NCT04100941

Brief Summary

There are many factors that can affect the diagnostic yield of EUS-FNA, including lesion factors, the endoscoist experience, the needle size, the number of needle passes, and the suction technique. since diagnostic efficacy of different suction techniques for EUS-FNB is still uncertain, thus we decided to compare the diagnostic efficacy of three common methods: the 10 ml standard negative pressure, slow pull and wet suction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

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

June 10, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

September 23, 2019

Last Update Submit

September 23, 2019

Conditions

Pancreatic Mass

Outcome Measures

Primary Outcomes (3)

  • diagnostic accuracy of each individual technique

    The results are compared with the gold standard and calculated the accuracy

    1 year

  • diagnostic sensitivity of each individual technique

    The results are compared with the gold standard and calculated the sensitivity

    1 year

  • specificity of each individual technique

    The results are compared with the gold standard and calculated the specificity

    1 year

Secondary Outcomes (4)

  • adverse event rate of each individual technique

    1 year

  • adequacy of specimens obtained by each individual technique

    1 year

  • cellularity

    1 year

  • blood contamination

    1 year

Study Arms (3)

standard suction

EXPERIMENTAL

This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the standard suction technique with 10ml negative pressure

Diagnostic Test: standard suction

slow pull

EXPERIMENTAL

This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique

Diagnostic Test: slow pull

wet suction

EXPERIMENTAL

This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique

Diagnostic Test: wet suction

Interventions

standard suctionDIAGNOSTIC_TEST

After the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured.

standard suction
slow pullDIAGNOSTIC_TEST

After the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.

slow pull
wet suctionDIAGNOSTIC_TEST

After removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.

wet suction

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-75 years,male or female
  • diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
  • lesion diameter larger than 1 cm
  • signed informed consent letter

You may not qualify if:

  • pregnant female
  • Pancreatic cystic lesions
  • Anticoagulant/antiplatelet therapy cannot be suspended
  • unable or refuse to provide informed consent
  • Coagulopathy (platelet count \< 50× 103/μL,international normalized ratio \> 1.5)
  • Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
  • with history of mental disease
  • other medical conditions that are not suitable for EUS-FNB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

RECRUITING

Study Officials

  • Zhao-shen Li, M.D.,Ph.D.

    Changhai Hospital

    STUDY CHAIR

Central Study Contacts

Wei Zhou, M.D.

CONTACT

+8618021009362zhou_wei0012@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of the Gastroenterology

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 24, 2019

Study Start

June 10, 2019

Primary Completion

May 30, 2020

Study Completion

November 30, 2020

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)