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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 examination

Duration 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

Page last updated: August 23, 2015

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