Efficacy of phosphorylated pullulan in endoscopic therapy for early gastric cancer

Recruiting

• Conditions: Early gastric cancer

• Registration Number: jRCT1062240053

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-11
• Study Start: 2025-01-14
• Last Update Posted: 2025-06-16

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Patients scheduled for gastric ESD for early gastric cancer 2.Patients with early gastric cancer whose lesion diameter is 10-30mm 3.Patients with early gastric cancer whose depth of invasion is assumed to be intramucosal cancer
4.Patients who are able to obtain informed consent to participate in the study of their own free will after receiving sufficient explanation and understanding. 5.Patients aged 18 years or older and younger than 80 years at the time of obtaining consent

Exclusion Criteria

1 Patients scheduled to have two or more lesions of early gastric cancer removed at the same time 2 Patients in whom the incision line during gastric ESD for early gastric cancer is expected to span the cardia or pylorus 3 Patients taking antithrombotic drugs 4 Patients with advanced cancer in other organs 5 Patients using medical devices such as pacemakers 6 Poorly controlled diabetic patients 7 Patients with a history of myocardial infarction 8 Patients with unstable angina 9 Serious liver disease (AST (GOT) or ALT (GPT)100 U or more) or liver cirrhosis patients 10 Patients with severe renal disease (BUN 25 mg/dL or serum creatinine 2.0 mg/dL or higher) 11 Women who are pregnant or may become pregnant 12 lactating women
13 Other patients deemed unsuitable as research subjects by the principal investigator or co-investigator

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Injection time of submucosal injection

Secondary Outcome Measures

Name	Time	Method
Mucosal elevation ability of PPL		- Efficacy rate (rate of achieving en bloc resection with 0-1 additional injections to the same site); - Mucosal elevation form (steep, gentle elevation, no elevation); - Total amount of PPL injections; - Number of additional injections to the same site
PPL usage experience		- Operator evaluation questionnaire (VAS scale); - Ease of treatment; - Bubbling during treatment; - Caregiver evaluation questionnaire; - Ease of injection
Gastric ESD procedure results		- Procedure time; - Complete en bloc resection rate; - Incident rate