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| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocuff-assisted Colonoscopy | Active Comparator | Endocuff-assisted Colonoscopy with the ARC Endocuff-vision® attached at the distal tip of the scope. |
|
| Standard Colonoscopy | No Intervention | Standard Colonoscopy without any additional device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocuff-assisted Colonoscopy | Device | Colonic examination with Endocuff-assisted Colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of serrated lesions >=5mm | Number of serrated lesions >=5mm detected in each arm | one year |
| 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 |
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Inclusion Criteria:
-Adults with diagnosis of Serrated Polyposis Syndrome undergoing surveillance colonoscopies after clearance of all lesions >=5mm
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa Pellisé, MD. PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MarÃa Pellisé. MD. PhD. | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26264224 | Background | Carballal S, Rodriguez-Alcalde D, Moreira L, Hernandez L, Rodriguez L, Rodriguez-Moranta F, Gonzalo V, Bujanda L, Bessa X, Poves C, Cubiella J, Castro I, Gonzalez M, Moya E, Oquinena S, Clofent J, Quintero E, Esteban P, Pinol V, Fernandez FJ, Jover R, Cid L, Lopez-Ceron M, Cuatrecasas M, Lopez-Vicente J, Leoz ML, Rivero-Sanchez L, Castells A, Pellise M, Balaguer F; Gastrointestinal Oncology Group of the Spanish Gastroenterological Association. Colorectal cancer risk factors in patients with serrated polyposis syndrome: a large multicentre study. Gut. 2016 Nov;65(11):1829-1837. doi: 10.1136/gutjnl-2015-309647. Epub 2015 Aug 11. | |
| 24921209 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 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 |
| Background |
| Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166. |
| 25470133 | Background | Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014. |
| 26171436 | Background | Sawatzki M, Meyenberger C, Marbet UA, Haarer J, Frei R. Prospective Swiss pilot study of Endocuff-assisted colonoscopy in a screening population. Endosc Int Open. 2015 Jun;3(3):E236-9. doi: 10.1055/s-0034-1391418. Epub 2015 Feb 27. |
| 31174224 | Derived | Rivero-Sanchez L, Lopez Vicente J, Hernandez Villalba L, Puig I, Arnau-Collell C, Moreno L, Diaz M, Rodriguez de Miguel C, Ocana T, Moreira L, Cuatrecasas M, Carballal S, Sanchez A, Ortiz O, Llach J, Balaguer F, Pellise M; EndoCAR group from the Spanish Gastroenterology Association and the Spanish Society of Digestive Endoscopy. Endocuff-assisted colonoscopy for surveillance of serrated polyposis syndrome: a multicenter randomized controlled trial. Endoscopy. 2019 Jul;51(7):637-645. doi: 10.1055/a-0925-4956. Epub 2019 Jun 7. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |