NCT05549856

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 18, 2022

Last Update Submit

September 21, 2022

Conditions

Solid Pancreatic LesionsEUS-FNB

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy

    compare the rate of diagnostic accuracy of EUS- FNB using the two different suction techniques (dry suction and wet suction) in patients with solid pancreatic lesions.

    12 months

Secondary Outcomes (5)

  • Samples tissue integrity

    12 months

  • Samples cellularity

    12 months

  • the diagnostic in relation to the number of needle passes

    12 months

  • Time (minutes) of the procedures with dry suction and wet suction

    12 months

  • Percentage of procedure related adverse events [Safety]

    24 months

Study Arms (2)

Dry suction group

EXPERIMENTAL

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

Procedure: Dry suction

Wet suction group

ACTIVE COMPARATOR

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

Procedure: Wet suction

Interventions

Wet suctionPROCEDURE

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.

Wet suction group
Dry suctionPROCEDURE

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.

Dry suction group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Xu S, Guo J, Qin M, Meng Y, Xie F, Qiao W, Hu H, Peng P, Rownoak J, Heng S, Ung F, Ye Y, Wang J, Li W, Zou Y, Zou L, Huang S, Liu S, Wang J, Yao J, Li Y. Dry Suction Versus Wet Suction of Endoscopic Ultrasound-Guided Fine-Needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Multicenter Randomized Controlled Noninferiority Trial. Am J Gastroenterol. 2025 Nov 1;120(11):2529-2537. doi: 10.14309/ajg.0000000000003389. Epub 2025 Feb 27.

    PMID: 40019152DERIVED

  • Xu S, Wang J, Guo J, Xie F, Qiao W, Meng Y, Peng P, Hu H, Huang Y, Liu S, Qin M, Yao J, Li Y. Dry suction versus wet suction technique of endoscopic ultrasound-guided fine-needle biopsy for diagnosis of solid pancreatic lesions: study protocol of a multicenter randomized controlled non-inferiority trial. Trials. 2023 Dec 13;24(1):805. doi: 10.1186/s13063-023-07842-8.

    PMID: 38093381DERIVED

Study Officials

  • Li Yue, Doctor

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yue, Doctor

CONTACT

+86 15975537291liyue_1989919@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2022

First Posted

September 22, 2022

Study Start

September 1, 2022

Primary Completion

December 1, 2023

Study Completion

February 1, 2025

Last Updated

September 23, 2022

Record last verified: 2022-09