Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-09-01

Brief Summary

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Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.

Detailed Description

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Conditions

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Feasibility, Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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EFTR

EFTR with the FTRD developed for gastric resection (gFTRD).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Gastric SET up to 15 mm (measurement: endoscopic ultrasound)

Exclusion Criteria

* Age \< 18 years
* Gastric SET \> 15 mm and/or large extramural part
* Criteria of Lipoma (endoscopic ultrasound)
* Positive lymph nodes (endoscopic ultrasound)
* Stenosis (Esophagus)
* Diverticulum (Esophagus)
* Pregnancy or Nursing period

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinikum Ludwigsburg

Ludwigsburg, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Benjamin Meier

Role: primary

[email protected]

Karel Caca

Role: backup

[email protected]

004971419967201

References

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Meier B, Schmidt A, Glaser N, Meining A, Walter B, Wannhoff A, Riecken B, Caca K. Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial). Surg Endosc. 2020 Feb;34(2):853-860. doi: 10.1007/s00464-019-06839-2. Epub 2019 Jun 11.

Reference Type DERIVED

PMID: 31187233 (View on PubMed)

Other Identifiers

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RESET

Identifier Type: -

Identifier Source: org_study_id