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Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

T

Technical University of Munich

Status and phase

Completed
Phase 1

Conditions

Gastric Subepitelial Mass

Treatments

Procedure: Endoscopic resection

Study type

Interventional

Funder types

Other

Identifiers

NCT01105728
2632/09

Details and patient eligibility

About

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).

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Study arm
Experimental group
Description:
Endoscopic resection
Treatment:
Procedure: Endoscopic resection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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