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

V

Vitkovice Hospital

Status

Unknown

Conditions

Other Specified Disorders of Esophagus, Stomach or Duodenum

Treatments

Procedure: Key Hole Biopsy ( KHB)
Procedure: EUS-FNA

Study type

Interventional

Funder types

Other

Identifiers

NCT02025244
DDC VN 05

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

52 participants in 2 patient groups

Key Hole Biopsy
Active Comparator group
Description:
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.
Treatment:
Procedure: EUS-FNA
Procedure: Key Hole Biopsy ( KHB)
EUS-FNA
Active Comparator group
Description:
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.
Treatment:
Procedure: EUS-FNA
Procedure: Key Hole Biopsy ( KHB)

Trial contacts and locations

2

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Central trial contact

Vincent Zoundjiekpon, MD

Data sourced from clinicaltrials.gov

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