Differences in Preparation for Small Bowel Capsule Endoscopy

• ClinicalTrials.gov Identifier: NCT03351972
• Recruitment Status: Recruiting
• First Posted: November 24, 2017
• Last Update Posted: April 4, 2019
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborator: Hotel Dieu Hospital
• Information provided by (Responsible Party): Sheffield Teaching Hospitals NHS Foundation Trust

Study Description

Brief Summary:

The introduction of video capsule endoscopy in 2000 has provided a convenient and minimally invasive imaging method for the whole small bowel. Capsule Endoscopy is used to investigate a number of conditions such as obscure gastrointestinal bleeding, iron deficiency anaemia, inflammatory bowel disease, celiac disease, small bowel tumors, and hereditary polyposis syndromes. However, Capsule Endoscopy capsules are not able to suction fluid or wash the intestine, thus making it susceptible to decreased visualization quality and diagnostic yield due to dark intestinal contents or air bubbles. In order to determine the best method for bowel preparation before Capsule Endoscopy, this study seeks to determine in patients undergoing small intestine Capsule Endoscopy if split dose Polyethylene Glycol or single morning dose of Polyethylene Glycol have a benefit in Visualisation quality when compared to clear fluids only. A co-primary outcome will also be the diagnostic yield, as measured by the aggregate of all the active preparation groups compared to than clear fluids only group. Secondary outcome measures will include tolerance of preparations, cleanliness as assessed by a validated 4 point scale, distal small bowel visualization (the last 1/4 of small bowel examination by time) and small bowel transit time (measured as time from first duodenal image to first cecal image). Adult outpatients referred for small bowel video capsule endoscopy will be considered for the study and this will run in the clinical environment as per routine. Patients will have been referred for capsule endoscopy as per normal clinical practice so not additional procedure will take place. Patients will be randomly assigned to in a one to one fashion to one of three groups in order to explore whether bowel preparation (either as a single or divided dose) produce better cleansing and diagnostic yield than no preparation at all in small bowel capsule endoscopy.

Condition or disease	Intervention/treatment	Phase
Capsule Endoscopy; Inflammatory Bowel Diseases; Celiac Disease	Drug: Klean Prep; Other: Clear liquids only	Phase 4

Detailed Description:

In order to determine the best method for bowel preparation before Capsule Endoscopy, this study seeks to determine in patients undergoing small intestine Capsule Endoscopy if split dose Polyethylene Glycol or single morning dose of Polyethylene Glycol have a benefit in Visualisation quality when compared to clear fluids only. A co-primary outcome will also be the diagnostic yield, as measured by the aggregate of all the active preparation groups compared to than clear fluids only group. Secondary outcome measures will include tolerance of preparations, cleanliness as assessed by a validated 4 point scale, distal small bowel visualization (the last 1/4 of small bowel examination by time) and small bowel transit time (measured as time from first duodenal image to first cecal image).

Group Assignment:

The groups will have some common instructions: all groups will be instructed to stop iron supplements five days prior to the exam. On the day prior to the exam, patients will be instructed to have a light breakfast and lunch, followed by only clear fluids. Over the day, patients will be encouraged to have at least two litres of clear fluids. On the day of the exam, 80 mg of oral simethicone will be given 10 minutes prior to the exam. The capsule will be ingested at 9:00am, after which fluids may be consumed 2 hours later, and solid food 4 hours later. Patients will be randomly assigned to in a one to one fashion to one of three groups using a central online randomization program. The groups for this project include:

A. Control: no additional instructions beyond those above will be given. B. Single dose Polyethylene Glycol: Patients will take 2 litre of Polyethylene Glycol at 6am the day of the exam.

C. Split dose Polyethylene Glycol: Patients will take 1 litre of Polyethylene Glycol at 7pm the evening prior to the exam and 1 litre at 6am the day of the exam.

Recruitment of patients will be performed from outpatient gastroenterology clinics at Sheffield Teaching Hospitals NHS Trust. After a request for Capsule Endoscopy from a referring physician, the patient will be contacted by telephone by one of the Capsule endoscopy nurse specialists (who are also involved in the study) as per normal practice. The study will be discussed, the procedure explained and a convenient date for the procedure will be agreed with the patient. The patient will be invited to meet with one of the research staff at a mutually agreed time in order to go through the study once more and provide written consent should they agree to participate. Should they wish to participate but would prefer to complete a postal consent form, this will be arranged. The procedure will be completed according to normal practice. Patients will be advised that they can withdraw from the study at any point and choose a preferred option for bowel preparation

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Does Bowel Preparation (Either as a Single or Divided Dose) Produce Better Cleansing and Diagnostic Yield Than no Preparation at All in Small Bowel Capsule Endoscopy
• Actual Study Start Date: November 23, 2017
• Estimated Primary Completion Date: November 1, 2019
• Estimated Study Completion Date: December 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Bowel Prep routine; Participants randomised to this arm will receive their bowel prep (Klean Prep) with the routine guidance of taking the contents the day before their capsule endoscopy	Drug: Klean Prep; Participants randomised to use polyethylene glycol will follow either routine guidance of taking the bowel prep the night before their capsule endoscopy or receive guidance that they should split their dose between the night before and the morning of the procedure; Other Name: Polyethylene Glycol
Active Comparator: Bowel Prep Split; Participants randomised to this arm will receive their bowel prep (Klean Prep) with the guidance stating to take the first dose the day before the capsule endoscopy and the second dose the morning of the capsule endoscopy	Drug: Klean Prep; Participants randomised to use polyethylene glycol will follow either routine guidance of taking the bowel prep the night before their capsule endoscopy or receive guidance that they should split their dose between the night before and the morning of the procedure; Other Name: Polyethylene Glycol
Experimental: No bowel prep; Participants randomised to this arm will be advised to drink clear liquids only ahead of their capsule endoscopy procedure	Other: Clear liquids only; Participants randomised to clear liquids only will receive guidance to only drink clear liquids before their procedure

Outcome Measures

Primary Outcome Measures :

1. Clinician assessed Visual Quality of small bowel [ Time Frame: 1 day ]
   Visual quality of the small bowel during capsule endoscopy as assessed by a clinician
2. clinician assessed Diagnostic yield during capsule endoscopy [ Time Frame: 1 day ]
   Ability to produce a diagnosis following capsule endoscopy as assessed by a clinician

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Adult outpatients (18 years or older)
• routinely referred for small bowel video capsule endoscopy (CE)

Exclusion Criteria:

• dysphagia
• severe gastroparesis requiring endoscopic placement of capsule
• small bowel obstruction
• pregnancy

Contacts and Locations

Contacts

Contact: Mark McAlindon, MD; 0114 2711899; Mark.McAlindon@sth.nhs.uk

Contact: Luke Barron, Mr; 0114 2711899; Luke.Barron@sth.nhs.uk

Locations

Canada, Ontario

Hotel Dieu Hospital; Recruiting

Kingston,, Ontario, Canada

Contact: Laurence Hookey, MD hookeyl@hdh.kari.net

United Kingdom

Royal Hallamshire Hospital; Recruiting

Sheffield, South Yorkshire, United Kingdom, S10 2JF

Contact: Luke Barron, MSc 0114 2711899 luke.barron@sth.nhs.uk

Principal Investigator: Mark McAlindon, MD

Principal Investigator: Laurence Hookey, MD

Sponsors and Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

Hotel Dieu Hospital

Investigators

• Principal Investigator: Mark McAlindon, MD; Sheffield Teaching Hospitals NHS Foundation Trust

More Information

• Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT03351972 History of Changes
• Other Study ID Numbers: STH20061
• First Posted: November 24, 2017
• Last Update Posted: April 4, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The study has been set-up and designed to ensure no IPD is shared

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Inflammatory Bowel Diseases; Celiac Disease; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Malabsorption Syndromes; Metabolic Diseases