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

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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

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.

Condition or disease Intervention/treatment Phase
Lynch Syndrome Other: High-definition white-light endoscopy Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: High Definition White-Light Colonoscopy Versus Chromoendoscopy for Surveillance of Lynch Syndrome. A Prospective, Multicenter and Randomized Study
Study Start Date : July 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High-definition white-light endoscopy
High-definition white-light endoscopy without indigo carmine instilation
Other: High-definition white-light endoscopy
The intervention is do not perform chromoendoscopy

No Intervention: High-definition chromoendoscopy
High-definition indigo-carmine chromoendoscopy



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Mean number per patient of total polyps [ Time Frame: one year ]
  3. Mean number per patient of total serrated lesions [ Time Frame: one year ]
  4. Polyp detection rate [ Time Frame: one year ]
  5. Serrated lesions detection rate [ Time Frame: one year ]
  6. 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

  7. Total procedure time [ Time Frame: 30 minutes ]
    Starting with endoscope insertion and withdrawal time including therapeutic interventions



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951390


Locations
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Spain
María Pellisé. MD. PhD.
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fundacion Clinic per a la Recerca Biomédica
Investigators
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Principal Investigator: María Pellisé, MD. PhD. Hospital Clinic of Barcelona

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: María Pellisé, MD. PhD. Consultant, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02951390     History of Changes
Other Study ID Numbers: HCB/2016/0440
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by María Pellisé, Hospital Clinic of Barcelona:
Surveillance
Colorectal cancer
Colonoscopy
Adenoma
Chromoendoscopy
Additional relevant MeSH terms:
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Colorectal Neoplasms, Hereditary Nonpolyposis
Syndrome
Disease
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases