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

NCT02025244 | Unknown DMC

• 1 other identifier: DDC VN 05
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Other Specified Disorders of Esophagus, Stomach or Duodenum

Keywords

Key hole biopsy; Upper Gastrointestinal Submucosal Tumors; EUS-FNA; Mitototic Activity; GIST

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Detection of mitotic activity in case of Gastrointestinal Stromal Tumors

  5 years

Study Arms (2)

Key Hole Biopsy

ACTIVE COMPARATOR

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); Procedure: EUS-FNA

EUS-FNA

ACTIVE COMPARATOR

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); Procedure: EUS-FNA

Interventions

Key Hole Biopsy ( KHB) PROCEDURE

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; Key Hole Biopsy

EUS-FNA PROCEDURE

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.

EUS-FNA; Key Hole Biopsy

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• Endoscopically nonbuilding tumor
• Patients younger than 18 years
• Coagulopathy (INR \> 1,5, platelets \< 100)
• Tumor size \< 20mm

Sponsors & Collaborators

• Vitkovice Hospital: lead

Study Sites (2)

Digestive Diseases Center, Vitkovice Hospital

Ostrava, Ostrava, 703 84, Czechia

RECRUITING

Digestive Diseases Center, Vitkovice Hospital

Ostrava, Ostrava, 70384, Czechia

RECRUITING

Related Publications (1)

• Zoundjiekpon V, Falt P, Fojtik P, Kundratova E, Mikolajek O, Hanousek M, Reiterova K, Ziak D, Bolek M, Tchibozo A, Kliment M, Urban O. Endosonography-Guided Fine-Needle Aspiration versus "Key-Hole Biopsy" in the diagnostics of upper gastrointestinal subepithelial tumors. A prospective randomized interventional study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Mar;164(1):63-70. doi: 10.5507/bp.2019.013. Epub 2019 Apr 17.

  PMID: 31025658 DERIVED

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Vincent Zoundjiekpon, MD

  Vitkovice Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Zoundjiekpon, MD

CONTACT

00420608080209; vincent04@post.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 14, 2012
• First Posted: December 31, 2013
• Study Start: November 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

CZ (2)