BANDIT trial

JRCT ID: jRCTs042210124

Registered date:06/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: rectal neuroendocrine tumor
• Date of first enrollment: 10/05/2022
• Target sample size: 266
• Study type: Interventional

Intervention(s)

arm A: endoscopic submucosal dissection
arm B: endoscopic submucosal resection with ligation device

Outcome(s)

• Primary Outcome: En 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 maximum: Not applicable
• Gender: Both
• Include criteria: Patients with rectal neuroendocrine tumors of <=10 mm in size

Exclude criteria

Local 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

• Primary Sponsor: Imai Kenichiro
• Secondary Sponsor: Saito Yutaka
• Source(s) of Monetary Support: The Japanese Foundation for Research and Promotion of Endoscopy