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Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study


Phase 1
18 Years
N/A
Not Enrolling
Both
Gastric Subepitelial Mass

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Trial Information

Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

R0 Resection

Outcome Description:

Rate of R0 resections by an endoscopic approach for resection.

Outcome Time Frame:

30 minutes

Safety Issue:

No

Principal Investigator

Alexander Meining, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum rechts der Isar

Authority:

Germany: Ethics Commission

Study ID:

2632/09

NCT ID:

NCT01105728

Start Date:

April 2010

Completion Date:

January 2012

Related Keywords:

  • Gastric Subepitelial Mass
  • Gastric subepitelial mass
  • Endoscopic full thickness resection
  • Marfan Syndrome

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