Comparision of the border of colorectal adenomatous lesions between un derwater and under-gel

JRCT ID: jRCTs062220033

Registered date:10/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal adenoma
• Date of first enrollment: 24/07/2022
• Target sample size: 72
• Study type: Interventional

Intervention(s)

Endoscopic observation should be performed in Underwater and Under-gel according to the preliminary
allocation.
After imaging, aspirate saline or Viscoclear as much as possible, and perform the next endoscopic
observation with Underwater and Under-gel according to the prior allocation.
Afterwards, mark two points on the right and left sides of the lesion border, and then perform UEMR
or Under-gel EMR to resect the lesion.

Outcome(s)

• Primary Outcome: the visibility of tumor borders in underwater and under-gel

Secondary Outcome

(1)the visibility of tumor borders in underwater and under-gel (subjective evaluation in 4 levels)
(2)color differences by bowel preparation
(3)Pathological evaluation and adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with non-pedunculated adenomatous colorectal lesions of 6 mm or more but less than 20 mm on colonoscopy performed within the past 18 months
2) The most proximal lesion, if there are multiple lesions between 6mm and 20mm
3)Patients who are 20 years of age or older at the time of obtaining consent.
4)Patients who have obtained written consent of t heir own free will with full understanding after receiving
sufficient explanation for participation in this study.

Exclude criteria

1)Patients with suspected invasive cancer (submu cosa or deeper)
2)Patients with Inflammatory Bowel Disease (IBD)
3)Patients who cannot undergo bowel
4) Patients with a history of hypersensitivity to any ingredient of Viscoclear
5) Patients deemed ineligible by the researchers

Related Information

• Primary Sponsor: Yamasaki Yasushi
• Source(s) of Monetary Support: FUJIFILM Cor.