Inclusion criteria+A2:C14 | Exclusion criteria |
---|---|
1) Patients with SNADET without extension to the submucosa eligible for ESD by consensus diagnosis among specialists in gastroenterology | 1) Patients who are diagnosed as SNADET on the duodenal bulbus |
2) Patients with tumor size of at least 15Â mm | 2) Patients with muscular degenerative disease |
3) Patients aged between 20 years and 80 years at the time of consent | 3) Patients with metastases to lymph nodes |
4) Patients who provide written informed consent for participation in this clinical trial | 4) Patients with history of upper abdominal surgery |
 | 5) Patients with hypersensitivity to Factor XIII with fibrinogen (Fibrin glue), gentamicin, amphotericin B, or human serum albumin, or with previous bovine allergy or severe metal allergy |
 | 6) Patients undergoing treatment with coagulation accelerator (snake venom), antifibrinolytic agent, or aprotinin |
 | 7) Patients with preexisting alcohol poisoning or drug dependence within 6 months before the provisional registration |
 | 8) Patients with malignancy other than SNADET within 5 years before the provisional registration |
 | 9) Patients positive for HIV-1 or HIV-22, HBV, HCV, or HTLV, patients with active infection, patients with or suspected of being infected with transmissible spongiform encephalopathy, and patients with major neurocognitive disorder |
 | 10) Patients who are pregnant or at risk of becoming pregnant |
 | 11) Patients with psychosis or psychiatric symptoms as complications and who are judged difficult to participate in the clinical trial |
 | 12) Other patients who are deemed inadequate to participate in the clinical trial at the discretion of the investigator |