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Comparison of the Clear Coajet Hemostatic effect on EMR and ESD

Not Applicable
Not yet recruiting
Conditions
Neoplasms
Registration Number
KCT0007744
Lead Sponsor
The Catholic University of Korea, Yeouido St. Mary's Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not yet recruiting
Sex
All
Target Recruitment
404
Inclusion Criteria

(1) Men and women between the ages of 18 and 85
(2) A sessile polyp larger than 1.5 cm or a lateral spreading tumor, that is decided to perform endoscopic mucosal resection or endoscopic submucosal dissection
(3) A person who has signed a written informed consent form to participate in this study

Exclusion Criteria

(1) Pedunculated polyp
(2) Patients with Coagulopathy (international normalized ratio >1.5, a partial thromboplastin time >45 s, or a platelet count <80,000/mL)

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clear Coajet effectiveness on hemostasis of intraoperative bleeding during endoscopic mucosal resection or endoscopic submucosal dissection, hemostasis success rate, time taken to hemostasis, In case you need to use other endoscopic devices such as coagulation forceps or hemoclips for additional hemostasis
Secondary Outcome Measures
NameTimeMethod
Incidence rate of side effects in both groups (such as bleeding and perforation, which are major side effects) should be investigated. Therefore, accompanied symptoms should be investigated such as melena, decreased hemoglobin level of 2 g/dL or more, dizziness, fever, nausea, vomiting, anorexia etc, Delayed bleeding rate within 30 days after resection, Tumor recurrence rate at follow-up endoscopy after 1 year
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