NCT03344289

Brief Summary

The aim of the present study is to compare polyp detection rates of LCI with high-definition white light endoscopy (HD-WLE) in patients with Lynch syndrome in a parallel, international, multicenter, randomized controlled colonoscopy trial

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

November 13, 2017

Last Update Submit

July 13, 2020

Conditions

Lynch SyndromeColonoscopy

Keywords

Linked-color-imagingAdvanced Imaging Techniques

Outcome Measures

Primary Outcomes (1)

  • polyp detection rates

    The aim of the present study is to compare polyp detection rates of LCI with high-definition white light endoscopy (HD-WLE) in patients with Lynch syndrome in a parallel, international, multicenter, randomized controlled colonoscopy trial.

    2 years

Secondary Outcomes (6)

  • mean number of detected polyps

    2 years

  • adenoma detection rate

    2 years

  • mean number of adenomas

    2 years

  • mean number of serrated polyps

    2 years

  • mean duration of procedures

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Linked color imaging

EXPERIMENTAL

When the patient is randomized for LCI, the imaging mode is switched to LCI and colonoscopic inspection will take place during withdrawal of the endoscope

Diagnostic Test: Colonoscopy

High definition white light

ACTIVE COMPARATOR

When the patient is randomized for HD-WLE, the imaging mode is switched to HD-WLE and colonoscopic inspection will take place during withdrawal of the endoscope.

Diagnostic Test: Colonoscopy

Interventions

ColonoscopyDIAGNOSTIC_TEST

Participants will be randomized towards colonoscopy withdrawal with either LCI or HD-WLE

High definition white lightLinked color imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Lynch-syndrome, with a germline mutation in one of the MMR genes (MLH1, MSH2, MSH6, PMS2)
  • Age \>18 years
  • Surveillance colonoscopy for Lynch syndrome.

You may not qualify if:

  • Recent surveillance colonoscopy within 1 year from current exam (e.g. after piecemeal EMR) or patients referred for endoscopic evaluation of known colorectal neoplasia.
  • Colonoscopy planned for the evaluation of symptoms like rectal blood loss, recent change in bowel habits, weight loss or anemia.
  • Patients with a concurrent diagnosis of (serrated) polyposis syndrome or inflammatory bowel disease.
  • Patients who are unwilling or unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Centre

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (1)

  • Houwen BBSL, Hazewinkel Y, Pellise M, Rivero-Sanchez L, Balaguer F, Bisschops R, Tejpar S, Repici A, Ramsoekh D, Jacobs MAJM, Schreuder RM, Kaminski MF, Rupinska M, Bhandari P, van Oijen MGH, Koens L, Bastiaansen BAJ, Tytgat KM, Fockens P, Vleugels JLA, Dekker E. Linked Colour imaging for the detection of polyps in patients with Lynch syndrome: a multicentre, parallel randomised controlled trial. Gut. 2022 Mar;71(3):553-560. doi: 10.1136/gutjnl-2020-323132. Epub 2021 Mar 18.

    PMID: 34086597DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: An international, multicenter, parallel randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Evelien Dekker, MD, PhD

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 17, 2017

Study Start

January 21, 2018

Primary Completion

May 1, 2020

Study Completion

June 9, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

NL(1)