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The efficacy of pullulan phosphate as a submucosal injection material for endoscopic mucosal resection of colorectal polyps

the efficacy of pullulan phosphate in colorectal EMR

Yamasaki Yasushi

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

yasshifive@yahoo.co.jp

Toyosawa Junki

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

+81-86-235-7219

p6yr1rdk@s.okayama-u.ac.jp

Recruiting

Oct. 23, 2024

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

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.

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

Both

colorectal polyps

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.

Complete resection and no additional submucosal injection rate

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

+81-86-235-6503

Oct. 07, 2024

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