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An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Hemostasis Using an Endoscopic water Irrigation Pump for Underwater Endoscopic Submucosal Dissection in Patients with Superficial Gastric Tumors.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Superficial gastric tumor
Date of first enrollment	27/02/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	1. Flushing Group The procedure was performed according to the fol lowing seven steps: (1) Mucosal injection (2) Partial circumferential incision (3) Creation of a mucosal flap (4) Partial submucosal dissection (5) Complete circumferential incision (6) Submucosal dissection (7) En bloc resection of the lesion During submucosal dissection, persistent bleeding and arterial bleeding were managed using the Flus hing Forced Method, which involves hemostasis w ith forced coagulation mode (effect 6.5) synchroni zed with waterjet delivery via the EIP2 system. If hemostasis could not be achieved by this metho d alone, additional hemostasis was performed usi ng hemostatic forceps (Coagrasper G) with soft co agulation mode (effect 6, 100 W). 2. 1-10 Method Group The procedure was performed according to the fol lowing seven steps: (1) Mucosal injection (2) Partial circumferential incision (3) Creation of a mucosal flap (4) Partial submucosal dissection (5) Complete circumferential incision (6) Submucosal dissection (7) En bloc resection of the lesion During submucosal dissection, persistent bleeding and arterial bleeding were controlled using the 1- 10 Method, which employs forced coagulation mo de with an effect setting of 0.4. If hemostasis could not be achieved by this method alone, additional hemostasis was performed usi ng hemostatic forceps (Coagrasper G) with soft co agulation mode (effect 6, 100 W).

Outcome(s)

Primary Outcome	Hemostatic time for the initial bleeding episode
Secondary Outcome	1. Efficacy-related outcomes (hemostatic time for all episodes of bleeding, usage rate of hemostatic f orceps, dissection time, dissection speed, en-bloc complete resection rate, endoscopic curability) 2. Safety-related outcomes (adverse events)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Subject who are 18 years of age and more 2. Subject who understand and voluntarily sign an informed consent form. 3. Subjects who have superficial gastric neoplasm meeting the absolute or expanded indication for E SD according to the following Japanese guidelines for gastric treatment (6 edition): i) clinically diagnosed intramucosal cancer (cT1a) representing well differentiated-type adenocarcin oma of any size, without ulcerative findings ii) cT1a representing well-differentiated-type aden ocarcinoma, less than 30 mm in size, with ulcerati ve findings iii) cT1a representing undifferentiated-type adeno carcinoma, less than 20 mm in size, without ulcera tive findings. 4. Subject who have computed tomography findin gs without any suspicious lesions of lymph node metastasis and distant metastasis. 5. Subject who have histological findings of group 3, 4, and 5 according to group classification of ga stric biopsy. 6. Eastern Cooperative Oncology Group (ECOG) P erformance Status: 0-2 7. Patients scheduled for ESD
Exclude criteria	1.Patients receiving antithrombotic therapy 2.Patients with impaired hemostatic or coagulation function (platelet count < 100000 per uL or PT-INR > 1.5) 3.Patients starting dialysis 4.Patients previously enrolled in this clinical study for another lesion 5.Patients with dysfunction of any vital organ meeting any of the following criteria: Liver: AST or ALT >= 3 times the upper limit of normal, or Child-Pugh class B or higher Kidney: eGFR < 30 mL/min/1.73 m2 or serum creatinine > 1.5 mg/dL Heart: NYHA class 3 or higher heart failure 6.Patients with electrolyte abnormalities meeting any of the following criteria: Serum Na < 130 mEq/L or > 150 mEq/L Serum K < 3.0 mEq/L or > 5.5 mEq/L Serum Cl < 90 mEq/L or > 110 mEq/L 7.Pregnant women, women who may be pregnant, or breastfeeding women 8. Patients deemed unsuitable for sedation (e.g., history of allergy or hypersensitivity to benzodiazepines or dexmedetomidine; prior radiotherapy involving the cervical esophagus; or anticipated difficult airway management due to airway stenosis, anatomical abnormalities, or prior difficult intubation) 9.Any other patients judged inappropriate for this clinical study by the investigators