NCT03264092

Brief Summary

The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

3.1 years

First QC Date

August 23, 2017

Results QC Date

February 8, 2021

Last Update Submit

March 3, 2021

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score

    0: inadequate 1. limited cytological dx 2. adquate cytological dx 3. limited histological dx 4. adequate histological dx with low quality 5. adequate histological dx with high quality

    2 hours

Secondary Outcomes (2)

  • Blood Contamination Score of Each Specimen Obtained

    2 hours

  • Number of Participants Stratified Per the Number of Diagnostic Passes Required

    2 hours

Study Arms (3)

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

Procedure: Endoscopic ultrasound guided fine needle biopsy

Dry suction

EXPERIMENTAL

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

Procedure: Endoscopic ultrasound guided fine needle biopsy

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

Procedure: Endoscopic ultrasound guided fine needle biopsy

Interventions

Endoscopic ultrasound guided fine needle biopsyPROCEDURE

Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance

Dry suctionSlow pullWet suction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages between 18-80 years old
  • Sex: male or female
  • Patients who require EUS and tissue sampling of solid solid lesions (size \>1 cm) anywhere in the following locations: lymph nodes, stomach, esophagus, colon, small intestine, pancreas, liver, spleen or kidney.
  • Patients who are able to give consent

You may not qualify if:

  • Pregnant female
  • Coagulation disorders (platelets \< 50,000/mm3, INR \> 2)
  • Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure.
  • Cardiorespiratory dysfunction that precludes sedation.
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech university Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

Related Publications (3)

  • Yamao K, Sawaki A, Mizuno N, Shimizu Y, Yatabe Y, Koshikawa T. Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB): past, present, and future. J Gastroenterol. 2005 Nov;40(11):1013-23. doi: 10.1007/s00535-005-1717-6.

    PMID: 16322944BACKGROUND

  • Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.

    PMID: 19117242BACKGROUND

  • Mendoza Ladd A, Casner N, Cherukuri SV, Garcia C, Padilla O, Dwivedi A, Hakim N. Fine Needle Biopsies of Solid Pancreatic Lesions: Tissue Acquisition Technique and Needle Design Do Not Impact Specimen Adequacy. Dig Dis Sci. 2022 Sep;67(9):4549-4556. doi: 10.1007/s10620-021-07316-4. Epub 2021 Dec 2.

    PMID: 34859313DERIVED

Results Point of Contact

Title
Dr. Antonio Mendoza Ladd
Organization
Texas Tech University Health Sciences Center
antonio.mendoza-ladd@ttuhsc.edu
9152154678

Study Officials

  • Antonio Mendoza Ladd, MD

    Texas Tech University Health Sciences Center, El Paso

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 28, 2017

Study Start

September 11, 2017

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

April 1, 2021

Results First Posted

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)