gastric submucosal tumor
Conditions
Interventions
The study will be divided into three phases with a total of 13 patients. In all cases, EFTR will be performed by physicians who meet certain criteria and are skilled in endoscopic procedures. Phase 1
Sponsors
National Cancer Center Hospital Endoscopy Division Yutaka Saito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility Criteria 1) Preoperative diagnosis of gastric submucosal tumor between 2 cm and 3 cm by CT and ultrasound endoscopy (EUS) 2) A gastric submucosal tumor of 2 cm or less that meets one of the following conditions a) GIST (gastrointestinal stromal tumor) diagnosed or suspected by imaging or histological diagnosis b) Suspected malignant findings such as ulceration, irregular margins, or tendency to enlarge. 2) Patients who can be resected by laparoscopic local excision (including LECS) at the institution 3) The line of resection does not extend to the spleen or pylorus, and there is no problem with endoscopic movement during preoperative endoscopy, and EFTR is judged to be feasible *1 4) It is judged that there is sufficient space for full-layer suture after EFTR. 5) Gastric submucosal tumor is of intraductal or intramural type. 6) No previous epigastric surgery and no previous surgery involving resection of the intestinal tract (including the stomach). However, patients with no postoperative ileus despite a history of the following examinations and surgeries are acceptable. (1) Laparoscopy or laparoscopic and laparoscopic (assisted) appendicectomy for appendicitis Laparoscopic cholecystectomy for cholelithiasis Laparoscopic and laparoscopic (assisted) resection of the sigmoid colon 4) Open and laparoscopic (assisted) resection of the rectum (without stoma) 7) Age at enrollment: 18 years or older 8) Performance status (PS) of 0-1 according to ECOG criteria 9) Patient's written consent to participate in the study 1 The three cases in the first stage are defined as lesions with tumor margins more than 3 cm away from the eruption/pylorus.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1) Gastric submucosal tumor of extrapubic origin 2) Temporary withdrawal of antiplatelet agents or anticoagulants is not possible 3) Platelet count less than 50,000/mm3 or PT-INR greater than 2 in patients not taking anticoagulants 4) Patients with liver cirrhosis that falls into the B-C category on the Child-Pugh score 5) Patients with chronic renal failure on maintenance dialysis 6) Patients whose EFTR resection line is considered to extend to the spleen or pylorus. 7) Patients whose attending physician determines that participation in this study is inappropriate. Discontinuation Criteria 1) When it is considered necessary to proceed to laparotomy. 2) If the attending physician or surgeon determines that EFTR is not feasible prior to the start of ETFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of EFTR and endoscopic suturing | — |
Secondary
| Measure | Time frame |
|---|---|
| en-bloc, complete resection rate for EFTR the time required for EFTR and suturing Intraoperative and postoperative adverse event rate | — |
Countries
Japan
Contacts
Public ContactMai Makiguchi
National Cancer Center Hospital Endoscopy division
Outcome results
None listed