Endocuff for Surveillance of Serrated Polyposis Syndrome

August 3, 2017 updated by: María Pellisé, Hospital Clinic of Barcelona

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • María Pellisé. MD. PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endocuff-assisted Colonoscopy
Endocuff-assisted Colonoscopy with the ARC Endocuff-vision® attached at the distal tip of the scope.
Device: Endocuff-assisted Colonoscopy
Colonic examination with Endocuff-assisted Colonoscopy
Other Names:
  • ECC
No Intervention: Standard Colonoscopy
Standard Colonoscopy without any additional device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of serrated lesions >=5mm
Time Frame: one year
Number of serrated lesions >=5mm detected in each arm
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Withdrawal time
Time Frame: 30 minutes
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
Time Frame: 30 minutes
Starting with endoscope insertion and withdrawal time including therapeutic interventions
30 minutes
Number of total polyps
Time Frame: one year
Number of total polyps in each arm
one year
Number of serrated lesions >=10mm
Time Frame: one year
Number of serrated lesions >=10mm detected in each arm
one year
Number of serrated lesions with displasia
Time Frame: one year
Number of serrated lesions with displasia in each arm
one year
Number of adenomas
Time Frame: one year
Number of adenomas in each arm
one year
Number of advanced adenomas
Time Frame: one year
Number of advanced adenomas in each arm
one year
Number of flat lesions
Time Frame: one year
Number of flat lesions in each arm
one year
Number of flat lesions in right colon
Time Frame: one year
Number of flat lesions in right colon in each arm
one year
Proportion of major adverse events
Time Frame: Two weeks
Colonic perforation or clinically significant bleeding
Two weeks
Proportion of minor adverse events
Time Frame: Two weeks
Superficial mucosal erosions in the colonic mucosa, abdominal pain and bloating
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Fundacion Clinic per a la Recerca Biomédica

Investigators

  • Principal Investigator: María Pellisé, MD. PhD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2015/0803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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