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EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors

This study is currently recruiting participants.
Verified November 2015 by Vincent Zoundjiekpon, Vitkovice Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02025244
First Posted: December 31, 2013
Last Update Posted: November 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Vincent Zoundjiekpon, Vitkovice Hospital
  Purpose
Upper Gastrointestinal Submucosal Tumors are tumors arising from subepithelial layers of esophageal, gastric or duodenal wall. They usually have an intact mucosa lining on the inner surface. The prognosis and treatment of these tumors depend on their correct diagnostics and mitotic activity in case of Gastrointestinal Stromal Tumors (GIST). A standard forceps biopsy of mucosa is usually not helpful. Therefore, biopsy techniques capable of reaching deeper layer of Upper GUT are needed. The investigators compare KHB and EUS-FNA in the diagnostics of Upper gastrointestinal Submucosal Tumors.

Condition Intervention
Other Specified Disorders of Esophagus, Stomach or Duodenum Procedure: Key Hole Biopsy ( KHB) Procedure: EUS-FNA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Endosonography-Guided Fine-Needle-Aspiration (EUS-FNA) Versus Key Hole Biopsy (KHB) in Diagnostics of Upper Gastrointestinal Submucosal Tumors - a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Vincent Zoundjiekpon, Vitkovice Hospital:

Primary Outcome Measures:
  • To compare the yield and success of KHB and EUS-FNA in cytological / histological and immunohistochemical diagnostics of Upper Gastrointestinal Submucosal Tumors. [ Time Frame: 5 years ]
    Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are randomized and then are allocated to either EUS-FNA by 22G needle or KHB consisting of forceps biopsy through mucosal incision by a needle knife, both with subsequent histological/cytological and imunohistochemical evaluation of the specimen. The success of tissue diagnostics was evaluated.In case of failure of the initial method, the other method was performed (cross-over design).


Secondary Outcome Measures:
  • Detection of mitotic activity in case of Gastrointestinal Stromal Tumors [ Time Frame: 5 years ]
    Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are randomized and then allocated to either EUS-FNA by 22G needle or KHB consisting of forceps biopsy through mucosal incision by a needle knife, both with subsequent histological/cytological and imunohistochemical evaluation of the specimen. In case of GIST the possibility to determine the mitotic activity was evalueted.


Estimated Enrollment: 52
Study Start Date: November 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Key Hole Biopsy
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are, according to randomization, allocated to undergo esophagogastroduodenoscopy with Key Hole Biopsy consisting of forceps biopsy through mucosal incision by a needle knife, with subsequent cytological /histological and immunohistochemical evaluation of specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
Procedure: Key Hole Biopsy ( KHB)
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are, according to randomization, allocated to undergo esophagogastroduodenoscopy with Key Hole Biopsy consisting of forceps biopsy through mucosal incision by a needle knife, with subsequent cytological /histological and immunohistochemical evaluation of specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
Procedure: EUS-FNA
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine mitotic activity is evaluated. In case of failure of this method, the second one is performed.
Active Comparator: EUS-FNA
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
Procedure: Key Hole Biopsy ( KHB)
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are, according to randomization, allocated to undergo esophagogastroduodenoscopy with Key Hole Biopsy consisting of forceps biopsy through mucosal incision by a needle knife, with subsequent cytological /histological and immunohistochemical evaluation of specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
Procedure: EUS-FNA
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine mitotic activity is evaluated. In case of failure of this method, the second one is performed.

Detailed Description:

Patients with endoscopically detected submucosal tumors of Upper GUT with diameter ≥ 2cm are enrolled in the trial.

According to randomization, the patients are allocated to either EUS-FNA by 22G needle or KHB consisting of forceps biopsy through mucosal incision by a needle knife, both with subsequent histological/cytological and immunohistochemical evaluation of the specimen. The success of tissue diagnostics was evaluated as well as the possibility to determine the mitotic activity in case of GIST. In case of failure of the initial method, the other method was performed (cross-over design). Patients are hospitalized and kept under observation during 24 hours after the biopsy.

  Eligibility

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Submucosal tumor with endoscopically normal intact mucosa
  • Tumor size: 20mm or more
  • Localization of tumors: esophagus,stomach, duodenum
  • Age: 18 years and older
  • The patient´s consent with a diagnostic procedure .

Exclusion Criteria:

  • Endoscopically nonbuilding tumor
  • Patients younger than 18 years
  • Coagulopathy (INR > 1,5, platelets < 100)
  • Tumor size < 20mm
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02025244


Contacts
Contact: Vincent Zoundjiekpon, MD 00420608080209 vincent04@post.cz

Locations
Czech Republic
Digestive Diseases Center, Vitkovice Hospital Recruiting
Ostrava, Czech Republic, 703 84
Digestive Diseases Center, Vitkovice Hospital Recruiting
Ostrava, Czech Republic, 70384
Contact: Vincent Zoundjiekpon, MD    00420608080209    vincent04@post.cz   
Principal Investigator: Vincent Zoundjiekpon, MD         
Sponsors and Collaborators
Vitkovice Hospital
Investigators
Principal Investigator: Vincent Zoundjiekpon, MD Vitkovice Hospital
  More Information

Responsible Party: Vincent Zoundjiekpon, MD, Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT02025244     History of Changes
Other Study ID Numbers: DDC VN 05
First Submitted: October 14, 2012
First Posted: December 31, 2013
Last Update Posted: November 24, 2015
Last Verified: November 2015

Keywords provided by Vincent Zoundjiekpon, Vitkovice Hospital:
Key hole biopsy
Upper Gastrointestinal Submucosal Tumors
EUS-FNA
Mitototic Activity
GIST

Additional relevant MeSH terms:
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases