Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01105728
First received: April 15, 2010
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Gastric Subepitelial Mass
Procedure: Endoscopic resection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • R0 Resection [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Rate of R0 resections by an endoscopic approach for resection.


Secondary Outcome Measures:
  • Safety [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    Rate of complications


Estimated Enrollment: 38
Study Start Date: April 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study arm
Endoscopic resection
Procedure: Endoscopic resection
Endoscopic resection of the gastric subepithelial mass

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105728

Locations
Germany
Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
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
  More Information

No publications provided

Responsible Party: Prof. Dr. Alexander Meining, Klinikum rechts der Isar
ClinicalTrials.gov Identifier: NCT01105728     History of Changes
Other Study ID Numbers: 2632/09
Study First Received: April 15, 2010
Last Updated: April 23, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Gastric subepitelial mass
Endoscopic full thickness resection

ClinicalTrials.gov processed this record on September 16, 2014