Submucosal Tumor Removal by Endoscopic Excision Therapy (STREET)

March 17, 2024 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany, 79106
        • University Hospital Freiburg
      • Hamburg, Germany, 20246
        • University Hospital Hamburg Eppendorf
      • Marburg, Germany, 35039
        • University Hospital Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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
Other Names:
  • Endoscopic submucosal dissection (ESD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of GIST tumors
Time Frame: 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
through study completion, approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: through study completion, approximately 2 years
Technical success rate (R0/R1 resection) of the chosen resection technique
through study completion, approximately 2 years
Complication rate
Time Frame: through study completion, approximately 2 years
Complication rate of the chosen resection technique
through study completion, approximately 2 years
influencing factors on the GIST rate: tumor size
Time Frame: through study completion, approximately 2 years
Influence of tumor size on the GIST rate
through study completion, approximately 2 years
Influencing factors on the GIST rate: position of tumor
Time Frame: through study completion, approximately 2 years
Influence of tumor position in the stomach
through study completion, approximately 2 years
Influencing factors on the GIST rate: endoscopic ultrasound image
Time Frame: through study completion, approximately 2 years
endoscopic ultrasound image with pattern and position in the wall
through study completion, approximately 2 years
Influencing factors on the GIST rate: patient's age
Time Frame: through study completion, approximately 2 years
Age of patients
through study completion, approximately 2 years
Influencing factors on the GIST rate: patient's gender
Time Frame: through study completion, approximately 2 years
gender of patients
through study completion, approximately 2 years
Influencing factors on the GIST rate: anamnesis
Time Frame: through study completion, approximately 2 years
anamnesis including initial diagnosis
through study completion, approximately 2 years
Patient's preferred approach
Time Frame: through study completion, approximately 2 years
Patient preferences for removal (consent rate for the study) versus follow-up
through study completion, approximately 2 years
data for cost-benefit calculation
Time Frame: through study completion, approximately 2 years
Establishment of a date base for a cost-benefit calculation comparing follow-up vs. removal
through study completion, approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Ovesco Endoscopy AG

Investigators

  • Principal Investigator: Thomas Rösch, Prof. Dr., Universitatsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 23, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV7129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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