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

Not Applicable

Completed

• Conditions: Lynch Syndrome
• Interventions: Other: High-definition white-light endoscopy

• 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).

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Primary Completion: 2017-12
• Study Completion: 2017-12-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-definition white-light endoscopy	High-definition white-light endoscopy	High-definition white-light endoscopy without indigo carmine instilation

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 number per patient of total polyps	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
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