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Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis (COPDA)

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ClinicalTrials.gov Identifier: NCT03471403
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

Study Description
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Brief 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

Condition or disease
Familial Adenomatous Polyposis

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : October 10, 2020
Estimated Study Completion Date : October 10, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
FAP
FAP patients with duodenal adenomas


Outcome Measures
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Primary Outcome Measures :
  1. Number of serious and non-serious adverse events [ Time Frame: Three years ]
    • bleeding risk
    • adenoma recurrence


Secondary Outcome Measures :
  1. Duration of endoscopic procedure [ Time Frame: Three years ]
  2. Perforation (peri-procedure and delayed) [ Time Frame: Three years ]
  3. Pain post procedure [ Time Frame: Three years ]
    Measured with 0 - 10 scale

  4. Hospital readmission [ Time Frame: Three years ]
  5. Change in Spigelman stage [ Time Frame: Three years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosed Familial Adenomatous Polyposis
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient's with known strictures/stenosis
  • Pregnancy
  • Patients who did not consent to study
  • Bleeding diathesis
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471403


Contacts
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Contact: Michael J Bourke, MBBS 88905555 michael@citywestgastro.com.au
Contact: Kathleen Goodrick, BN kathleen.goodrick@health.nsw.gov.au

Locations
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Australia, New South Wales
Westmead Endoscopy Unit Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Kathleen Goodrick, BN    88905555    kathleen.goodrick@health.nsw.gov.au   
Sponsors and Collaborators
Western Sydney Local Health District
More Information
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Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT03471403    
Other Study ID Numbers: HREC/17/WMEAD/20(5002)
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Michael Bourke, Western Sydney Local Health District:
Cold snare polypectomy
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn