Other Specified Disorders of Esophagus, Stomach or DuodenumNCT02025244

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

A study testing Key Hole Biopsy ( KHB) and EUS-FNA in people with Other Specified Disorders of Esophagus, Stomach or Duodenum, run by Vitkovice Hospital at 2 sites in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 95 years
Conditions the study is for: Other Specified Disorders of Esophagus, Stomach or Duodenum
What is being tested?: Key Hole Biopsy ( KHB) and EUS-FNA
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 2 sitesCzechia
Study dates: Nov 2010to Dec 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 .

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Vincent Zoundjiekpon, MD contact

00420608080209

vincent04@post.cz

Czechia2 sites, 2 recruiting

Digestive Diseases Center, Vitkovice Hospital
Ostrava, Ostrava, 703 84
Recruiting
Digestive Diseases Center, Vitkovice Hospital
Ostrava, Ostrava, 70384
Vincent Zoundjiekpon, MD, 00420608080209, vincent04@post.cz
Vincent Zoundjiekpon, MD
Recruiting

Other trials in Czechia

About this study

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

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.

Read the 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.

Conditions: Other Specified Disorders of Esophagus, Stomach or Duodenum
Being tested: Key Hole Biopsy ( KHB), EUS-FNA
Keywords: Key hole biopsy, Upper Gastrointestinal Submucosal Tumors, EUS-FNA, Mitototic Activity, GIST

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Key Hole Biopsy ( KHB)Procedure or surgery
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-FNAProcedure or surgery
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.

Study groups in NCT02025244
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Key Hole Biopsy ( KHB); Procedure: EUS-FNA

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 5 years

Secondary outcomes (1)

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.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Dec 2015

First posted31 Dec 2013 (estimated)
Study startNov 2010
Primary completionDec 2013
Study completionDec 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Other Specified Disorders of Esophagus, Stomach or DuodenumStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 52 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02025244
Sponsor's protocol ID: DDC VN 05
Status last verified: Nov 2015
First submitted: 14 Oct 2012
Last updated: 24 Nov 2015
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 31025658

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Endosonography-Guided Fine-Needle-Aspiration (EUS-FNA) Versus Key Hole Biopsy (KHB) in Diagnostics of Upper Gastrointestinal Submucosal Tumors - a Randomized Trial
ClinicalTrials.gov ID: NCT02025244
Acronym / sponsor ID: DDC VN 05
Conditions: Other Specified Disorders of Esophagus, Stomach or Duodenum
Keywords: Key hole biopsy, Upper Gastrointestinal Submucosal Tumors, EUS-FNA, Mitototic Activity, GIST
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 52 participants (estimated)
Lead sponsor: Vitkovice HospitalUniversity, hospital or other
Study start: Nov 2010
Primary completion: Dec 2013 (actual)
Study completion: Dec 2015 (estimated)
First posted: 31 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients with endoscopically detected submucosal tumors of Upper GUT with diameter ≥ 2cm are enrolled in the trial.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Key Hole Biopsy	Active comparator	Procedure: Key Hole Biopsy ( KHB), Procedure: EUS-FNAPatients 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	Active comparator	Procedure: Key Hole Biopsy ( KHB), 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 the mitotic activity is evaluated.

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 .

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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 or surgery	EUS-FNA, Key Hole Biopsy
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.	Procedure or surgery	EUS-FNA, Key Hole Biopsy

Primary outcome

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
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).

1 secondary outcome

Detection of mitotic activity in case of Gastrointestinal Stromal Tumors
Time frame: 5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
Derived from this study: PubMed 31025658Zoundjiekpon 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vincent Zoundjiekpon, MD contact

00420608080209

vincent04@post.cz

Vincent Zoundjiekpon, MD principal investigator

Vitkovice Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Key Hole Biopsy ( KHB) and EUS-FNA in people with Other Specified Disorders of Esophagus, Stomach or Duodenum, run by Vitkovice Hospital at 2 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vincent Zoundjiekpon, MD (00420608080209, vincent04@post.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02025244, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2015.