Endocuff for Surveillance of Serrated Polyposis Syndrome

Polyposis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592603
• Other study ID #: HCB/2015/0803
• Status: Completed
• Phase: N/A
• First received: October 29, 2015
• Last updated: August 3, 2017
• Start date: October 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Nasopharyngeal Neoplasms
• Polyposis

Intervention

Device:
• Endocuff-assisted Colonoscopy
Colonic examination with Endocuff-assisted Colonoscopy

Locations

Country	Name	City	State
Spain	María Pellisé. MD. PhD.	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Biecker E, Floer M, Heinecke A, Ströbel P, Böhme 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. — View Citation

Carballal S, Rodríguez-Alcalde D, Moreira L, Hernández L, Rodríguez L, Rodríguez-Moranta F, Gonzalo V, Bujanda L, Bessa X, Poves C, Cubiella J, Castro I, González M, Moya E, Oquiñena S, Clofent J, Quintero E, Esteban P, Piñol V, Fernández FJ, Jover R, Cid L, López-Cerón M, Cuatrecasas M, López-Vicente J, Leoz ML, Rivero-Sánchez L, Castells A, Pellisé 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. — View Citation

Floer M, Biecker E, Fitzlaff R, Röming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Ströbel 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serrated lesions >=5mm	Number of serrated lesions >=5mm detected in each arm	one year
Secondary	Number of total polyps	Number of total polyps in each arm	one year
Secondary	Number of serrated lesions >=10mm	Number of serrated lesions >=10mm detected in each arm	one year
Secondary	Number of serrated lesions with displasia	Number of serrated lesions with displasia in each arm	one year
Secondary	Number of adenomas	Number of adenomas in each arm	one year
Secondary	Number of advanced adenomas	Number of advanced adenomas in each arm	one year
Secondary	Number of flat lesions	Number of flat lesions in each arm	one year
Secondary	Number of flat lesions in right colon	Number of flat lesions in right colon in each arm	one year
Secondary	Withdrawal time	Extubation time from the cecum to scope removal from the anus, with exception of time taken for any therapeutic intervention	30 minutes
Secondary	Total procedure time	Starting with endoscope insertion and withdrawal time including therapeutic interventions	30 minutes
Secondary	Proportion of major adverse events	Colonic perforation or clinically significant bleeding	Two weeks
Secondary	Proportion of minor adverse events	Superficial mucosal erosions in the colonic mucosa, abdominal pain and bloating	Two weeks