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Familial Adenomatous PolyposisCOPDANCT03471403

Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis

An observational study of Familial Adenomatous Polyposis, run by Western Sydney Local Health District at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to collect prospective observational data regarding patients with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for duodenal adenomas Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Familial Adenomatous Polyposis
How many people
100 participants
Where
1 siteAustralia
Study dates
10 Oct 2017to 10 Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with diagnosed Familial Adenomatous Polyposis

Who may be able to join

  • Patient's diagnosed with a confirmed diagnosis of FAP (genetic testing) and able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
  • Patients already commenced on endoscopic surveillance for FAP.

Who cannot join

  • Patient's with known strictures/stenosis
  • Pregnancy
  • Patients who did not consent to study
  • Bleeding diathesis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael J Bourke, MBBS contact

88905555

michael@citywestgastro.com.au

Australia1 site, 1 recruiting
  • Westmead Endoscopy Unit

    Westmead, New South Wales, 2145

    Clarence Kerrison, MBBS, 88905555, clarence.kerrison@health.nsw.gov.au

    Recruiting

Other trials in Australia

About this study

The purpose of this study is to collect prospective observational data regarding patients with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for duodenal adenomas

Read the detailed description

Familial adenomatous polyposis (FAP) is a autosomal dominant disorder, secondary to a germ-line mutation in the tumour suppressor gene and characterised by multiple colorectal polyps (>100). Typically colorectal adenomas develop in the second and third decade of life. As a result these patients require an endoscopic colonic surveillance program, especially for at-risk family members, which usually begins in the 2nd decade of life starting with annual flexible sigmoidoscopies. The lifetime risk of colorectal cancer (CRC) is 100 percent, if left untreated and patient usually develop CRC in the 4th-5th decade of life. The patient's thus usually progress to a total colectomy.

FAP is also associated with adenomas in the upper gastrointestinal tract and is in nearly 90% of patients with FAP by age 70.Upper gastrointestinal tract screening with gastroscopies commences usually from 25-30 years of age. Usually a duodenoscopy is performed simultaneously to assess for ampullary adenomas. Although surgical procedures have been shown to be effective and have changed the natural history of colorectal cancer in FAP the management of duodenal adenomatosis remains a challenge. The prevalence of FAP associated duodenal adenomas has led to the development of Spigelman classification which assigns surveillance intervals by dividing patient's into four group based on size, histology and severity of dysplasia on histology7. Local endoscopic therapy options available for duodenal adenomatosis include; snare polypectomy, thermal ablation (using a mono/bipolar current) and laser coagulation each with their own limitation. Endoscopic intervention is usually recommended for Spigelman stage II and III disease.

Duodenal endoscopic mucosal resection (EMR) has been shown to be safe and effective methods in removing flat duodenal adenomas in FAP as observed in small case series. However as with colonic EMR these patient's automatically are placed in a higher risk group with the feared complications of delayed bleeding (per and post procedure) and perforation, with the former being as high as 10-15%. The bleeding risk is especially increased in the duodenum due to the rich vascularity of the sub-mucosal layer.

Cold snare polypectomy (CSP) has been shown to be a safe and effective method for removing diminutive colorectal polyps (<8mm) as compared to conventional polypectomy/endoscopic mucosal resection (EMR).

A small case series published the use of a hybrid technique, for duodenal adenomas, where a submucosal injection is performed underneath the lesion to separate the mucosa from the larger sub-mucosal vessels from which bleeding risk is thought to arise. By then performing cold snare piece-meal polypectomy and avoiding the need for thermal therapy risk of delayed bleeding associated is significantly reduced as compared to conventional EMR.

Isolated case report using CSP in non-ampullary duodenal adenomas have shown this technique to be effective.

No large studies to date have examined the use of this technique for duodenal adenomas.

Keywords
Cold snare polypectomy
Medical subject headings
Adenomatous Polyposis Coli

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03471403
Study groupRoleWhat they receive
FAPFAP patients with duodenal adenomas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of serious and non-serious adverse events

    • bleeding risk
    • adenoma recurrence

    Measured: Three years

Secondary outcomes (5)
  1. Duration of endoscopic procedure

    Measured: Three years

  2. Perforation (peri-procedure and delayed)

    Measured: Three years

  3. Pain post procedure

    Measured with 0 - 10 scale

    Measured: Three years

  4. Hospital readmission

    Measured: Three years

  5. Change in Spigelman stage

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2018
  2. Study start10 Oct 2017
  3. Primary completion10 Oct 2027 (estimated)
  4. Study completion10 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03471403
Sponsor's protocol ID
HREC/17/WMEAD/20(5002)
Acronym
COPDA
Status last verified
Mar 2025
First submitted
13 Mar 2018
Last updated
27 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Familial Adenomatous Polyposis, 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 4 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael J Bourke, MBBS (88905555, michael@citywestgastro.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of serious and non-serious adverse events (time frame: Three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Mar 2025.

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