gastric submucosal tumor
Conditions
Interventions
Endoscopic resection methods
Endoscopic full-thickness resection (EFTR)
*Two-channel endoscopic resection of gastric submucosal tumors is useful when resection of lesions located at the fundus or va
Sponsors
Kobara Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria for study subjects (1) Target disease Gastric submucosal tumor (2) Eligibility criteria [1] Age 85 years or less [2] American Society of Anesthesiology Classification (ASA II) or less [3]Single submucosal tumor that meets all of the following 1) No epithelial tumor with a maximum diameter of 11-30 mm on both ultrasound endoscopy (EUS) and CT imaging 2) Tumor is not an epithelial tumor according to histological diagnosis by endoscopic biopsy 3) No ulceration by upper gastrointestinal endoscopy 4) Continuous in muscle layer and mainly growing in the lumen by EUS 5) A lesion that meets any of the following criteria A histologically confirmed diagnosis of GIST is obtained Histologically confirmed diagnosis of GIST has been obtained*, Size over 2 cm, Tendency to enlarge**, One of the following malignant findings on imaging studies [a) Edge irregularity on either upper gastrointestinal endoscopy, EUS, or CT ,b) Parenchymal heterogeneity on EUS or contrast CT] *In principle, attempt histological diagnosis before surgery. **If the measurement on EUS or CT examination shows an increase of more than 20% and more than 5 mm in diameter compared to the longest diameter at the minimum on the same previous examination method (in accordance with RECIST ver1.128). [4] No metastasis to lymph nodes or distant organs [5] Latest blood test results within 60 days prior to enrollment meet all of the following a) White blood cell count over 3,000/mm3 b) Platelet count over 100000 /mm3 c) Hemoglobin over 9.0 m/dL d) AST (GOT) under 100IU/L e) ALT (GPT) under 100IU/L f) Serum creatinine under 2.0 mg/dL g) PT activity 70-140% [6] Patient's written consent to participate in the study has been obtained [7] Treatment plan has been approved by a Cancer Board involving gastroenterological surgery and internal medicine
Exclusion criteria
Exclusion criteria: [1] Active overlapping cancers (synchronous overlapping cancers and iatrogenic overlapping cancers with a disease-free interval of 5 years or less) are present. (However, lesions equivalent to intramucosal carcinoma that are considered curable by local treatment are not included in active overlapping cancers. ) [2] Patient has an infectious disease requiring systemic treatment. [3] Pregnant, possibly pregnant, or lactating women. [4] Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study. [5] Receiving continuous systemic administration (oral or intravenous) of steroids. [6] Patients with unstable angina (angina with onset or worsening within the last 3 weeks) or a history of myocardial infarction within the last 6 months. [7] Patients with uncontrolled hypertension. [8] Complicated with poorly controlled hypertension. [9] Patients on antithrombotic and anticoagulant medications who are at high risk of bleeding and who have been identified by the Japanese Society of Gastrointestinal Endoscopy's Guidelines for Gastrointestinal Endoscopy for Patients on Antithrombotic Medications and Guidelines for Gastrointestinal Endoscopy for Patients on Antithrombotic Medications -Supplement 2017 on Anticoagulants Including Direct (New) Oral Anticoagulants (DOAC), as being at high risk for bleeding and The standard recommended response to gastrointestinal endoscopy is not available. [10] Patient has diabetes mellitus that is being treated with continuous insulin use or is poorly controlled. [11] Other patients deemed by the physician to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of complete endoscopic resection (ER0) Complete endoscopic resection (ER0) is defined as no residual tumor and en bloc resection by endoscopic observation. An en bloc resection means that the tumor was resected en bloc without dividing the tumor. Endoscopic incomplete resection (ER1) is defined as when there is residual tumor endoscopically or when the tumor is resected in pieces. | — |
Secondary
| Measure | Time frame |
|---|---|
| [1] Percentage of histological complete resection (R0) Histological complete resection (R0) is defined as tumor or pseudocapsule remaining undamaged at all circumference of the tumor in a tissue section and tumor resected en bloc. R1 is defined as histologic pseudocapsule damage or segmental resection. [2] Percentage of endoscopic resection complete Endoscopic resection complete is defined as when treatment is completed using only the endoscopic resection method in this study. [3] Percentage of adverse events All adverse events are categorized according to CTCAE v5.0 and Clavien-Dindo . [4] Treatment time 1.Total treatment time (from start of localization to completion of suture), 2. Tumor resection time (from start of localization to completion of tumor resection), and 3. Suture time (from completion of tumor resection to completion of suture) are measured. [5] Length of hospital stay [6] Percentage of positive pathological diagnosis Calculate the percentage of positive diagnosis for tissue diagnosis of the final resection specimen among cases in which preoperative tissue diagnosis is possible. [7] Change in upper gastrointestinal symptoms and endoscopic findings before and 2 months after surgery [8] Upper gastrointestinal symptoms and endoscopic findings (presence of gastric food residues and findings of reflux esophagitis) will be evaluated before and 2 months after surgery. The patients are followed for 5 years with at least annual endoscopy and CT scan to check for local or distant metastases. [9] 5-year cumulative recurrence-free rate Patients diagnosed with GIST or stromal tumor with atypia on postoperative histology are followed for 5 years with at least annual endoscopy and CT scan to check for local or distant metastases. [10] 5-year cumulative survival rate (all-cause and disease-specific deaths) Patients for analysis will be followed for 5 years with at least annual endoscopy and CT scan to ascertain whether they are alive. [11] 5-year cumula | — |
Contacts
Public ContactHideki Kobara
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Outcome results
None listed