NCT02919553

Brief Summary

The purpose of the study is to compare two particular techniques of tissue (capillary vs wet-suction techniques) sampling during endoscopic ultrasound guided fine needle aspiration/biopsy (EUS-FNA/FNB) of a solid lesion to determine the diagnostic yield and procedure logistics (e.g. procedure time).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Typical duration for not_applicable pancreatic-cancer

Status
withdrawn

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 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

3.9 years

First QC Date

August 28, 2016

Last Update Submit

October 16, 2020

Conditions

Pancreatic CancerStomach Neoplasms

Keywords

endoscopic ultrasoundwet-suction techniquecapillary techniquefine needle aspirationfine needle biopsy

Outcome Measures

Primary Outcomes (1)

  • Rate of core tissue acquisition adequate for histologic analysis.

    4 weeks

Secondary Outcomes (7)

  • Diagnostic yield will measure the percentage of tissue acquisition cases that matched up with the final diagnosis.

    4 weeks

  • Procedure time

    4 weeks

  • Tissue smear and cell block cellularity will be graded along this scale: Cellularity, graded 0 = no cells, 1 = sparsely cellular, 2 = moderately cellular, and 3 = highly cellular.

    4 weeks

  • Tissue smear and cell block will be assessed of blood contamination with this scale: graded 0 = free of contamination, 1 = contaminated, 2 = highly contaminated, with or without blood clots.

    4 weeks

  • Tissue smear and cell block will be assessed of insertion tissue contamination with this scale: graded 0 = free of contamination, 1 = contaminated, 2 = highly contaminated.

    4 weeks

  • +2 more secondary outcomes

Study Arms (2)

modified wet-suction technique

EXPERIMENTAL

Patients in this arm will undergo the modified wet-suction technique. Details in the study description section. After sufficient sampling of the lesion, the needle will be removed and the specimen will be collected.

Procedure: modified wet-suction technique

Capillary "slow pull" technique

ACTIVE COMPARATOR

Patients in this arm will undergo the Capillary "slow pull" technique which will include moving the needle to-and-fro into the lesion. Subsequently the needle will be removed and the specimen will be collected.

Procedure: Capillary "slow pull" technique

Interventions

modified wet-suction techniquePROCEDURE

Normal saline will be present in this needle, and once in the lesion of interest the suction will be re-established and the needle will be moved in a to-and-fro motion to collect the sample of interest. Then the sample will be collected.

modified wet-suction technique
Capillary "slow pull" techniquePROCEDURE

The needle will be introduced into the lesion of interest and using the to-and-fro motion, collect the sample. The needle will then be withdrawn and the sample will then be collected.

Capillary "slow pull" technique

Eligibility Criteria

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

You may qualify if:

  • All adult patients (greater than 18 years of age) who are referred for EUS guided sampling of solid lesions.

You may not qualify if:

  • Any patients with contraindication to EUS- fine-needle aspiration/fine-needle biopsy (FNA/B), including those on anti-platelet or on anti-coagulation therapy, or with congenital disorders.
  • Patients with cystic lesions or submucosal lesions will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Wani S, Muthusamy VR, Komanduri S. EUS-guided tissue acquisition: an evidence-based approach (with videos). Gastrointest Endosc. 2014 Dec;80(6):939-59.e7. doi: 10.1016/j.gie.2014.07.066. No abstract available.

    PMID: 25434654BACKGROUND

  • Kim GH, Cho YK, Kim EY, Kim HK, Cho JW, Lee TH, Moon JS; Korean EUS Study Group. Comparison of 22-gauge aspiration needle with 22-gauge biopsy needle in endoscopic ultrasonography-guided subepithelial tumor sampling. Scand J Gastroenterol. 2014 Mar;49(3):347-54. doi: 10.3109/00365521.2013.867361. Epub 2013 Dec 11.

    PMID: 24325591BACKGROUND

  • Krishnan K, Dalal S, Nayar R, Keswani RN, Keefer L, Komanduri S. Rapid on-site evaluation of endoscopic ultrasound core biopsy specimens has excellent specificity and positive predictive value for gastrointestinal lesions. Dig Dis Sci. 2013 Jul;58(7):2007-12. doi: 10.1007/s10620-013-2613-1. Epub 2013 Mar 17.

    PMID: 23504350BACKGROUND

  • Keswani RN, Krishnan K, Wani S, Keefer L, Komanduri S. Addition of Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration and On-Site Cytology to EUS-Guided Fine Needle Biopsy Increases Procedure Time but Not Diagnostic Accuracy. Clin Endosc. 2014 May;47(3):242-7. doi: 10.5946/ce.2014.47.3.242. Epub 2014 May 31.

    PMID: 24944988BACKGROUND

  • Iwashita T, Nakai Y, Samarasena JB, Park DH, Zhang Z, Gu M, Lee JG, Chang KJ. High single-pass diagnostic yield of a new 25-gauge core biopsy needle for EUS-guided FNA biopsy in solid pancreatic lesions. Gastrointest Endosc. 2013 Jun;77(6):909-15. doi: 10.1016/j.gie.2013.01.001. Epub 2013 Feb 20.

    PMID: 23433596BACKGROUND

  • Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.

    PMID: 25733127BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach Diseases

Study Officials

  • Alexander Jahng, M.D

    Loma Linda Univ Medical gastroenterology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterology attending

Study Record Dates

First Submitted

August 28, 2016

First Posted

September 29, 2016

Study Start

January 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share