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Completed

NCT Number: NCT02592603

Endocuff for Surveillance of Serrated Polyposis Syndrome

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

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Key information

Conditions

Polyposis Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

María Pellisé. MD. PhD.

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EndoCuff-assisted colonoscopy

Device

Colonic examination with Endocuff-assisted Colonoscopy

Other names: ECC

Primary outcomes

  1. Number of serrated lesions >=5mm

    Time frame: one year

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

Secondary outcomes

  1. Number of total polyps

    Time frame: one year

    Number of total polyps in each arm

  2. Number of serrated lesions >=10mm

    Time frame: one year

    Number of serrated lesions >=10mm detected in each arm

  3. Number of serrated lesions with displasia

    Time frame: one year

    Number of serrated lesions with displasia in each arm

  4. Number of adenomas

    Time frame: one year

    Number of adenomas in each arm

  5. Number of advanced adenomas

    Time frame: one year

    Number of advanced adenomas in each arm

  6. Number of flat lesions

    Time frame: one year

    Number of flat lesions in each arm

  7. Number of flat lesions in right colon

    Time frame: one year

    Number of flat lesions in right colon in each arm

  8. 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

  9. Total procedure time

    Time frame: 30 minutes

    Starting with endoscope insertion and withdrawal time including therapeutic interventions

  10. Proportion of major adverse events

    Time frame: Two weeks

    Colonic perforation or clinically significant bleeding

  11. Proportion of minor adverse events

    Time frame: Two weeks

    Superficial mucosal erosions in the colonic mucosa, abdominal pain and bloating

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2015
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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