Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD (RESET)

September 15, 2017 updated by: Kliniken Ludwigsburg-Bietigheim gGmbH
Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

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

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

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with gastric SET

Description

Inclusion Criteria:

  • Age > 18 years
  • Gastric SET up to 15 mm (measurement: endoscopic ultrasound)

Exclusion Criteria:

  • Age < 18 years
  • Gastric SET > 15 mm and/or large extramural part
  • Criteria of Lipoma (endoscopic ultrasound)
  • Positive lymph nodes (endoscopic ultrasound)
  • Stenosis (Esophagus)
  • Diverticulum (Esophagus)
  • Pregnancy or Nursing period

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 1 minute (immediate)
Successful enbloc- and macroscopically complete resection
1 minute (immediate)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0-Resection
Time Frame: three days
Histologically confirmed complete resection
three days
Histologically confirmed full thickness resection
Time Frame: three days
Histologically confirmed full thickness resection
three days
Procedure-associated complications
Time Frame: three months
Procedure-associated complications such as bleeding or perforation
three months
Necessity of surgical treatment
Time Frame: three months
Necessity of surgical treatment
three months
Residual or recurrent adenoma/carcinoma at endoscopic follow up
Time Frame: three months
Residual or recurrent adenoma/carcinoma at endoscopic follow up
three months

Collaborators and Investigators

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

Sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH

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 1, 2017

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (ACTUAL)

March 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • RESET (Alias Study Number)

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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