Endocuff for Surveillance of Serrated Polyposis Syndrome

NCT02592603 | Completed

• 1 other identifier: HCB/2015/0803
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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

Conditions

Polyposis

Keywords

Serrated lesions; Surveillance; Colorectal cancer; Endocuff; Sessile serrated adenoma; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Number of serrated lesions >=5mm

  Number of serrated lesions \>=5mm detected in each arm

  one year

Secondary Outcomes (11)

• Number of total polyps

  one year

• Number of serrated lesions >=10mm

  one year

• Number of serrated lesions with displasia

  one year

• Number of adenomas

  one year

• Number of advanced adenomas

  one year

Study Arms (2)

Endocuff-assisted Colonoscopy

ACTIVE COMPARATOR

Endocuff-assisted Colonoscopy with the ARC Endocuff-vision® attached at the distal tip of the scope.

Device: Endocuff-assisted Colonoscopy

Standard Colonoscopy

NO INTERVENTION

Standard Colonoscopy without any additional device

Interventions

Endocuff-assisted Colonoscopy DEVICE

Colonic examination with Endocuff-assisted Colonoscopy

Also known as: ECC

Endocuff-assisted Colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with diagnosis of Serrated Polyposis Syndrome undergoing surveillance colonoscopies after clearance of all lesions \>=5mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Fundacion Clinic per a la Recerca Biomédica: collaborator

Study Sites (1)

María Pellisé. MD. PhD.

Barcelona, 08036, Spain

Location

Related Publications (5)

• 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.

  PMID: 26264224 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.

  PMID: 24921209 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.

  PMID: 25470133 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.

  PMID: 26171436 BACKGROUND

• 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.

  PMID: 31174224 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• María Pellisé, MD. PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD. Consultant

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: October 30, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

ES (1)