Lynch Syndrome
Conditions
Keywords
Surveillance, Colorectal cancer, Colonoscopy, Adenoma, Chromoendoscopy
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).
Interventions
OTHERHigh-definition white-light endoscopy
The intervention is do not perform chromoendoscopy
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | one year | Adenoma detection rate is defined as the proportion of patients with at least one adenoma in each arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean number per patient of total polyps | one year | — |
| Mean number per patient of total serrated lesions | one year | — |
| Polyp detection rate | one year | — |
| 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 |
| 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 |
| Serrated lesions detection rate | one year | — |
Countries
Spain
Outcome results
None listed