Bleeding after gastric endoscopic submucosal dissection in patient taking antithrombotic drugs.
Conditions
Interventions
Endoscopic closure using the MANTIS Clip to prevent bleeding after gastric endoscopic submucosal dissection in patient taking antithrombotic drugs.
Sponsors
Ono Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who are taking antithrombotic drugs (or are taking them off) and are scheduled to have a BEST-J score of 3 or more at the time of protocol treatment. (2)Diagnosed with early gastric cancer, gastric adenoma, or suspected of having such cancer. (3)The lesion is scheduled to be removed by ESD. (4)Even if multiple lesions, including those in other organs such as the esophagus and duodenum, have been identified, only the single gastric lesion targeted by this study will be resected. However, if multiple gastric lesions are located close together and will be resected in one section, this is acceptable. (5)The mucosal defect after ESD can be closed or is unlikely to cause stenosis due to closure. In other words, all of A) to D) below are met. A)Regardless of the location of the tumor, the extent of resection by ESD is judged to be less than 2/3 circumferential. B)Regardless of the location of the tumor, the length of the resected specimen after ESD is judged to be 5 cm or less. C)The oral margin of the tumor does not extend beyond the esophagogastric junction, unless it does extend beyond the esophagogastric junction if the extent of ESD resection is deemed to be less than 1/2 circumference. D)The anal margin of the tumor does not touch the pylorus ring. However, if the extent of ESD resection is deemed to be less than 1/2 circumference, the tumor may touch the pylorus ring. (6)Age 18 or older at the time of consent acquisition. (7)Patients who have received sufficient information about participating in the study and have given their voluntary written consent.
Exclusion criteria
Exclusion criteria: (1) Patients with a tendency to bleed: - Platelet count less than 50,000/uL or PT-INR 3.0 or higher while on antithrombotic therapy. (2) Patients with nickel sensitivity. (3) Patients with a history of gastrectomy (including gastric tube patients). (4) Patients who are deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of postoperative bleeding. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Closure time (a major secondary outcome). (2)Success rate of closure. (3)Percentage of patients with closure retention 7 days after treatment. (4)Number of MANTIS Clips used. (5)Adverse events (intraoperative perforation, delayed perforation, aspiration pneumonia). (6)Proportion of medical device defects. | — |
Contacts
Public ContactEiichiro Yokoyama
Shizuoka Cancer Center
Outcome results
None listed