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GEL study

The Efficacy and Safety of Gel Immersion Endoscopic Mucosal Resection for 15-19mm Non-pedunculated Colorectal Neoplasms

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042240052
Enrollment
60
Registered
2024-06-26
Start date
2024-08-06
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

Non-pedunculated colorectal neoplasms

Interventions

Excise non-pedunculated colorectal neoplasms with gel

Sponsors

Hotta Kinichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Non-pedunculated colorectal neoplasms, size 15-19 mm in endoscopic image (2) Patients who are at least 20 years old at the time of obtaining consent (3) Patients with provided written informed consent

Exclusion criteria

Exclusion criteria: (1) Patients with a recurrent lesion. (2) Lesions near the diverticulum or appendiceal orifice. (3) Submucosal invasive cancer. (4) Lesions endoscopically diagnosed as serrated lesion origin. (5) Patients with inflammatory bowel disease or colorectal polyposis. (6) Patients with coagulation dysfunctions. (7) Patients with severe infectious disease. (8) Patients on dialysis. (9) Patients who cannot discontinue antithrombotic agents based on the guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. (10) Patients with hypersensitivity to Viscoclear. (11) Other cases determined to be unfit for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
En bloc resection rate

Secondary

MeasureTime frame
(1) R0 resection rate (2) Procedure time (3) Adverse events rate (4) Rate of complete GIEMR (5) Amount of gel (6) Rate of Including submucosal tissue (7) Visibility evaluation (4-level rating on a scale)

Contacts

Public ContactKinichi Hotta

Shizuoka Cancer Center

k.hotta@scchr.jp+81-55-989-5222

Outcome results

None listed

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