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Other Specified Disorders of Esophagus, Stomach or Duodenum | EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors

Other Specified Disorders of Esophagus, Stomach or Duodenum research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Other Specified Disorders of Esophagus, Stomach or Duodenum

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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-FNAPatients 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Key Hole BiopsyPatients 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-FNAPatients 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.

Study Status

Unknown status

Start Date: November 2010

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: To compare the yield and success of KHB and EUS-FNA in cytological / histological and immunohistochemical diagnostics of Upper Gastrointestinal Submucosal Tumors.

Secondary Outcome: Detection of mitotic activity in case of Gastrointestinal Stromal Tumors

Study sponsors, principal investigator, and references

Principal Investigator: Vincent Zoundjiekpon, MD

Lead Sponsor: Vitkovice Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02025244

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