Efficacy of phosphorylated pullulan in endoscopic therapy for early gastric cancer

JRCT ID: jRCT1062240053

Registered date:11/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Early gastric cancer
• Date of first enrollment: 11/09/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): To compare the injection performance of submucosal injection agents (PPL solution vs. hyaluronic acid solution).

Outcome(s)

• Primary Outcome: Injection time of submucosal injection

Secondary Outcome

1. 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

2.PPL usage experience:
Operator evaluation questionnaire (VAS scale)
Ease of treatment
Bubbling during treatment
Caregiver evaluation questionnaire
Ease of injection

3. Gastric ESD procedure results: procedure time, complete en bloc resection rate, incident rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Otsuka Motoyuki