Patients undergoing ESD for neoplasia of the stomach and rectum
Conditions
Interventions
TDM-621
Control(Hemostatic forceps)
Sponsors
3-D Matrix, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who met all of the following items at the time of registration were included in this clinical trial. (1) An epithelial tumor with a maximum diameter of 3 cm to 6 cm (which is a single lesion) that is expected to be resected specimen for which ESD of the stomach (upper, middle) or rectum (upper, lower) is indicated Patients with (Based on the guidelines for gastric cancer/colon cancer treatment and stomach/colon ESD/EMR guidelines) Stomach: A differentiated cancer that is macroscopically diagnosed as intramucosal cancer (T1a) and is UL (-). Rectum: Preoperatively diagnosed with adenoma, intramucosal cancer, or mild invasive cancer in the submucosa (2) Patients aged 20 years or older at the time of obtaining consent (3) Patients who understand the content of the consent explanation document and can freely consent to the document (4) Patients who can visit the hospital and can be examined on a designated examination date such as examination schedule (5) Patients who are hospitalized or will be hospitalized
Exclusion criteria
Exclusion criteria: Subjects who met any of the following items at the time of enrollment were excluded from this trial. (1) Patients with local residual recurrence (2) Patients with ulcer in the target lesion (3) Poorly differentiated adenocarcinoma or undifferentiated cancer gastric cancer patients and rectal cancer patients (4) Patients with inflammatory bowel disease including ulcerative colitis (5) Patients with a history of hypersensitivity to peptide or protein products (6) Patients with Grade 2 or higher of Performance status according to the clinical evaluation criteria of cancer chemotherapy (7) Patients with serious liver disease, renal disease, cardiovascular disease, etc. [Assessment of severity of adverse event grade 3 or more in the Common Terminology Criteria for Adverse Events] (8) Patients with a condition in which reticuloendothelial system activity may be decreased such as disseminated intravascular coagulation (9) Patients who are receiving blood coagulation drugs (coagulation promoter = hemocoagulase, etc.), antifibrinolytic drugs (drugs having antifibrinolytic action = tranexamic acid, aprotinin preparation, etc.). However, regardless of the use of antiplatelet drugs, the drug should be discontinued in accordance with the guideline for gastrointestinal endoscopy for patients taking antithrombotic drugs. (10) Patients who are scheduled to undergo heparin replacement for ESD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the number of coagulation by hemostatic forceps required to achieve intraprocedural haemostasis in TDM-621 versus control groups. | — |
Countries
Japan
Contacts
Public Contactsatoru kobayashi
3D-Matrix, Ltd Business Development
Outcome results
None listed