GEL study

JRCT ID: jRCT1042240052

Registered date:26/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-pedunculated colorectal neoplasms
• Date of first enrollment: 06/08/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Excise non-pedunculated colorectal neoplasms with gel

Outcome(s)

• Primary Outcome: En bloc resection rate

Secondary Outcome

(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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hotta Kinichi