the efficacy of pullulan phosphate in colorectal EMR

JRCT ID: jRCT1062240071

Registered date:23/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal polyps
• Date of first enrollment: 23/10/2024
• Target sample size: 224
• Study type: Interventional
• Intervention(s): EMR for the target lesion using pullulan phospjate or saline solution according to the allocation. Pathology specimens will be taken evaluate the margins and the depth of submucosal layer. An outpatient visit or telephone call to the treating physician will be made 2-4 weeks after the treatment date to confim the presence of adverse events.

Outcome(s)

• Primary Outcome: Complete resection and no additional submucosal injection rate

Secondary Outcome

i) En bloc resection rate
ii) Adverse events
iii) Resection time
iv) Resection depth
v) Injection volume
vi) Swelling

Key inclusion & exclusion criteria

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

Include criteria

i) non-stalked colorectal polyps between 6 mm and 20 mm in size
ii) 18 years of age or older
iii) Patienst who have been fully informed consent.

Exclude criteria

i) Suspected of invasive cancer
ii) Pedunculated polyps (Type 0-Ip)
iii) Inflammatory Bowel Disease (IBD)
iv) Familial Adenomatous Polyposis (FAP)
v) Patients who have difficulty with withdrawal of medication in accordance with antithrombotic drug guideline
vi) Severe hepatic, renal, or cardiac dysfunction
vii) Pregnant, possibly pregnant, or lactating women
viii) Patients who judged as inappropriate candidate by the chief medical examine

Related Information

• Primary Sponsor: Yamasaki Yasushi