A randomized controlled trial comparing conventional ESD versus multi-traction ESD for gastric lesions in porcine mode

UMIN ID: UMIN000045461

Registered date:15/09/2021

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: gastric lesions
• Date of first enrollment: 2021/09/15
• Target sample size: 48
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Standard treatment group (Group A): conventional ESD
Study treatment group (Group B): Multi traction ESD (MT-ESD)

Outcome(s)

• Primary Outcome: ESD procedure time
• Secondary Outcome: Time and speed of mucosal incision and submucosal dissection, arrangement time for traction, en boc/complete resection rate, the volume of submucosal injection, operator change, the number of traction devices and clips, predictive factors associated with ESD difficulties

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Lesions contiguous to the pylorus or fossa

Related Information

• Primary Sponsor: Kyushu University
• Source(s) of Monetary Support: Kyushu University