Clinical trial NCT02592603: Endocuff for Surveillance of Serrated Polyposis Syndrome
Official title: Endocuff-assisted vs. Standard Colonoscopy for Surveillance of Serrated Polyposis Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyposis
Keywords: Serrated lesions
Surveillance
Colorectal cancer
Endocuff
Sessile serrated adenoma
Colonoscopy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2015-10-30
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of serrated lesions >=5mm
timeFrame: one year
Secondary outcomes:
measure: Number of total polyps
timeFrame: one year
measure: Number of serrated lesions >=10mm
timeFrame: one year
measure: Number of serrated lesions with displasia
timeFrame: one year
measure: Number of adenomas
timeFrame: one year
measure: Number of advanced adenomas
timeFrame: one year
measure: Number of flat lesions
timeFrame: one year
measure: Number of flat lesions in right colon
timeFrame: one year
measure: Withdrawal time
timeFrame: 30 minutes
measure: Total procedure time
timeFrame: 30 minutes
measure: Proportion of major adverse events
timeFrame: Two weeks
measure: Proportion of minor adverse events
timeFrame: Two weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: María Pellisé. MD. PhD.
Study officials:
affiliation: Hospital Clinic of Barcelona
name: María Pellisé, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.