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

History of Changes

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:

Genetics Home Reference related topics: Marfan syndrome

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

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

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

Additional relevant MeSH terms:

Marfan Syndrome
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities

Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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