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Trial record 223 of 350 for:    Gastrointestinal Stromal Tumors
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Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

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ClinicalTrials.gov Identifier: NCT02488746
Recruitment Status : Terminated (According to study protocol the trial was terminated because the recruitment of trial participants was insufficient.)
First Posted : July 2, 2015
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
Kliniken Ludwigsburg-Bietigheim gGmbH

Study Description
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Brief Summary:
Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.

Condition or disease Intervention/treatment
Gastric Neoplasms Gastrointestinal Stromal Tumors Device: GERDX(TM)

Study Design
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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)
Study Start Date : March 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Group/Cohort Intervention/treatment
EFTR-GERDX
Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.
 Device: GERDX(TM)
Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved [ Time Frame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available) ]
  2. Rate of complications (bleeding, perforation) [ Time Frame: 6 months after resection ]
  3. Duration of hospitalization [ Time Frame: within one week after resection ]
  4. Number of participants with local or systemic recidive of tumor [ Time Frame: 6 months after resection ]
  5. Number of participants with needs of surgical therapy or endoscopic re-resection [ Time Frame: 6 months after resection ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in which a subepithelial gastric tumor has been detected (in our hospital, other hospitals or by transferring doctor).
Criteria

Inclusion Criteria:

  • presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
  • age 18 years or older
  • participant has given informed consent

Exclusion Criteria:

  • tumor size > 40 mm (endosonographic measurement) or large extramural tumor mass
  • signs of systemic dissemination of tumor
  • current presence of a different neoplastic disease (except after successful curative treatment without continued medication)
  • former surgery or disease of esophagus or stomach that impedes insertion of the suturing device
  • moribund patient
  • limited possibility to give informed consent (e.g. language barrier, psychiatric disease)
  • pregnancy and lactation period
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488746


Locations
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Germany
Klinikum Ludwigsburg
Ludwigsburg, Baden-Württemberg, Germany, 71640
Sponsors and Collaborators
Kliniken Ludwigsburg-Bietigheim gGmbH
Investigators
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Study Chair: Karel Caca, Prof. Dr. Klinikum Ludwigsburg
More Information
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Responsible Party: Kliniken Ludwigsburg-Bietigheim gGmbH
ClinicalTrials.gov Identifier: NCT02488746    
Other Study ID Numbers: FROST
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Stomach Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Stomach Diseases