ClinicalTrials.gg
RecruitingNCT03471403COPDAUpdated Mar 27, 2025

Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis

An observational study in Familial Adenomatous Polyposis, sponsored by Western Sydney Local Health District. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Western Sydney Local Health District · Observational

From the registry’s dates

  • Started Oct 2017; still recruiting 9 years 1 month later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Familial Adenomatous Polyposis

Keywords

  • Cold snare polypectomy
03

In context

Adenomatous Polyposis Coli

92 studies on the registry are indexed under Adenomatous Polyposis Coli; 29 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 25 observational studies indexed under Adenomatous Polyposis Coli.

Browse Adenomatous Polyposis Coli studies →

Lead sponsor

Western Sydney Local Health District is the lead sponsor of 36 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with diagnosed Familial Adenomatous Polyposis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient's diagnosed with a confirmed diagnosis of FAP (genetic testing) and able to give 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.

Exclusion criteria

Exclusion Criteria:

  • Patient's with known strictures/stenosis
  • Pregnancy
  • Patients who did not consent to study
  • Bleeding diathesis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • FAP

    FAP patients with duodenal adenomas

06

What researchers measure

Primary outcomes

  1. Number of serious and non-serious adverse events

    * bleeding risk * adenoma recurrence

    Time frame: Three years

Secondary outcomes

  1. Duration of endoscopic procedure

    Time frame: Three years

  2. Perforation (peri-procedure and delayed)

    Time frame: Three years

  3. Pain post procedure

    Measured with 0 - 10 scale

    Time frame: Three years

  4. Hospital readmission

    Time frame: Three years

  5. Change in Spigelman stage

    Time frame: Three years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2017 (actual). Primary completion is estimated for Oct 2027, 120 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2018
First posted
Mar 20, 2018
StartActual
Oct 10, 2017
Primary completionEst.
Oct 10, 2027
CompletionEst.
Oct 10, 2028
Last update
Mar 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03471403
Lead sponsor
Western Sydney Local Health District
Responsible party
Professor Michael Bourke (Director of Gastrointestinal Endoscopy, Western Sydney Local Health District) — Principal investigator
First posted
Mar 20, 2018
Start date
Oct 10, 2017
Primary completion
Oct 10, 2027 (estimated)
Completion
Oct 10, 2028 (estimated)
Last update
Mar 27, 2025

Study contacts

Michael J Bourke, MBBS
Contact
michael@citywestgastro.com.au
88905555

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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