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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Vitkovice Hospital
Sponsor:
Information provided by (Responsible Party):
Vincent Zoundjiekpon, Vitkovice Hospital
ClinicalTrials.gov Identifier:
NCT02025244
First received: October 14, 2012
Last updated: December 29, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Vincent Zoundjiekpon, MD, Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT02025244     History of Changes
Other Study ID Numbers: DDC VN 05
Study First Received: October 14, 2012
Last Updated: December 29, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 22, 2014