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Clinical Trial NCT06563232 for Pancreatic Neoplasms, Mediastinal Neoplasms, Abdominal Neoplasm, Excluding Pancreas Neoplasm is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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22G-Adapt Needle Biopsy Versus Fine-needle Aspiration in Endoscopic Ultrasound-guided Sampling of Solid Lesions 656 Randomized

Not yet recruiting
Clinical Trial NCT06563232 is an interventional study for Pancreatic Neoplasms, Mediastinal Neoplasms, Abdominal Neoplasm, Excluding Pancreas Neoplasm and is currently not yet recruiting. Enrollment is planned to begin on September 1, 2024 and continue until the study accrues 656 participants. Led by Huazhong University of Science and Technology, this study is expected to complete by February 1, 2026. The latest data from ClinicalTrials.gov was last updated on August 20, 2024.
Brief Summary
The investigators conduct a multicenter randomized controlled study to evaluate the diagnostic value and safety of 22G Adapt Aspiration puncture needle for histopathology of solid lesions.
Detailed Description
The study subjects are divided into two groups: the EUS-FNA(22G EchoTip Ultra needles) Group and EUS-FNB group(22 Adapt Aspiration).Take the malignant occupying lesion diagnosis accuracy as the research major indicator to compare the EUS-FNB group and EUS-FNA group as optimal efficiency test. Take the class I error a=0.05, class II error β=0.15, power=0.85. Suppose the malignancy diagnosis accuracy is 82%, while that...Show More
Official Title

22G-Adapt Needle Biopsy Versus Fine-needle Aspiration in Endoscopic Ultrasound-guided Sampling of Solid Lesions: a Randomized Controlled Study

Conditions
Pancreatic NeoplasmsMediastinal NeoplasmsAbdominal Neoplasm, Excluding Pancreas Neoplasm
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • FNA vs Adapt FNB
NCT ID Number
NCT06563232
Start Date (Actual)
2024-09-01
Last Update Posted
2024-08-20
Completion Date (Estimated)
2026-02-01
Enrollment (Estimated)
656
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
endoscopic ultrasound
fine-needle aspiration
fine-needle biopsy
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalFNA group
FNA needles adopted to acquire lesion tissues
FNA group
Fine-needle-aspiration (22G EchoTip Ultra Echo-3-22)
ExperimentalAdapt FNB group
Adapt FNB needles adopted to acquire lesion tissues
Adapt FNB group
Fine-needle-biopsy (22G Adapt Aspiration)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The histological diagnostic yields
The investigators' primary outcome measure is to compare the histological diagnostic yields of 22G Adapt Aspiration FNB and FNA puncture needle (22G EchoTip Ultra Echo-3-22) to the solid pancreatic or nonpancreatic lesions compared to conventional FNA puncture needle(22G EchoTip Ultra Echo-3-22) for pancreatic and non-pancreatic solid lesions.
up to 15 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
the histological acquisition yields
Comparing the histological acquisition yields of 22G Adapt Aspiration (EUS-FNB) and Echo-3-22 (EUS-FNA) for solid space-occupying lesions.
up to 15 months
the diagnostic yields of the first pass and the number of subsequent passes
Comparing the diagnostic yields of the first puncture needle and subsequent puncture needles of 22G Adapt Aspiration (EUS-FNB) and Echo-3-22 (EUS-FNA) for solid space-occupying lesions(EUS-FNA) for the number of first and subsequent puncture needles for solid space occupying lesions.
up to 15 months
the cytological diagnosis yields
Comparing the cytological diagnostic yields of 22G Adapt Aspiration (EUS-FNB) and Echo-3-22 (EUS-FNA) for solid space-occupying lesions.
up to 15 months
the complication yields
Comparing the complication rates during and after puncture between 22G Adapt Aspiration (EUS-FNB) and Echo-3-22.
up to 15 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Over 18 years old and under 85 years old;
  • Imaging examinations (MRI, CT, B-ultrasound) reveal the presence of solid masses (with a diameter > 1 cm) within the regions accessible by endoscopic ultrasound in the pancreas, peripancreatic area, liver, adrenal gland, kidney, mediastinum, lung, and gastrointestinal submucosa. Biopsy is necessary for the diagnosis of these lesions;
  • Must be able to receive examinations in the research center;
  • Must be able to sign the informed consent.

  • Hemoglobin ≤8.0 g/dL;
  • Pregnant women;
  • Coagulation disorders (PLT <50,000/mm3,INR > 1.5);
  • Took anticoagulants such as aspirin, warfarin in the latest week;
  • Acute pancreatitis in the past two weeks;
  • inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); refusal or inability to provide an informed consent.
Huazhong University of Science and Technology logoHuazhong University of Science and Technology361 active studies to explore
Study Responsible Party
Bin Cheng, Principal Investigator, prof., Huazhong University of Science and Technology
Study Central Contact
Contact: Bin Cheng, +8613986097542, [email protected]
Contact: Qingxiong Ma, +8613588580316, [email protected]
1 Study Locations in 1 Countries

Hubei

Tongji Hospital, Tongji Medical College, HUST, Wuhan, Hubei, 430030, China
Bin Cheng, Professor, Contact, 86-027-8366-3333, [email protected]
Qingxiong Ma, Contact, +8613588580316, [email protected]