Can Steerable Capsule Endoscopy Enhance Gastric Emptying?

Not Applicable

Completed

• Conditions: Patients Attending Hospital for Small Bowel Endoscopy
• Interventions: Device: Magnetically steerable capsule endoscopy; Device: Wireless Capsule Endoscopy

• Registration Number: NCT02282852
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-10
• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetically steerable capsule endoscopy	Magnetically steerable capsule endoscopy	A handheld magnet (manufactured by Intromedic Ltd.) has been developed to allow some control of the pill camera (that contains a small amount of magnetic material) 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.
Wireless Capsule Endoscopy	Wireless Capsule Endoscopy	Wireless capsule endoscopy is the investigation modality of choice for suspected diseases of the small bowel. A small pill-sized capsule contianing a camera is swallowed by the patient. The procedure is safe and non-invasive. Normally, the pill camera travels through the gut an exits the bowel via natural means. In a small number of cases the capsule is maintained. If the capsule is still in the stomach, mobilisation is encouraged followed by an intramuscular pro-kinetic injection if this fails.

Primary Outcome Measures

Name	Time	Method
Duration of time taken for camera capsule to enter duodenum.	Baseline
Completion rate of small bowel endoscopy examination	Baseline

Trial Locations

Locations (1)

Royal Hallamshire Hospital; 🇬🇧 Sheffield, South Yorkshire, United Kingdom