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

Effectiveness of a Tapered Tip Hood with an Air Bubble Outlet for Underwater Endoscopic Submucosal Dissection for Colorectal Neoplasms: A Prospective Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032210450

Enrollment

Registered

2021-11-25

Start date

2021-11-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early colorectal cancer, Colorectal neuroendocrine tumor Underwater endoscopic submucosal dissection

Interventions

Underwater endoscopic submucosal dissection using a tapered tip hood with an air bubble outlet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Rate of hood-use completion	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactMitsuru Nagata

Department of Endoscopy, Shonan Fujisawa Tokushukai Hospital

mitsuru10jp@yahoo.co.jp+81-466-35-1177

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026