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The Assessment of Duodenal and Small Bowel Polyps in Patients with Familial Adenomatous Polyposis

The Assessment of Duodenal and Small Bowel Polyps in Patients with Familial Adenomatous Polyposis using Capsule Endoscopy and other imaging techniques

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12608000616370
Enrollment
20
Registered
2008-12-08
Start date
2002-03-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To describe the prevalence of cancerous growths in the small bowel as assessed by capsule endoscopy in a group of patients previously diagnosed with Familial Adenomatous Polyposis (FAP). These patients are known to have previously identified cancerous growths and this study aims to compare the findings of capsule endoscopy to correlate this with the findings by other investigative techniques. These techniques are abdominal Magnetic Resonance Imaging (MRI) scanning, barium follow through examination(SBFT), and gastrointestinal side-viewing endoscopy.

Interventions

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 Throu

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.

Sponsors

The Royal Melbourne Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 31, 2026