Clarification effect of l-menthol sprayed onto the early gastric cancer during laser endoscopy

JRCT ID: jRCTs021200027

Registered date:12/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: early gastric cancer
• Date of first enrollment: 06/01/2021
• Target sample size: 65
• Study type: Interventional
• Intervention(s): L-menthol is directly endoscopically applied to early gastric cancer.

Outcome(s)

• Primary Outcome: Proportion of lesions where the color difference between EGC and surrounding mucosa in LCI is 5 or more.

Secondary Outcome

1) Proportion of lesions with a color difference of 5 or more between EGC and surrounding mucosa in WLI and BLI.
2) Median color difference between EGC and surrounding mucosa (LCI, WLI, BLI)
3) Proportion of lesions with increased color difference after l-menthol spraying (LCI, WLI, BLI).
4) Proportion of lesions in which the lesions became easy to see after l-menthol spraying in the subjective judgment of the doctor (scoring).

Key inclusion & exclusion criteria

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

Include criteria

1) Patients who provide written informed consent to participate in the research.
2) Men and women who are 20 years of age or older when consent is obtained.
3) Patients are histologically diagnosed as a gastric cancer.
4) EGC lesion has any of the following.
(1) Macroscopic intramucosal cancer (cTIa) of 3 cm or less, differentiated cancer without ulceration (UL0)
(2) Macroscopic intramucosal cancer (cTIa) of 3 cm or less, differentiated cancer, with ulceration (UL1)
(3) Macroscopic intramucosal cancer (cTIa) of 2 cm or less, undifferentiated cancer without ulceration (UL0).

Exclude criteria

1) A lesion that does not fit in one visual field of an endoscopic image.
2) Lesions on the cardia or pylorus.
3) Easy bleeding lesion.
4) Patients with a history of hypersensitivity to l-menthol.
5) Patients who have been judged by the main reseacher to be inappropriate for inclusion in the study

Related Information

• Primary Sponsor: Hikichi Takuto