Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Diagnostic	Active	18 and over	Other	05/CE/94 REC 05/Q0405/94, EudraCT No: 2005-004423-19, NCT00275184

Trial Description

Summary

The aim of this study is to determine whether taking bowel preparation (citramag and senna) or a medicine to speed up transit through the stomach (metoclopramide), will improve the quality of the images seen, increase the transit through the small bowel, and increase the rate of completion of capsule endoscopy. The secondary objective is to determine whether patients could routinely tolerate this bowel preparation prior to capsule endoscopy and whether the diagnostic yield of capsule endoscopy is improved.

Further Study Information

Capsule endoscopy is a diagnostic tool for the detection of small bowel disease allowing noninvasive endoscopic examination of the entire small bowel without the need for sedation. Its limited battery life of 8+/-1 hours means it is paramount that the Capsule reaches the caecum, visualizing the whole of the small intestine, and also that the mucosal views obtained are clear, facilitating detection of pathologic lesions.

So far no optimal protocol for bowel preparation prior to Capsule endoscopy has been established. Recently, several studies have shown that bowel preparation with polyethylene glycol significantly reduces both gastric and small bowel transit times. Similarly, visualization of the small intestine and therefore 'diagnostic yield' have both been shown to be improved by both sodium phosphate and polyethylene glycol preparation. A more recent study by Selby et al also demonstrates that the prokinetic agent metoclopramide (which is known to promote emptying of the stomach) reduced both stomach and small bowel transit time, increasing completion rates from 76% to 97%). The proposal is to perform a randomised, controlled study using Citramag and Senna bowel preparation or Metoclopramide to determine whether test completion rates are improved and whether the images of the bowel are of better quality.

The hypothesis is that the improved wall visibility and increased completion rates will improve the diagnostic yield of Capsule endoscopy and therefore improve patient care.

Eligibility Criteria

Inclusion Criteria:

• Patients over 18 who have been referred for capsule endoscopy

Exclusion Criteria:

• Under 18

• Known or suspected gastrointestinal tract obstruction as this may impede passage of the capsule

• Known small bowel stricture or fistula as this may impede capsule passage

• Pregnancy, breast feeding or phaeochromocytoma as metoclopramide is contraindicated

• Recent gastrointestinal surgery in view of the risk of impeded capsule passage

• Permanent cardiac pacemaker or implantable defibrillator in-situ to avoid the risk of possible interference

• Congestive cardiac failure as citramag is contraindicated in such patients

Trial Contact Information

Trial Lead Organizations/Sponsors

Northwick Park Hospital

Christopher Fraser, MB BCH, MD, FRCP

Principal Investigator

Christopher Fraser, MB BCH, MD, FRCP
		Email: chris.fraser@imperial.ac.uk

Neil Patterson, MB BCH, MD, MRCP
		Email: neil@rnpaterson.idps.co.uk

United Kingdom
	London
	St. Mark's Hospital
		Alan Warnes, PhD
			Email: alan.warnes@nwlh.nhs.ul
		Iva Hauptmannova, BSc, MA
			Email: iva.hauptmannova@nwlh.nhs.uk
		Neil Patterson, MB BCH, MD, MRCP	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00275184
Information obtained from ClinicalTrials.gov on March 18, 2009