Comparision of EUS-FNB Techniques for Diagnose of Solid Pancreatic Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Besides, the optional numeber of passes for EUS-FNB has not been determined.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Comparison of Wet Suction and Dry Suction Technique in EUS-FNA for the Outcomes in Pancreatic Solid Lesions

NCT03821974

Pancreatic Solid Lesions

COMPLETED NA

Impact of Suction in the EUS-guided Fine Needle Biopsy of Solid Pancreatic Lesions

NCT04164017

Biopsy, Fine-Needle Endosonography Pancreatic Neoplasm

UNKNOWN NA

Comparsion of WT and SNP Techniques of EUS-FNB in Pancreatic Solid Mass (WESP-PSM)

NCT04605042

Pancreatic Neoplasms Diagnoses Disease

UNKNOWN NA

Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions

NCT02789371

Pancreas Neoplasms Lymphatic Metastasis Neoplasm Metastases +5 more

UNKNOWN NA

Modified Wet Suction Versus Capillary Techniques for EUS Guided Fine Needle Aspiration and Biopsy of Solid Lesions

NCT02919553

Pancreatic Cancer Stomach Neoplasms

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators aimed to design a large multicenter randomized trial to compare the diagnostic accuracy and the optimal number of passes required for EUS-FNB in solid pancreatic lesions using 22G Franseen under wet aspiration versus standard aspiration.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Pancreatic Lesions EUS-FNB

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dry suction group

22G Franseen needle biopsy with dry suction technique(The puncture needle be filled with air)

Group Type EXPERIMENTAL

Dry suction

Intervention Type PROCEDURE

The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). The stylet is removed and a 10 ml air-filled pre-vacuum syringe is attached. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.

Wet suction group

22G Franseen needle biopsy with wet suction(The puncture needle be filled with saline before sugry)

Group Type ACTIVE_COMPARATOR

Wet suction

Intervention Type PROCEDURE

The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). Before puncturing the lesion, flush the needle with 5ml saline, then use a 10 ml syringe in order to replacing the column of air with fluid. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wet suction

The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). Before puncturing the lesion, flush the needle with 5ml saline, then use a 10 ml syringe in order to replacing the column of air with fluid. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.

Intervention Type PROCEDURE

Dry suction

The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). The stylet is removed and a 10 ml air-filled pre-vacuum syringe is attached. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age from 18 to 75 years;
* Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
* Plan to receive EUS-FNB.
* Able to obtained informed consent.

Exclusion Criteria

* Had expected difficulty of endoscope insertion
* That no lesion in the pancreas is identified by EUS
* Use of anticoagulants/antiplatelet drugs that cannot be discontinued.
* Had a bleeding tendency, defined as an international normalized ratio of the prothrombin time \>1.5 or a platelet count \<50,000 cells/mL
* Other medical conditions that render the patient an unsuitable candidate for EUS-FNB.
* Vulnerable groups such as pregnant women or patients with mental disorders;
* Patients unable to understand and/or read the consent form.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No