Polyposis
Conditions
Keywords
Serrated lesions, Surveillance, Colorectal cancer, Endocuff, Sessile serrated adenoma, Colonoscopy
Brief summary
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
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.
Interventions
Colonic examination with Endocuff-assisted Colonoscopy
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of serrated lesions >=5mm | one year | Number of serrated lesions \>=5mm detected in each arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of serrated lesions >=10mm | one year | Number of serrated lesions \>=10mm detected in each arm |
| Number of serrated lesions with displasia | one year | Number of serrated lesions with displasia in each arm |
| Number of adenomas | one year | Number of adenomas in each arm |
| Number of advanced adenomas | one year | Number of advanced adenomas in each arm |
| Number of flat lesions | one year | Number of flat lesions in each arm |
| Number of total polyps | one year | Number of total polyps in each arm |
| Withdrawal time | 30 minutes | Extubation time from the cecum to scope removal from the anus, with exception of time taken for any therapeutic intervention |
| Total procedure time | 30 minutes | Starting with endoscope insertion and withdrawal time including therapeutic interventions |
| Proportion of major adverse events | Two weeks | Colonic perforation or clinically significant bleeding |
| Proportion of minor adverse events | Two weeks | Superficial mucosal erosions in the colonic mucosa, abdominal pain and bloating |
| Number of flat lesions in right colon | one year | Number of flat lesions in right colon in each arm |
Countries
Spain
Outcome results
None listed