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

April 15, 2010
April 23, 2012
April 2010
January 2012   (final data collection date for primary outcome measure)
R0 Resection [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Rate of R0 resections by an endoscopic approach for resection.
Same as current
Complete list of historical versions of study NCT01105728 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Rate of complications
Same as current
Not Provided
Not Provided
 
Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study
Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

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).

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Subepitelial Mass
Procedure: Endoscopic resection
Endoscopic resection of the gastric subepithelial mass
Experimental: Study arm
Endoscopic resection
Intervention: Procedure: Endoscopic resection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01105728
2632/09
No
Prof. Dr. Alexander Meining, Klinikum rechts der Isar
Technische Universität München
Not Provided
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
Technische Universität München
April 2012

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