Tapered Tip Hood with an Air Bubble Outlet in Underwater Colorectal ESD: A Prospective Study

JRCT ID: jRCTs032210450

Registered date:25/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Early colorectal cancer, Colorectal neuroendocrine tumor
• Date of first enrollment: 25/11/2021
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Underwater endoscopic submucosal dissection using a tapered tip hood with an air bubble outlet

Outcome(s)

• Primary Outcome: Rate of hood-use completion
• Secondary Outcome: Rate of completion of underwater endoscopic submucosal dissection, Rate of completion of underwater endoscopic submucosal dissection with a hood, Rate of lesion access, Rate of hood breakage, Dissection speed, Procedure time, Rate of en bloc resection, Rate of complete en bloc resection, Rate of mucosal damage by air bubble outlet, Area of air bubble outlet (mean), Number of air bubbles discharged, Air bubble discharge time (total), air bubble discharge time (mean), Rate of intraoperative perforation, Rate of delayed perforation, Rate of postoperative bleeding

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 94age old
• Gender: Both

Include criteria

1) Patients with preoperative endoscopically or pathologically diagnosed (or suspected) early colorectal cancer with a maximum diameter 2 cm or more or colorectal neuroendocrine tumor with a maximum diameter of 5 mm to 1 cm
2) Patients who provided written consent for undergoing endoscopic submucosal dissection before surgery
3) Patients who provided written consent to participate in this study after receiving sufficient explanation
4) Patients aged between 20 and 94 years at the date of study enrollment
5) Patients with an Eastern Cooperative Oncology Group performance status ranging from 0 to 2

Exclude criteria

1) Patients suspected of having colorectal cancers with deep submucosal invasion (submucosal invasion depth 1,000 micrometer or more)
2) Pregnant patients or patients with the possibility of pregnancy
3) Lactating patients
4) Patients who have previously participated in this study
5) Patients disqualified from this study based on the principal investigator's judgment

Related Information

• Primary Sponsor: Nagata Mitsuru