A randomized control trial of efficacy of endoscopic submucosal dissection using an ITknife nano for colorectal neoplasms larger than 30 mm in size

JRCT ID: jRCT1042180137

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: colorectal neoplasms
• Date of first enrollment: 26/12/2017
• Target sample size: 216
• Study type: Interventional
• Intervention(s): Patients receive endoscopic submucosal dissection (ESD) for colorectal epitherial neoplasms.

Outcome(s)

• Primary Outcome: Procedure time
• Secondary Outcome: 1) Procedure time by location (colon/ rectum). 2) Procedure time by tumor size (40 mm</ 40 mm>=). 3) Procedure time by macroscopic type (LST-G/ LST-NG). 4) Procedire time required for submucosal dissection. 5) Number of uses of the hemostatic device. 6) Treatment outcomes (en bloc resection rate, complete en bloc resection rate). 7) Complications (bleeding, perforation). 8) Relationship between preoperative difficulty factors and treatment outcomes

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1) Colorectal epitherial neoplasms, including serrated polyps which are larger than 30 mm and smaller than 50 mm. 2) Lesions classified as Laterally spreading tumor (LST). 3) Age at registration is over 20 years old. 4) Written informed consent is obtained.
• Exclude criteria: 1) Submucosal invasive cancer (cT1b). 2) Lesions can not classified as Laterally spreading tumor (LST). 3) Local recurrences/ Scar lesions. 4) Hemorrhagic disease (severe anemia or inflammatory bowel disease etc.) 5) Easy bleeding disorder. 6) Impossible to suspend anticoagulant or antiplatelet medications. 7) Female during pregnancy. 8) Inappropriate cases by investigators.

Related Information

• Primary Sponsor: Hotta Kinichi
• Secondary ID(s): UMIN000030068