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

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

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Kathleen Goodrick, BN; Email: kathleen.goodrick@health.nsw.gov.au
• Study Contact Backup: Name: Michael J Bourke, MBBS; Phone Number: 88905555; Email: michael@citywestgastro.com.au

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Endoscopy Unit
      • Contact: Kathleen Goodrick, BN; Phone Number: 88905555; Email: kathleen.goodrick@health.nsw.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed Familial Adenomatous Polyposis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
FAP; FAP patients with duodenal adenomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of serious and non-serious adverse events	bleeding risk; adenoma recurrence	Three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of endoscopic procedure		Three years
Perforation (peri-procedure and delayed)		Three years
Pain post procedure	Measured with 0 - 10 scale	Three years
Hospital readmission		Three years
Change in Spigelman stage		Three years

Collaborators and Investigators

• Sponsor: Western Sydney Local Health District

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): October 10, 2028

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Cold snare polypectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Syndromes, Hereditary; Adenomatous Polyps; Intestinal Polyposis; Nasopharyngeal Neoplasms; Colorectal Neoplasms; Adenoma; Adenomatous Polyposis Coli
• Other Study ID Numbers: HREC/17/WMEAD/20(5002)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No