A comparison study between Leaser and LED endoscopy in colonic mucosa

JRCT ID: jRCTs052200073

Registered date:23/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 26/03/2021
• Target sample size: 35
• Study type: Interventional

Intervention(s)

Group A: Observation of the large intestine with a laser endoscope (LASEREO system), followed by sigmoid colon observation with an LED endoscope (ELUXEO system)
Group B: Observation of the large intestine with an LED endoscope (ELUXEO system), followed by sigmoid colon observation with a laser endoscope (LASEREO system)

Outcome(s)

• Primary Outcome: The evaluation of colonic mucosa by LCI classification

Secondary Outcome

1) The evaluation of colonic mucosa by Mayo endscopic subscore (MES)
2) The evaluation of colonic mucosa by Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
3) The evaluation of colonic mucosa by Munsell color system
4) The evaluation of colonic mucosa by L*a*b* color system
5) Appearance of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) The ulcerative colitis (UC) patients with extensive type or left-sided type who was diagnosed using clinical, endoscopic, and histologic findings
2) The UC patients who need the colonoscopy for evaluation of mucosal healing or surveillance for dysplasia or colorectal associated cancer
3) The UC patients with clinical remission status (as defined by Lichitiger index less than 4)
4) Age more than 20 years and less than 80
5) Informed consent was obtained from all enrolled UC patients

Exclude criteria

1) The ulcerative colitis (UC) patients with proctitis type
2) The UC patients with a history of complications on colonoscopy
3) The UC patients who are already undergoing or have undergone chemotherapy or radiation therapy for a known neoplastic disease
4) The UC patients with any of the following complications;
i)Infectious enteritis
ii)Colorectal cancer
5) The UC patients with drug allergies to the pretreatment drug for colonoscopy
6) The UC patients who needs a legal representative because of any difficulties to obtain informed consent
7) The UC patients who are considered to be ineligible by the chief investigator and subinvestigators

Related Information

• Primary Sponsor: Takagi Tomohisa
• Source(s) of Monetary Support: Fujifilm Holdings Corporation