NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042210124

Registered date:06/01/2022

BANDIT trial

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedrectal neuroendocrine tumor
Date of first enrollment10/05/2022
Target sample size266
Countries of recruitment
Study typeInterventional
Intervention(s)arm A: endoscopic submucosal dissection arm B: endoscopic submucosal resection with ligation device

Outcome(s)

Primary OutcomeEn bloc resection with histologically tumor-free margins
Secondary Outcome(1) En bloc resection (2) Mean procedure time (3) Adverse events (4) Length of hospital stay (5) Cost analysis (6) Adverse events on resection defect closure (7) Outcomes between experts and non-expert endoscopists (8) Risk factors for incomplete resection

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients with rectal neuroendocrine tumors of <=10 mm in size
Exclude criteriaLocal recurrence after previous polypectomy attempts Inflammatory bowel disease, polyposis syndrome Hematological abnormality Active infectious disease Hemodialysis Infeasibility of suspending antithrombotic drugs Pregnant woman

Related Information

Contact

Public contact
Name Kazunori Takada
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail ka.takada@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Kenichiro Imai
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail ke.imai@scchr.jp
Affiliation Shizuoka Cancer Center