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
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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
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.
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 →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.
Patients with diagnosed Familial Adenomatous Polyposis
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Exclusion Criteria:
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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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FAP patients with duodenal adenomas
Number of serious and non-serious adverse events
* bleeding risk * adenoma recurrence
Time frame: Three years
Duration of endoscopic procedure
Time frame: Three years
Perforation (peri-procedure and delayed)
Time frame: Three years
Pain post procedure
Measured with 0 - 10 scale
Time frame: Three years
Hospital readmission
Time frame: Three years
Change in Spigelman stage
Time frame: Three years
Started Oct 2017 (actual). Primary completion is estimated for Oct 2027, 120 months after the start.
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Western Sydney Local Health District