NCT02909530

Brief Summary

Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a sensitivity of 64%-95% and an accuracy of 78%-94% still very low. The EUS-FNB of pancreatic masses is usually performed with a 22-gauge biopsy needle. The small diameter of the needle is usually responsible for the low yield of tissue samples for histopathological examination. The 19-gauge needles help to overcome the limitations of a 22-gauge needle by acquiring a larger amount of cellular material. Thus, performing EUS-FNB with a 19-gauge needle can maximize tissue acquisition and sample adequacy, which is important for appropriate diagnosis. Contrariwise, the technical success rate for sample retrieval in patients with pancreatic head lesions is significantly lower using the 19-gauge compared to the 22-gauge needle. This is attributable to the technical difficulty to push the needle out of the endoscope in the duodenum. Since about 60% of pancreatic cancers are located in the head region, it is therefore particularly important to improve technical success in these cases. The new 19-gauge biopsy needle "Olympus EZ Shot3 Plus" is more flexible than common biopsy needles such as "EZ Shot2" and should therefore provide improved access to regions like pancreatic head. The aim of this multicenter prospective randomized crossover study is to compare those two needles during EUS-FNB of solid pancreatic masses. Therefore this study will enroll 40 patients in five German centers with solid pancreatic masses and consecutive indication for EUS-FNB. Both needles will be used in each patient following a predetermined random order. Primary endpoint is the correct histological diagnosis of the mass assessed by each needle. Technical failure is regarded as a negative histological diagnosis. Secondary endpoints include a comparison of technical failure using each needle, histological quality, duration of procedure and rate of adverse events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

4 active sites

Status
completed

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, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

September 7, 2016

Last Update Submit

February 19, 2019

Conditions

Pancreatic Neoplasms

Keywords

Endoscopic ultrasound-guided fine needle biopsyOlympus EZ Shot 3PlusOlympus EZ Shot 2

Outcome Measures

Primary Outcomes (1)

  • Correct histological diagnosis of the mass assessed by each needle

    Correct histological diagnosis of the mass assessed by each needle compared to gold standard. Gold standard is primarily positive histology, followed by diagnosis made due to additional methods to assess for malignancy (ultrasound, CT, ERCP, surgically retrieved specimen).

    6 months

Secondary Outcomes (5)

  • technical failure (inability to push the EUS-FNB needle out the endoscope to perform puncture)

    Day one

  • histological quality of the specimen retrieved (visual analog scale)

    24 months

  • histological quality of the specimen retrieved (over all satisfaction)

    24 months

  • Duration of procedure

    Day one

  • Adverse events

    24 hours

Study Arms (2)

First pass EZ Shot 3Plus then EZ Shot 2

ACTIVE COMPARATOR

Olympus EZ Shot 3Plus will be used to puncture the mass first (Intervention EUS-FNB with EZ Shot 3Plus first), then the 19G and EZ Shot 2 will be used to puncture the pancreatic mass.

Device: EUS-FNB with EZ Shot 3Plus first

First pass EZ Shot 2 then EZ Shot 3Plus

ACTIVE COMPARATOR

Olympus EZ Shot 2 will be used to puncture the mass first (Intervention EUS-FNB with EZ Shot 2 19G first), then the EZ Shot 3Plus will be used to puncture the pancreatic mass.

Device: EUS-FNB with EZ Shot 2 19G first

Interventions

EUS-FNB with EZ Shot 3Plus firstDEVICE

Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first.

First pass EZ Shot 3Plus then EZ Shot 2
EUS-FNB with EZ Shot 2 19G firstDEVICE

Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first.

First pass EZ Shot 2 then EZ Shot 3Plus

Eligibility Criteria

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

You may qualify if:

  • solid pancreatic mass and consecutive indication for EUS-FNB

You may not qualify if:

  • incapacity to give informed consent
  • Haemorrhagic disease, disorder of hemostasis and coagulation (PT \<60%, PTT\> 42 sec. and platelets \<60000/µL)
  • oral anticoagulants
  • dual antiplatelet therapy with thienopyridines (e.g. clopidogrel)
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Israelitisches Krankenhaus Hamburg

Hamburg, 22297, Germany

Location

Niel Stensen Kliniken Marienhospital Osnabrück

Osnabrück, 49074, Germany

Location

Klinikum Stuttgart, Katharinenhospital

Stuttgart, 70174, Germany

Location

University Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

  • Hann A, Epp S, Veits L, Rosien U, Siegel J, Moschler O, Bohle W, Meining A. Multicenter, randomized comparison of the diagnostic accuracy of 19-gauge stainless steel and nitinol-based needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses. United European Gastroenterol J. 2020 Apr;8(3):314-320. doi: 10.1177/2050640619887580. Epub 2019 Nov 7.

    PMID: 32213013DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Alexander Meining

    University Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Alexander Meining

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 21, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)