High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome.
- Conditions
- Lynch Syndrome
- Registration Number
- NCT02951390
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adenoma detection rate one year Adenoma detection rate is defined as the proportion of patients with at least one adenoma in each arm
- Secondary Outcome Measures
Name Time Method Mean of adenomas per patient 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 one year Mean number per patient of total serrated lesions one year Polyp detection rate one year Serrated lesions detection rate one year Withdrawal time 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 30 minutes Starting with endoscope insertion and withdrawal time including therapeutic interventions
Trial Locations
- Locations (1)
María Pellisé. MD. PhD.
🇪🇸Barcelona, Spain
María Pellisé. MD. PhD.🇪🇸Barcelona, Spain