NCT07023549

The 22G Franseen Needle Combined With Different Aspiration Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy

Comparing the Sample Quality of 22G Franseen Needle Combined With Different Aspiration Techniques in Endoscopic Ultrasound-Guided Fine-Needle Biopsy of Pancreatic Solid Lesions: A Randomized Controlled Multicenter Clinical Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Franseen needle combined with three different suction techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.

Detailed description

Patients who met the inclusion criteria of this trial and did not meet the exclusion criteria were randomly divided into six groups according to the crossover grouping design. Samples were collected using a 22G Franseen needle in different suction sequences. The advantages and disadvantages of different suction techniques in terms of sample quality and diagnostic efficacy were compared to further clarify the optimal suction sampling scheme for Endoscopic ultrasound-guided fine-needle biopsy using a 22G Franseen needle.

Conditions

• Pancreatic Diseases

Interventions

Type	Name	Description
PROCEDURE	ABC	Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.
PROCEDURE	ACB	Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.
PROCEDURE	BAC	Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.
PROCEDURE	BCA	Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.
PROCEDURE	CAB	Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.
PROCEDURE	CBA	Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: China