Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients

Capsule Endoscopy Clinical Trial

— PREP-CE  

Official title:

SMALL BOWEL CLEANSING FOR CAPSULE ENDOSCOPY IN PEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED SINGLE-BLINDED STUDY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01783782
• Other study ID #: CLEANSING FOR PED-CE
• Status: Recruiting
• Phase: Phase 4
• First received: February 1, 2013
• Last updated: February 4, 2013
• Start date: November 2005
• Est. completion date: September 2013

Study information

• Verified date: November 2005
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary aim of this prospective, randomized and controlled study was to evaluate the effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population. The secondary endpoints were to evaluate the safety and the effects of preparation on diagnostic yield of CE.

Description:

Capsule endoscopy (CE) is a well-known, non-invasive, diagnostic tool to evaluate small bowel diseases in adults and children. Unfortunately, because CE does not have functions which allow suctioning of fluid or washing the small bowel mucosa during the examination, its diagnostic yield can be limited by presence of debris, biliary secretion, bubbles and blood in the gut lumen that may hide relevant findings especially in the distal small bowel. In addition, CE sometimes fails to reach the cecum within the battery life of the capsule, resulting in a failure to visualize the distal small intestine. However, in children this problem is less frequent for the increased intestinal motility, which reduces the transit time of the capsule.

It was believed that cleaning the small intestine prior to examination would improve mucosal visibility during the endoscopy and, as a result, the diagnostic yield of the technique. Therefore, proposals were put forward based on preparations for other types of explorations, such as colonoscopies (2).

Some authors have already studied in adults the effect of bowel preparation on small-bowel visualization using different agents; the results of the published series are contradictory. To date, while there is evidence for a benefit from bowel preparation for CE, there is so far no consensus on an optimal preparation regimen. In addition, in children there are not studies on this topic. Therefore, overnight fasting before the examination still remains the proposed preparation for capsule endoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective Small Bowel capsule endoscopy in our Institution between 2 and 18 years of age were recruited for this study.

Exclusion Criteria:

• intestinal obstruction,

• suspicious impaired intestinal motility,

• history of gastrointestinal surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Capsule Endoscopy

Intervention

Behavioral:
• DIET
clear liquid diet for 12 hours on the day before CE, followed by an overnight fast

Drug:
• polyethylene glycol 4000 solution with simethicon
patients received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of PEG solution the evening before the examination, followed always by an overnight fast
• simethicon
Patients received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion

Locations

Country	Name	City	State
Italy	Departments of Pediatrics, Sapienza - University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Preparation efficacy was evaluated by the blinded endoscopist according to a visibility score.; There is no standardized or validated scoring system for the quality of small-bowel cleanliness. The visibility of the mucosal surface was assessed as the percentage of visualized bowel surface area as follows: 1: < 25%; 2: 25%-49%; 3: 50%-74%; 4: 75%-89%; 5: > 90%.	During the performance of capsule endoscopy	No
Secondary	Efficacy	the number of positive findings and the overall diagnostic yield.; A positive finding was defined as the presence of a visible finding, whether incidental or clinically relevant. A positive yield at CE was assumed if the visible finding was considered relevant to the indication for CE. Where appropriate, this was confirmed by further evaluation (repeated upper-GI or lower-GI endoscopy, single-balloon enteroscopy (SBE), laparotomy, or cross-sectional imaging).	during the reading capsule endoscopy	No
Secondary	Safety	Adverse events were assessed on the day of capsule endoscopy by direct questioning and by telephone interview 48-96 hours after capsule endoscopy.	4 days	Yes
Secondary	clinical tolerabiity	Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort.; All patients were tested with a questionnaire, based on a numerical scale between 0 and 10 (with 10 being no burden at all and 0 indicating an intolerable procedure), about the impact of the bowel preparation (Van Tuyl Endoscopy 2007) and their level of satisfaction.	On the morning of colonoscopy, immediately before the procedure	Yes