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Completed

NCT Number: NCT02951390

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

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.

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Key information

Conditions

Lynch Syndrome Adenoma Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Rectal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

María Pellisé. MD. PhD.

Barcelona, 08036, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

High-definition white-light endoscopy

Other

The intervention is do not perform chromoendoscopy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

Registry information

Official study title

High Definition White-Light Colonoscopy Versus Chromoendoscopy for Surveillance of Lynch Syndrome. A Prospective, Multicenter and Randomized Study

Acronym: EndoLynch

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Feb 26, 2018

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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