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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

Tracking Information
First Submitted Date March 13, 2018
First Posted Date March 20, 2018
Last Update Posted Date July 5, 2019
Actual Study Start Date October 10, 2017
Estimated Primary Completion Date October 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2018)
Number of serious and non-serious adverse events [ Time Frame: Three years ]
  • bleeding risk
  • adenoma recurrence
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 28, 2018)
  • Duration of endoscopic procedure [ Time Frame: Three years ]
  • Perforation (peri-procedure and delayed) [ Time Frame: Three years ]
  • Pain post procedure [ Time Frame: Three years ]
    Measured with 0 - 10 scale
  • Hospital readmission [ Time Frame: Three years ]
  • Change in Spigelman stage [ Time Frame: Three years ]
Original Secondary Outcome Measures
 (submitted: March 13, 2018)
  • Duration of endoscopic procedure [ Time Frame: Three years ]
  • Perforation (peri-procedure and delayed) [ Time Frame: Three years ]
  • Pain post procedure [ Time Frame: Three years ]
  • Hospital readmission [ Time Frame: Three years ]
  • Change in Spigelman stage [ Time Frame: Three years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Official Title Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
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
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with diagnosed Familial Adenomatous Polyposis
Condition Familial Adenomatous Polyposis
Intervention Not Provided
Study Groups/Cohorts FAP
FAP patients with duodenal adenomas
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 13, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 10, 2020
Estimated Primary Completion Date October 10, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Michael J Bourke, MBBS 88905555 michael@citywestgastro.com.au
Contact: Kathleen Goodrick, BN kathleen.goodrick@health.nsw.gov.au
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03471403
Other Study ID Numbers HREC/17/WMEAD/20(5002)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Professor Michael Bourke, Western Sydney Local Health District
Study Sponsor Western Sydney Local Health District
Collaborators Not Provided
Investigators Not Provided
PRS Account Western Sydney Local Health District
Verification Date July 2019