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Submucosal Tumor Removal by Endoscopic Excision Therapy

Prospective One-armed Observational Study of Full-thickness Resection of Small Hypoechoic Submucosal Gastric Tumors (≤2 cm)

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04913077
Acronym
STREET
Enrollment
200
Registered
2021-06-04
Start date
2020-03-10
Completion date
2025-02-28
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Submucosal Tumor of Stomach

Keywords

Submucosal Tumor of Stomach, GIST, FTRD

Brief summary

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.

Detailed description

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: 1. The frequency of GIST tumors among submucous tumors/lesions (SMT) in the stomach is unclear. Gastroenterological series always contain smaller GIST tumors, but are reported almost exclusively from clinics. The rate of these tumors in the overall collective of patients seen in the field of (mostly established) gastroenterologists is thus completely unclear. Surgical or oncological series have usually included more aggressive tumors consisting mainly or exclusively of GIST tumors, therefore do not allow epidemiological conclusions. 2. If no surgery is performed (and thus a definitive histology is forced), only information from follow-up examinations remains. Previous follow-up studies show the dilemma of insufficient differential diagnosis of lesions by endosonography and (endosonographic or other) biopsy, which usually have insufficient accuracy. In addition, the follow-up time in the studies hardly extends beyond 2 years. The gastroenterological gut instinct that these small lesions are not dangerous may be true, but is not proven.

Interventions

OTHERremoval 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

Sponsors

Ovesco Endoscopy AG
CollaboratorINDUSTRY
Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Submucosal gastric Tumors up to 2 centimeters of size

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of GIST tumorsthrough study completion, approximately 2 yearsRate of GIST tumors in a preferably unselected patient cohort of small submucous gastric tumors in which histology is not known

Secondary

MeasureTime frameDescription
Complication ratethrough study completion, approximately 2 yearsComplication rate of the chosen resection technique
influencing factors on the GIST rate: tumor sizethrough study completion, approximately 2 yearsInfluence of tumor size on the GIST rate
Influencing factors on the GIST rate: position of tumorthrough study completion, approximately 2 yearsInfluence of tumor position in the stomach
Influencing factors on the GIST rate: endoscopic ultrasound imagethrough study completion, approximately 2 yearsendoscopic ultrasound image with pattern and position in the wall
Technical successthrough study completion, approximately 2 yearsTechnical success rate (R0/R1 resection) of the chosen resection technique
Influencing factors on the GIST rate: patient's genderthrough study completion, approximately 2 yearsgender of patients
Influencing factors on the GIST rate: anamnesisthrough study completion, approximately 2 yearsanamnesis including initial diagnosis
Patient's preferred approachthrough study completion, approximately 2 yearsPatient preferences for removal (consent rate for the study) versus follow-up
data for cost-benefit calculationthrough study completion, approximately 2 yearsEstablishment of a date base for a cost-benefit calculation comparing follow-up vs. removal
Influencing factors on the GIST rate: patient's agethrough study completion, approximately 2 yearsAge of patients

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026