Endocuff for Surveillance of Serrated Polyposis Syndrome

Study Overview
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Brief Summary
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Serrated Polyposis Syndrome (SPS) is a high-risk condition for colorectal cancer (CRC). SPS patients have a cumulative CRC risk of 1.9% in 5 years despite a strict endoscopic surveillance in specialized centers. Proximal serrated lesions are endoscopically challenging to detect due to their unremarkable morphology. Endocuff is a novel device comprised of a cap with a row of finger-like projections with a unique dynamic shape that help to flatten mucosal folds during withdrawal of the instrument in order to improve detection of lesions. Recent studies have reported an increase of detection rate and mean per patient of adenomas with Endocuff-assisted Colonoscopy compared with Standard Colonoscopy. The purpose of this study is to assess the usefulness of Endocuff-assisted Colonoscopy to detect serrated lesions in SPS patients undergoing surveillance compared to Standard Colonoscopy in a randomized fashion

Detailed Description
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According to own data and similarly to previous published studies, patients diagnosed of Serrated Polyposis Syndrome undergoing annual surveillance after clearance of all serrated lesions ≥ 5mm, have a mean of 5 serrated lesions per patient at follow-up colonoscopies. The study was powered to establish a 25% significant increase in the mean of serrated lesions per patient in the Endocuff-assisted colonoscopy group. Accepting an alpha risk of 0.05, a beta risk of 0.2 and a loss rate of 10% in a bilateral contrast, a sample size of 124 patients (62 in each arm) are required to achieve statistic significance.

Official Title
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Endocuff-assisted vs. Standard Colonoscopy for Surveillance of Serrated Polyposis Syndrome: A Randomized Controlled Trial

Conditions
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Polyposis

Intervention / Treatment
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* Device: Endocuff-assisted Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Adults with diagnosis of Serrated Polyposis Syndrome undergoing surveillance colonoscopies after clearance of all lesions >=5mm Exclusion Criteria: Patients with known strictures Partial or total colonic resection Acute diverticulitis Concomitant inflammatory bowel disease Suspected or proven lower gastrointestinal bleeding Non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure Inability to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endocuff-assisted Colonoscopy<br>Endocuff-assisted Colonoscopy with the ARC Endocuff-vision® attached at the distal tip of the scope. | Device: Endocuff-assisted Colonoscopy<br>* Colonic examination with Endocuff-assisted Colonoscopy<br>* Other names: ECC;|
| No Intervention: Standard Colonoscopy<br>Standard Colonoscopy without any additional device | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serrated lesions >=5mm | Number of serrated lesions >=5mm detected in each arm | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of total polyps | Number of total polyps in each arm | one year | 
| Number of serrated lesions >=10mm | Number of serrated lesions >=10mm detected in each arm | one year | 
| Number of serrated lesions with displasia | Number of serrated lesions with displasia in each arm | one year | 
| Number of adenomas | Number of adenomas in each arm | one year | 
| Number of advanced adenomas | Number of advanced adenomas in each arm | one year | 
| Number of flat lesions | Number of flat lesions in each arm | one year | 
| Number of flat lesions in right colon | Number of flat lesions in right colon in each arm | one year | 
| Withdrawal time | Extubation time from the cecum to scope removal from the anus, with exception of time taken for any therapeutic intervention | 30 minutes | 
| Total procedure time | Starting with endoscope insertion and withdrawal time including therapeutic interventions | 30 minutes | 
| Proportion of major adverse events | Colonic perforation or clinically significant bleeding | Two weeks | 
| Proportion of minor adverse events | Superficial mucosal erosions in the colonic mucosa, abdominal pain and bloating | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serrated lesions, Surveillance, Colorectal cancer, Endocuff, Sessile serrated adenoma, Colonoscopy