EndoLynch: High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome.
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | María Pellisé. MD. PhD. | Barcelona | Spain | 08036 |
Sponsors and Collaborators
- Hospital Clinic of Barcelona
- Fundacion Clinic per a la Recerca Biomédica
Investigators
- Principal Investigator: María Pellisé, MD. PhD., Hospital Clinic of Barcelona
Study Documents (Full-Text)
None provided.More Information
Publications
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- HCB/2016/0440