Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000616370
Ethics application status
Approved
Date submitted
27/11/2008
Date registered
8/12/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Assessment of Duodenal and Small Bowel Polyps in Patients with Familial Adenomatous Polyposis
Scientific title
The Assessment of Duodenal and Small Bowel Polyps in Patients with Familial Adenomatous Polyposis using Capsule Endoscopy and other imaging techniques
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Familial Adenomatous Polyposis 4041 0
Condition category
Condition code
Oral and Gastrointestinal 4244 4244 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients undergo 4 procedures, within a 6 week timeframe. Each procedure is only performed once per patient.

Initially the patient underwent a Magnetic Resonance Imaging (MRI) of the abdomen performed in the standard manner. The MRI was performed on the fasted patient and scanned using 1 litre of dilute barium as intra luminal contrast. MRI scan involves patient lying on a flatbed in the machine and takes approximately 30 to 60 minutes.

One week after MRI, a barium Small Bowel Follow Through (SBFT) study was performed. Procedure involves (1) Person drinks radio-opaque contrast. (2) X-ray images of abdominal are made. It may take 2 to 4 hours to complete.

The patient proceeded to the Capsule Endoscopy (CE) procedure, four weeks after SBFT. Each patient was required to fast at least 8 hours prior to capsule ingestion, with no additional bowel preparation given to the patients directly prior to their CE. Patient swallows capsule under supervision, and capsule transmits data wirelessly to receiver worn on patient's belt. The patient was allowed to freely move around, but not to leave the facility area in order to ensure medical supervision throughout the transmission period (ie. for a total of 8 hours following from the ingestion of the Capsule).

A gastroscopy using a side-viewing endoscope was done one to two weeks after this in the standard manner. This involves a period of fasting for at least 8 hours prior. At time of procedure, patient lies down and keeps mouth open. A lubricated fibreoptic endoscope is gentle inserted through the mouth down into the Gastrointestinal tract (GIT). Pain medication and a sedative may be administered via IV line during the procedure. Procedure usually lasts 30 to 45 minutes.
Intervention code [1] 3761 0
Not applicable
Comparator / control treatment
Side-viewing gastroscopy. It is a one off procedure.

A gastroscopy using a side-viewing endoscope was done in the standard manner. This involves a period of fasting for at least 8 hours prior. At time of procedure, patient lies down and keeps mouth open. A lubricated fibreoptic endoscope is gentle inserted through the mouth down into the Gastrointestinal tract (GIT). Pain medication and a sedative may be administered via IV line during the procedure. Procedure usually lasts 30 to 45 minutes.
Control group
Active

Outcomes
Primary outcome [1] 5130 0
Number and size of polyps detected in each procedure relative to other procedures. This data is based on interpretation by 2 investigators experienced in their procedure and recording findings on a standardised collection form.

Analysis was essentially comprised of individual data, frequency table and descriptive statistics. Student's t- test / chi square testing were used for a comparison of duodenal polyp numbers and size, and identification of abnormal papillae, as estimated by each method. Analysis of variance was conducted using a General Linear Model and Two-Way ANOVA. Within the duodenum sensitivity and specificity of the Capsule was calculated using the duodenoscopy findings as the "gold standard".
Timepoint [1] 5130 0
The data from each procedure is measured at time of procedure, but comparative analysis is only possible after final procedure has been completed.
Secondary outcome [1] 8633 0
Distribution of polyps detected in each procedure relative to other procedures. This data is based on interpretation by 2 investigators experienced in their procedure and recording findings on a standardised collection form.

Analysis was essentially comprised of individual data, frequency table and descriptive statistics. Student's t- test / chi square testing were used for a comparison of duodenal polyp numbers and size, and identification of abnormal papillae, as estimated by each method. Analysis of variance was conducted using a General Linear Model and Two-Way ANOVA. Within the duodenum sensitivity and specificity of the Capsule was calculated using the duodenoscopy findings as the "gold standard".
Timepoint [1] 8633 0
The data from each procedure is measured at time of procedure, but comparative analysis is only possible after final procedure has been completed.

Eligibility
Key inclusion criteria
previously diagnosed Familial Adenomatous Polyposis (FAP) with duodenal polyps, had a small bowel series/MRI prior to Capsule ingestion and were over the age of 18 years old
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
known or suspected stenosis/obstruction of the small bowel, pregnancy, a swallowing disorder that would preclude the safe ingestion of the capsule, cardiac pacemaker or other implanted electromedical devices

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4219 0
Commercial sector/Industry
Name [1] 4219 0
Given Imaging
Country [1] 4219 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
RMH City Campus
Grattan Steet
Parkville 3050
Country
Australia
Secondary sponsor category [1] 3793 0
None
Name [1] 3793 0
Address [1] 3793 0
Country [1] 3793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6273 0
Human Research Ethics Committee
Ethics committee address [1] 6273 0
Ethics committee country [1] 6273 0
Australia
Date submitted for ethics approval [1] 6273 0
28/03/2002
Approval date [1] 6273 0
17/07/2002
Ethics approval number [1] 6273 0
2002.030

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29176 0
Address 29176 0
Country 29176 0
Phone 29176 0
Fax 29176 0
Email 29176 0
Contact person for public queries
Name 12333 0
Finlay Macrae
Address 12333 0
PO Box 2010
Royal Melbourne Hospital, 3050
Country 12333 0
Australia
Phone 12333 0
+61 3 93427580
Fax 12333 0
Email 12333 0
[email protected]
Contact person for scientific queries
Name 3261 0
Finlay Macrae
Address 3261 0
PO Box 2010
Royal Melbourne Hospital, 3050
Country 3261 0
Australia
Phone 3261 0
+61 3 93427580
Fax 3261 0
Email 3261 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AISurveillance of FAP: a prospective blinded comparison of capsule endoscopy and other GI imaging to detect small bowel polyps2010https://doi.org/10.1186/1897-4287-8-3
N.B. These documents automatically identified may not have been verified by the study sponsor.