Small Bowel Diseases Clinical Trial
Official title:
A Double Blind Randomized Controlled Trial of High Volume Simethicone to Improve Visualization During Capsule Endoscopy
Video capsule endoscopy (VCE) is a procedure where a small camera is swallowed to examine the small bowel. Although the procedure is useful for diagnosing small bowel diseases, air bubbles can obscure the recorded images. Simethicone is a medication that can be used to disperse the air bubbles. However, prior studies using this medication have shown only a modest benefit. In our study, we would like to investigate whether increasing the amount of medication will improve the recorded images further.
BACKGROUND:
While VCE has become an important diagnostic tool for clinical practice, optimal preparation
for VCE has yet to be determined.(13) The European Society of Gastrointestinal Endoscopy
recommends bowel preparation but does not provide further details.(2) The Canadian
Association of Gastroenterology, American Society of Gastrointestinal Endoscopy, American
College of Gastroenterology, and American Gastroenterological Association make no specific
recommendation. Many studies have addressed this knowledge gap, testing various regimens of
purgatives.(14-18) A meta-analysis found that polyethylene glycol provided adequate visual
quality in 68% of patients compared to 48% with fasting alone, while diagnostic yield climbed
from 36% to 46%.(4) In contrast, oral preparation for colonoscopy produces adequate
visualization in greater than 90% of patients.(19)
Intraluminal debris, bile, and air bubbles impair the visibility of small bowel mucosa during
VCE. Simethicone, an anti-foaming agent, has been used with mixed success to improve image
quality. Three studies investigated the addition of simethicone (30 mg, 600 mg, and 800 mg)
to overnight fast, PEG, or mannitol demonstrated improvement in visualization with high
preparation scores favouring the addition of simethicone.(7-9) In contrast, Wei and
colleagues (10) compared simethicone (300 mg) + PEG with PEG alone and found that although
simethicone improved visualization, adequate visualization was achieved in only 63% of
patients. Similarly, Ge et al. (11) compared simethicone (300 mg) against fasting alone and
found improvement in visualization with simethicone but this was limited to the proximal half
of the small bowel and adequate visualization was limited to 55% of cases. Lastly, Rosa et
al. (12) compared simethicone (100 mg) + PEG with PEG alone and did not find a difference in
visualization score.
A potential reason for inconsistent improvement in small bowel visualization may be due to an
inadequate volume of simethicone being delivered into the small bowel, especially the distal
portions. Prior volumes of simethicone were small (<200 ml) and may have pooled in the
stomach and become diluted by gastric juices before being delivered into the duodenum. Our
hypothesis is that high volume simethicone may overcome this problem and improve small bowel
cleansing to facilitate improved visualization during VCE.
STUDY DESIGN:
This is a double blind randomized clinical trial evaluating high volume simethicone (750 ml
at 1.5 mg/ml) versus standard volume simethicone (200 ml at 1.5 mg/ml) for CE. Randomization
will be performed in blocks of varying sizes through a web based interface, Research
Electronic Data Capture (REDCap), to ensure concealed allocation. Patients, physicians, and
outcome assessors will be blinded to randomization allocation.
INTERVENTION:
All patients will take a standard small bowel preparation consisting of the following
starting the day before the procedure: clear fluids starting at lunch, two liters of PEG at 8
PM, and fasting starting at midnight. Patients arrive in the endoscopy unit at 6:45 AM the
following morning. Randomization is performed via REDCap and simethicone given as follows:
those randomized to high volume simethicone will drink a 750 ml solution (1125 mg simethicone
diluted in 750 ml of water, 1.5 mg/ml) and those randomized to standard volume simethicone
will drink a 200 ml solution (300 mg simethicone diluted in 200 ml of water, 1.5 mg/ml) in
identical non-transparent lidded cups sealed with tamper tape prepared by the hospital's
Clinical Trials Pharmacy and administered to the patient by the research nurse. Regardless of
randomization results, the solution will be consumed over a 5 minute period and the patient
instructed to resume fasting for 30 minutes before swallowing the capsule. Adherence will be
assessed by collection of the cups after ingestion.
After swallowing the capsule, the patient is discharged from the endoscopy unit, encouraged
to remain active for the day, allowed to have clear fluids in 2 hours, a light meal in 4
hours, and to return the CE recorder to the endoscopy unit at 5 PM. Once the CE recorder is
returned, the patient is discharged from the endoscopy unit and has completed the study.
Subjects will be called by the study nurse 7 days later to assess for adverse events.
CE will be performed with the Given Imaging SB3 capsule and reviewed with the accompanying
software, RAPID v8.3. Videos will be reviewed in a blinded fashion without knowledge of
randomization results using the Park score.(41)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
NCT02275858 -
Enteroscopy Stiffening Device for Retrograde Balloon Assisted Enteroscopy
|
N/A |