Efficacy and safety of a novel needle-type knife with through the needle fluid injection compared to a conventional needle-type knife for colorectal ESD

Efficacy and safety of a novel needle-type knife with through the needle fluid injection compared to a conventional needle-type knife for colorectal ESD - Efficacy and Safety of the Tech Knife for Colorectal ESD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052397

Enrollment

270

Registered

2023-10-04

Start date

2023-10-16

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

Colorectal tumor

Interventions

Group A: Tech knife group Group A performs ESD using a Tech knife. Group B: Dual knife J group Group B performs ESD using a Dual knife.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients undergoing endoscopic submucosal dissection (ESD) for colorectal tumor. 2) Patients have been diagnosed with colorectal adenoma or early stage colorectal cancer (including suspected cancer) with suspected submucosal slight invasion larger than 20 mm. 3) Patients are more than 20 years old at the time of registration. 2) PS (ECOG) is either 0 or 1. 3) Written consent has been obtained after sufficient informed consent for participation in this study.

Exclusion criteria

Exclusion criteria: 1) Giant lesions with a tumor diameter of 50 mm or more or more than 3/4 circumference 2) Extension into or proximity to the appendiceal orifice or diverticulum, requiring ESD treatment of the orifice or diverticular area 3) Local recurrence after endoscopic resection or postoperative anastomotic lesions 4) Colorectal cancer with inflammatory bowel disease 5) Familial adenomatous colorectal adenomatosis 6) Patients with infectious diseases requiring systemic treatment 7) Patients with serious comorbidities that make it difficult for them to participate in this study 8) Women of childbearing potential, pregnant, or lactating women 9) Positive COVID19 antigen test or PCR test, etc. in advance. No symptoms are required. 10) Other cases in which participation in this study is deemed inappropriate by the physician in charge

Design outcomes

Primary

Measure	Time frame
Resection time	—

Secondary

Measure	Time frame
Resection speed Number of times the device is inserted and removed Total local injection volume (volume of sodium hyaluronate solution and saline combined) Intraoperative perforation rate	—

Countries

Japan

Contacts

Public ContactYuki Kano

NTT medical center Tokyo Department of Gastrointestinal Endoscopy

snowsmile19870628@gmail.com03-3448-6111

Outcome results

None listed

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