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

Tracking Information

First Received Date ^ICMJE

April 15, 2010

Last Updated Date

April 23, 2012

Start Date ^ICMJE

April 2010

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

R0 Resection [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Rate of R0 resections by an endoscopic approach for resection.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01105728 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Rate of complications

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

Official Title ^ICMJE

Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

Brief Summary

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).

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gastric Subepitelial Mass

Intervention ^ICMJE

Procedure: Endoscopic resection

Endoscopic resection of the gastric subepithelial mass

Study Arm (s)

Experimental: Study arm

Endoscopic resection

Intervention: Procedure: Endoscopic resection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2012

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01105728

Other Study ID Numbers ^ICMJE

2632/09

Has Data Monitoring Committee

Responsible Party

Prof. Dr. Alexander Meining, Klinikum rechts der Isar

Study Sponsor ^ICMJE

Technische Universität München

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Technische Universität München

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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