## Protocol Section
### Identification Module
**NCT ID:** NCT04774679

**Brief Title:** Macroscopic on Cite Evaluation of EUS-FNA Specimen With 22 G Needle

**Official Title:** Macroscopic on Cite Evaluation of EUS-FNA Specimen of Gastrointestinal Tumours With Everyday Needle (22g EUS FNA Needle)

#### Organization Study ID Info
**ID:** MOSE
#### Organization
**Class:** OTHER
**Full Name:** Kocaeli University
### Status Module
#### Completion Date
**Date:** 2021-03-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-03-01

**Type:** ACTUAL

**Last Update Submit Date:** 2021-02-24

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-03-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-06

**Type:** ACTUAL

**Status Verified Date:** 2021-02

#### Study First Post Date
**Date:** 2021-03-01
**Type:** ACTUAL
**Study First Submit Date:** 2021-02-06
**Study First Submit QC Date:** 2021-02-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kocaeli University

#### Responsible Party

**Investigator Affiliation:** Kocaeli University

**Investigator Full Name:** Hasan Yılmaz

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In order for the diagnosis of digestive system tumors and their appropriate treatment afterward, the type of these tumors should be determined by the pathologist. Pathology doctors need sufficient tissue (a small part of the organ thought to be diseased) to make a diagnosis. Tissue samples were taken from the patients by biopsy procedure. It is examined with microscopes by performing various staining and occasionally it is reported that sufficient tissue cannot be provided to make a diagnosis. In this case, patients may be subjected to repeated biopsy procedures. The aim of this study is to investigate whether the biopsy material obtained by endoscopic ultrasonography (EUS) is sufficient for the diagnosis of the pathology physician with the naked eye. Researchers will try to determine to what extent the physician performing the biopsy procedure can predict whether the tissue he has obtained is sufficient for the pathologist. In this way, researchers think that fewer biopsy repetitions will be needed in the future.

**Detailed Description:** This study was designed to improve the acquisition of sufficient tissue (EUS-FNA) with endosonography-assisted fine needle aspiration biopsy, which has been approved and used worldwide for the diagnosis of digestive system diseases. The procedure to be applied in the study is to determine the visible tissue fragments in the sample to be taken after the standard EUS-FNA procedure and to compare it with the diagnosis made by the pathologist. Patients with a tumor detected in the digestive system and referred to the investigation unit for tissue diagnosis will be included in this study. The data obtained in the study will be collected prospectively and will be analyzed retrospectively.

### Conditions Module

**Conditions:**

- GI Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All patients who underwent EUS Guided biopsy

**Intervention Names:**

- Procedure: Endosonographic fine needle aspiration biopsy

**Label:** Biopsy Arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Biopsy Arm

**Description:** An endoscopic ultrasound device will be inserted to the stomach and biopsy will performed with a needle

**Name:** Endosonographic fine needle aspiration biopsy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Macroscopic appearance of the tissue fragments obtained by 22G EUS-FNA needle will be assessed by the endoscopist immediately in the endoscopy room. Endoscopits will decide the tissue acquisition is adequate. The diagnostic yield of the specimens determined by a pathologist will be compared to the endoscopist's first decision according to the macroscopic appearance.

**Measure:** Correlation of a macroscopically visible fragments in the 22g EUS-FNA needle specimens with final histologic diagnosis

**Time Frame:** 1-2 weeks

#### Secondary Outcomes

**Description:** Macroscopically visiable core size obtained via 22G EUS -FNA needle and pathologic size of cores will be compared by using

**Measure:** Area Under the size of the macroscopically visible core size versus histologic core size

**Time Frame:** 1-2 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. İn the age range of 18-80 years old
2. Tumour detected withcross-sectional imagined technics in the digestive system

Exclusion Criteria:

1. Refuse to give written informed consent
2. Established bleeding disorder
3. INR\>1.5IU plaelet count \<100000/dL

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gyrusus@yahoo.com

**Name:** Hasan Yılmaz

**Phone:** +905058774821

**Role:** CONTACT

**Contact 2:**

**Email:** dralierkanduman@hotmail.com

**Name:** Ali Erkan Duman

**Phone:** +905335640607

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Izmit

**Contacts:**

***Contact 1:***

- **Email:** gyrusus@yahoo.com

- **Name:** Hasan Yılmaz, MD

- **Phone:** +905058774821

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Kocaeli University Medical Faculty Hospital

**State:** Kocaeli

**Status:** RECRUITING

**Zip:** 41001

### IPD Sharing Statement Module

**Access Criteria:** publicly

**Description:** Data will be shared at Mendeley data sharing platform freely and publicly

**Info Types:**

- STUDY_PROTOCOL

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** 1 month after the study compilation

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
