Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study (EndoResect)

April 23, 2012 updated by: Technical University of Munich
Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic resection of gastric subepithelial masses is investigated. Since there is a certain risk of perforation due to the procedure, perforations get closed by placement of endoscopic clips (over-the-scope-clip [OTSC] clips).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During an initial pilot phase 8 patients receive endoscopic resection under laparoscopic control. Thereafter and after positive initial results sole endoluminal endoscopy is done for a total of 38 patients.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 1

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
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Klinikum rechts der Isar

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Endosonographically suspicous gastric subepithelial mass <=3 cm.

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) classes IV or V
  • Pregnancy
  • Bleeding disorders
  • Contraindications for endoscopy
  • Endosonographically shown large vessels in the area for resection

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: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study arm
Endoscopic resection
Procedure: Endoscopic resection
Endoscopic resection of the gastric subepithelial mass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 Resection
Time Frame: 30 minutes
Rate of R0 resections by an endoscopic approach for resection.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 30 minutes
Rate of complications
30 minutes

Collaborators and Investigators

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

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Alexander Meining, MD, Klinikum rechts der Isar
  • Principal Investigator: Stefan von Delius, MD, Klinikum rechts der Isar
  • Principal Investigator: Hubertus Feußner, MD, Klinikum rechts der Isar
  • Principal Investigator: Dirk Wilhelm, MD, Klinikum rechts der Isar

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

April 1, 2010

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 15, 2010

First Posted (ESTIMATE)

April 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2012

Last Update Submitted That Met QC Criteria

April 23, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2632/09

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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