Endoscopic Resection of Gastric Subepithelial Masses, End... | NCT01105728

Studies
Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

NCT01105728

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Apr 24, 2012Estimated

Enrollment

38Estimated

Phase

Phase 1

Conditions

Gastric Subepitelial Mass

Interventions

Endoscopic resection

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Apr 15, 2010

First Submission Date that Met QC Criteria

Apr 15, 2010

First Posted Date

Apr 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2012

Last Update Posted Date

Apr 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study arm	Experimental	Endoscopic resection	Procedure: Endoscopic resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic resection	Procedure	Endoscopic resection of the gastric subepithelial mass	Study arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
R0 Resection	Rate of R0 resections by an endoscopic approach for resection.	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Safety	Rate of complications	30 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar		Munich	Bavaria	81675	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D000069916	Endoscopic Mucosal Resection

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided