Can Steerable Capsule Endoscopy Enhance Gastric Emptying?
Information source: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patients Attending Hospital for Small Bowel Endoscopy
Intervention: Wireless Capsule Endoscopy (Device); Magnetically steerable capsule endoscopy (Device)
Phase: N/A
Status: Completed
Sponsored by: Sheffield Teaching Hospitals NHS Foundation Trust Official(s) and/or principal investigator(s): Mark McAlindon, MD, Principal Investigator, Affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
Summary
Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected
diseases of the small bowel. The procedure is safe and noninvasive, the main risk being
capsule retention occurring in approximately 2% of procedures. Other problems such as
incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric
emptying, slow small bowel transit, faulty equipment and poor bowel preparation.
Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime'
viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an
intramuscular prokinetic injection if this fails. This approach has disadvantages since an
intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly
used for this purpose, has a risk of acute dystonic reactions particularly in young
patients.
Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the
capsule in the upper GI tract. We propose that this could be used, alongside positional
changes, to expedite capsule transit through the stomach thus improving completion rates and
avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled
study comparing a standard protocol for small bowel capsule endoscopy against a hand held
magnet and positional change protocol to enhance gastric emptying of the wireless capsule.
Clinical Details
Official title: Randomised Comparison of a Standard Protocol Using Metoclopramide Versus a Hand Held Magnet to Enhance Gastric Emptying of the Small Bowel Capsule.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Primary outcome: Completion rate of small bowel endoscopy examinationDuration of time taken for camera capsule to enter duodenum.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients aged 20 years or over
- Patients attending hospital for small bowel endoscopy examination
Exclusion Criteria:
- Patients under the age of 20 years
- Patients with a permanent pacemaker, or implantable cardioverter-defibrillator
- Patients with any electronic/magnetic/mechanically controlled devices
- Patients that are pregnant
- Patients who are unable to understand or speak English
Locations and Contacts
Royal Hallamshire Hospital, Sheffield, South Yorkshire S10 2JF, United Kingdom
Additional Information
Starting date: January 2014
Last updated: March 20, 2015
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