PolypsSPIDANCT02470416
Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas
A study testing Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD in people with Polyps, run by Western Sydney Local Health District at 1 site in Australia.
Trial summary
Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas by performing small bowel capsule endoscopy and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polyps
- What is being tested?
- Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2015to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cases - Patients who were diagnosed with or underwent resection of a duodenal adenoma/ampulloma at Westmead hospital between the years 2005-2014.
- Controls - Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Case Control Study on the Prevalence of Small Bowel and Colonic Polyps in Patients With Duodenal Adenomas/Ampullomas Who do Not Have Familial Adenomatous Polyposis (FAP) or Peutz Jeghers Syndrom (PJS).
Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas by performing small bowel capsule endoscopy and comparing the results to those acquired from a control cohort undergoing VCE for accepted indication at our centre.
Read the detailed description
Investigation for suspected SB tumors is an acceptable indication for VCE. SB polyps occur frequently in patients with FAP/PJS and in patients with FAP, they are significantly more common in patients with Duodenal/Ampullary polyps. Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps.
The primary hypothesis is that patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas have a higher prevalence of small bowel polyps compared with patients undergoing VCE for various indications who have not had a duodenal polyp diagnosed or removed.
Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital will receive VCE examination. Control population will consist of age matched controls having VCE for OGIB/IDA at Westmead hospital. Patients will be required to have had a documented colonoscopy within the previous three years. If colonoscopy was not performed within this time frame, the patient will have a colonoscopy as part of the study protocol.
- Conditions
- Polyps
- Being tested
- Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD
- Keywords
- duodenal, ampulla
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTDDevice
Cases and controls will have a standard VCE procedure at our institution.
| Study group | Role | What they receive |
|---|---|---|
| Case | Active comparator | Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital Receives: Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD |
| Control | Active comparator | Age matched controls having VCE for OGIB/IDA at Westmead hospital. Receives: Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas
Measured: 24 months
Secondary outcomes (1)
Number of participants with presence and prevalence of colonic polyps
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2018
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Collaborators
- Westmead Hospital
- Responsible party
- Principal investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael Bourke, MBBS, FRACP, Principal investigator, WSLHD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470416
- Sponsor's protocol ID
- HREC/14/WMEAD/226(4028)
- Acronym
- SPIDA
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2015
- Last updated
- 29 Jun 2023
- Results posted
- No
Publications
Awadie H, Klein A, Tate D, Jideh B, Bar-Yishai I, Goodrick K, Ahlenstiel G, Bourke MJ. The prevalence of small-bowel polyps on video capsule endoscopy in patients with sporadic duodenal or ampullary adenomas. Gastrointest Endosc. 2021 Mar;93(3):630-636. doi: 10.1016/j.gie.2020.07.029. Epub 2020 Jul 24.
PubMed 32717365
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case Control Study on the Prevalence of Small Bowel and Colonic Polyps in Patients With Duodenal Adenomas/Ampullomas Who do Not Have Familial Adenomatous Polyposis (FAP) or Peutz Jeghers Syndrom (PJS).
- ClinicalTrials.gov ID
- NCT02470416
- Acronym / sponsor ID
- SPIDA / HREC/14/WMEAD/226(4028)
- Conditions
- Polyps
- Keywords
- duodenal, ampulla
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Collaborators
- Westmead Hospital
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas by performing small bowel capsule endoscopy and comparing the results to those acquired from a control cohort undergoing VCE for accepted indication at our centre.
Detailed description
Investigation for suspected SB tumors is an acceptable indication for VCE. SB polyps occur frequently in patients with FAP/PJS and in patients with FAP, they are significantly more common in patients with Duodenal/Ampullary polyps. Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps.
The primary hypothesis is that patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas have a higher prevalence of small bowel polyps compared with patients undergoing VCE for various indications who have not had a duodenal polyp diagnosed or removed.
Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital will receive VCE examination. Control population will consist of age matched controls having VCE for OGIB/IDA at Westmead hospital. Patients will be required to have had a documented colonoscopy within the previous three years. If colonoscopy was not performed within this time frame, the patient will have a colonoscopy as part of the study protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Active comparator | Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTDPatients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital |
| Control | Active comparator | Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTDAge matched controls having VCE for OGIB/IDA at Westmead hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Cases - Patients who were diagnosed with or underwent resection of a duodenal adenoma/ampulloma at Westmead hospital between the years 2005-2014.
- Controls - Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTDCases and controls will have a standard VCE procedure at our institution. | Device | Case, Control |
Primary outcome
Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas
Time frame: 24 months
1 secondary outcome
Number of participants with presence and prevalence of colonic polyps
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 32717365Awadie H, Klein A, Tate D, Jideh B, Bar-Yishai I, Goodrick K, Ahlenstiel G, Bourke MJ. The prevalence of small-bowel polyps on video capsule endoscopy in patients with sporadic duodenal or ampullary adenomas. Gastrointest Endosc. 2021 Mar;93(3):630-636. doi: 10.1016/j.gie.2020.07.029. Epub 2020 Jul 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bourke, MBBS, FRACP principal investigator
WSLHD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD in people with Polyps, run by Western Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02470416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.