 2 mg are...
We aimed to determine the rate of hospital readmission within 30 days of non-variceal upper gastrointestinal hemorrhage (NVUGIH) and its impact on mortality, morbidity and healthcare utilization in th...
Comparison of the efficacy of intravenous tranexamic acid with and without topical administration versus placebo in urgent endoscopy rate for acute gastrointestinal bleeding: A double-blind randomized controlled trial.
Tranexamic acid (TXA), a synthetic antifibrinolytic drug, is effective as a treatment for serious hemorrhage, including bleeding arising from major trauma and post-operative interventions. Significant...
BACKGROUND Ovarian cancer is the second most common malignant tumor of the female reproductive system and is the leading cause of death of gynecological malignancies, but at present there is no effect...
The objective of this study was to compare the efficacy and side effects of acupuncture, sham acupuncture and drugs in the treatment of chronic constipation. Randomized controlled trials (RCTs) assess...
Intracranial hemorrhage, such as intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH) and intraventricular hemorrhage (IVH) is an extremely rare complication after surgical revascularization ...
Bleeding in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM.
Acquired degenerative dilation or expansion (ectasia) of normal BLOOD VESSELS, often associated with aging. They are isolated, tortuous, thin-walled vessels and sources of bleeding. They occur most often in mucosal capillaries of the GASTROINTESTINAL TRACT leading to GASTROINTESTINAL HEMORRHAGE and ANEMIA.
Bleeding from a PEPTIC ULCER that can be located in any segment of the GASTROINTESTINAL TRACT.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Hemorrhage within the orbital cavity, posterior to the eyeball.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...