Prospective One-armed Observational Study of Full-thickness Resection of Small Hypoechoic Submucosal Gastric Tumors (≤2 cm)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Rate of GIST tumors
研究概览
简要总结
Smaller submucosal tumors (SMT) in the stomach are usually seen as an incidental finding during a gastroscopy, although current diagnostics usually do not clearly indicate what type of tumor it is. In summary, there is no good evidence for dealing with SMT. In this study, an endoscopic full-thickness resection, primarily with the FTRD device, is to be offered to all patients with gastric SMT without a confirmed histology seen in a certain period of time . Patients who do not want to take advantage of this are included in a systematic follow-up program.
The investigators hope to learn about the rate of so-called GIST tumors and other histologies, as well as the rate of change in the follow-up group.
Also, study contents will be accuracy of endosonographic imaging and puncture in comparison with resection histology, technical feasibility and histological completeness of the FTRD- based endoscopic (full-wall) resection option, complications of such a resection (secondary bleeding and dehiscences), and patient preferences with standardized information.
详细描述
Smaller submucous tumors in the stomach are usually seen as a random finding in gastroscopies and present a diagnostic dilemma to the doctor and patient:
type specification is usually unclear whether it is an absolutely benign (without degeneration potential) or a malignant or prone tumor (usually gastrointestinal stromal tumor, GIST). However, this is crucial for further management.
In endosonographic imaging there are only approximate values in the differential diagnosis between GIST and non-GIST, the endoscopic biopsy is too superficial, and the hit rate of endosonographic pin puncture is limited, and in most studies is less than 70% Therefore, one can only make assumptions and create a risk profile from imaging and tumor size (limit size 3 cm, partly also 2 cm). Both follow-up recommendations (rather no GIST) and laparoscopic surgical removal (proven or probable/possible GIST) are not rarely without clear preference, especially for smaller tumors.
For these indications, a simple endoscopic removal option comparable to the polypectomy in the colon (where no histological type diagnosis is made before) does not exist.
Previous studies are usually subject to bias in several directions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with endoscopically diagnosed and endosonographically confirmed submucosal tumors of 0.5 to 2 cm in the stomach without definitive histology / cytology
- •Initial diagnosis less than 2 years ago
- •No contraindication to endoscopic resection
- •Patient's informed consent
排除标准
- •Tumor size > 2 cm
- •Tumors with proven / suspected malignancy for which oncologically no endoscopic resection should be performed, i.e. for which oncological or surgical therapy is planned
- •SMT known > 2 Years
- •Patients with severe general illnesses (limited operability) or malignancies
- •Clotting disorders
- •Pregnancy
研究组 & 干预措施
Removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)
FTRD (Ovesco company) in tumors up to 10 mm and predominantly intraluminal growth directly by sucking into the cap, at 10-20 mm and/or intramural/extramural growth by prior circumcision and lateral preparation, so that the lesions can be better pulled into the cap. The procedure depends on the endosonographic extent of the findings. The lesions are pulled into the cap with grippers and other instruments and, if necessary, with a snare and then resected with FTRD
干预措施: removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD) (Other)
结局指标
主要结局
Rate of GIST tumors
时间窗: through study completion, approximately 2 years
Rate of GIST tumors in a preferably unselected patient cohort of small submucous gastric tumors in which histology is not known
次要结局
- Influencing factors on the GIST rate: position of tumor(through study completion, approximately 2 years)
- data for cost-benefit calculation(through study completion, approximately 2 years)
- Technical success(through study completion, approximately 2 years)
- influencing factors on the GIST rate: tumor size(through study completion, approximately 2 years)
- Influencing factors on the GIST rate: patient's age(through study completion, approximately 2 years)
- Influencing factors on the GIST rate: anamnesis(through study completion, approximately 2 years)
- Influencing factors on the GIST rate: endoscopic ultrasound image(through study completion, approximately 2 years)
- Complication rate(through study completion, approximately 2 years)
- Influencing factors on the GIST rate: patient's gender(through study completion, approximately 2 years)
- Patient's preferred approach(through study completion, approximately 2 years)