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High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome. (EndoLynch)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951390
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
María Pellisé, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE October 28, 2016
First Posted Date  ICMJE November 1, 2016
Last Update Posted Date February 26, 2018
Study Start Date  ICMJE July 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
Adenoma detection rate [ Time Frame: one year ]
Adenoma detection rate is defined as the proportion of patients with at least one adenoma in each arm
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2016)
  • Adenoma detection rate [ Time Frame: one year ]
    the proportion of patients with at least one adenoma in each group
  • Mean of adenomas per patient [ Time Frame: one year ]
    the total number of adenomas detected in each group (HD-WLE or HD-CE) divided by the number of colonoscopies in each group
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
  • Mean of adenomas per patient [ Time Frame: one year ]
    the total number of adenomas detected in each group (HD-WLE or HD-CE) divided by the number of colonoscopies in each group
  • Mean number per patient of total polyps [ Time Frame: one year ]
  • Mean number per patient of total serrated lesions [ Time Frame: one year ]
  • Polyp detection rate [ Time Frame: one year ]
  • Serrated lesions detection rate [ Time Frame: one year ]
  • 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
  • Total procedure time [ Time Frame: 30 minutes ]
    Starting with endoscope insertion and withdrawal time including therapeutic interventions
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2016)
  • Mean number per patient of total polyps [ Time Frame: one year ]
  • Mean number per patient of total serrated lesions [ Time Frame: one year ]
  • Polyp detection rate [ Time Frame: one year ]
  • Serrated lesions detection rate [ Time Frame: one year ]
  • 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
  • Total procedure time [ Time Frame: 30 minutes ]
    Starting with endoscope insertion and withdrawal time including therapeutic interventions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome.
Official Title  ICMJE High Definition White-Light Colonoscopy Versus Chromoendoscopy for Surveillance of Lynch Syndrome. A Prospective, Multicenter and Randomized Study
Brief Summary Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which might occur despite a regular follow-up. Despite low evidence, high-definition technology (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection rate in patients with Lynch syndrome.
Detailed Description

The investigators will conduct a prospective multicenter randomized non-inferiority study. Eligible patients will be those with Lynch syndrome (known germline mutation in mismatch repair genes) who undergo surveillance colonoscopies. Patients will be sequentially assigned in a 1:1 ratio to HD-WLE or HD-CE. The method of stratified randomization based on partial colectomy history will be used to avoid proportion imbalance between groups. Participant centers must have an organized high-risk of CRC clinic and endoscopic unit provided with HD technology. Endoscopists must have a documented high adenoma detection rate and experience in performing CE in patients with high-risk conditions of CRC.

The principal aim is to compare the adenoma detection rate with WLE vs CE. Principal outcome measures will be: 1) adenoma detection rate, defined as the proportion of patients with at least one adenoma in each arm; 2) number of adenomas per patient, defined as the total number of detected adenomas in each arm (HD-WLE or HD-CE) divided by the number of colonoscopies in each arm.

The sample size calculation was determined for a non-inferiority study. Assuming an ADR of 28% with conventional chromoendoscopy in patients with Lynch syndrome, a 15% non-inferiority margin, a one-sided significance level of 0.05 powered at 80% and a 10% of drop-off. Based on these assumptions, it was determined that 122 patients were required for each arm (a total of 244).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Lynch Syndrome
Intervention  ICMJE Other: High-definition white-light endoscopy
The intervention is do not perform chromoendoscopy
Study Arms  ICMJE
  • Active Comparator: High-definition white-light endoscopy
    High-definition white-light endoscopy without indigo carmine instilation
    Intervention: Other: High-definition white-light endoscopy
  • No Intervention: High-definition chromoendoscopy
    High-definition indigo-carmine chromoendoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2018)
280
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2016)
244
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with proven pathologic germline mutation in one of the mismatch-repair (MMR) gene (MLH1, MSH2, MSH6, PMS2 or Epcam) who will undergo surveillance colonoscopy

Exclusion Criteria:

  • Patients with total colectomy
  • Concomitant inflammatory bowel disease
  • Inadequate bowel preparation (Boston scale <2 in any colonic segment)
  • Incomplete procedure (without intubation of cecum or ileo-colonic anastomosis)
  • Previous colonoscopy in less than one year
  • Inability to sign informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02951390
Other Study ID Numbers  ICMJE HCB/2016/0440
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party María Pellisé, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE Fundacion Clinic per a la Recerca Biomédica
Investigators  ICMJE
Principal Investigator: María Pellisé, MD. PhD. Hospital Clinic of Barcelona
PRS Account Hospital Clinic of Barcelona
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP