Table 1 Inclusion and exclusion criteria of the study

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 15 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