Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device

Huazhong University of Science and Technology

Status: Unknown

Conditions: Pancreas Neoplasms

Treatments: Device: Using 20G FNB, the first pass is SP; Device: Using 20G FNB, the first pass is MWST; Device: Using 22G FNB, the first pass is MWST; Device: Using 22G FNB, the first pass is SP

Study type: Interventional

Funder types: Other

Identifiers

NCT03803930

FNB20

Details and patient eligibility

About

The purpose of this study is to compare the diagnosis accuracy of 22G EUS Procore fine needle biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic lesions.

Full description

This is a single-blind, randomized, controlled trial. One thousand two hundred and twenty four patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to 4 arms. For arm A1 which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is slow pull(SP)-modified wet suction technique(MWST)-slow pull(SP)-modified wet suction technique(MWST). For arm A2 with 22G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. For arm B1 with 20G EUS Procore fine needle biopsy device, the pass sequence is SP-MWST-SP-MWST. For arm B2 with 20G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. All procedures will be performed by experienced echoendoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.

Enrollment: 1,224 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >18 years old,<85 years old;
2. Gender: Male or Female;
3. Presence solid occupying pancreatic lesions (the diameter>1cm);
4. Must be able to receive examinations in the research center;
5. Must be able to sign the informed consent.

Exclusion criteria

1. Hemoglobin≤8.0 g/dl;
2. Pregnant women;
3. Coagulation disorders;
4. Took anticoagulants such as aspirin, warfarin in the latest week;
5. Acute pancreatitis in the past two weeks;
6. Cardiopulmonary dysfunction;
7. Cannot sign the informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

1,224 participants in 4 patient groups

Arm 22G+SP

Other group

Description:

Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.

Treatment:

Device: Using 22G FNB, the first pass is SP

Arm 22G+MWST

Other group

Description:

Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.

Treatment:

Device: Using 22G FNB, the first pass is MWST

Arm 20G+SP

Other group

Description:

Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.

Treatment:

Device: Using 20G FNB, the first pass is SP

Arm 20G+MWST

Other group

Description:

Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.

Treatment:

Device: Using 20G FNB, the first pass is MWST