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

Other Specified Disorders of Esophagus, Stomach or Duodenum Clinical Trial

Official title:

Endosonography-Guided Fine-Needle-Aspiration (EUS-FNA) Versus Key Hole Biopsy (KHB) in Diagnostics of Upper Gastrointestinal Submucosal Tumors - a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02025244
• Other study ID #: DDC VN 05
• Status: Recruiting
• Phase: N/A
• First received: October 14, 2012
• Last updated: November 23, 2015
• Start date: November 2010
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Vitkovice Hospital
• Contact: Vincent Zoundjiekpon, MD
• Phone: 00420608080209
• Email: vincent04[@]post.cz
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Esophageal Diseases
• Other Specified Disorders of Esophagus, Stomach or Duodenum

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czech Republic	Digestive Diseases Center, Vitkovice Hospital	Ostrava
Czech Republic	Digestive Diseases Center, Vitkovice Hospital	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
Vitkovice Hospital

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the yield and success of KHB and EUS-FNA in cytological / histological and immunohistochemical diagnostics of Upper Gastrointestinal Submucosal Tumors.	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).	5 years	Yes
Secondary	Detection of mitotic activity in case of Gastrointestinal Stromal Tumors	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.	5 years	Yes