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Trial record 24 of 164 for:    PEMT

Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle (MUCIN)

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ClinicalTrials.gov Identifier: NCT01769248
Recruitment Status : Completed
First Posted : January 16, 2013
Results First Posted : March 18, 2015
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sri Komanduri, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Pancreatic Cancer
Lymphadenopathy
Gastrointestinal Stromal Tumor
Interventions Device: Fine needle aspiration
Device: Fine needle biopsy
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fine Needle Aspiration (FNA) Fine Needle Biopsy (FNB)
Hide Arm/Group Description

fine needle aspiration

Fine needle aspiration: Fine needle aspiration using endoscopic ultrasound-FNA needles. This was the standard of care arm

Fine Needle biopsy

Fine Needle biopsy: FNB, test arm for core biopsies, endoscopic ultrasound-FNB

Period Title: Overall Study
Started 70 70
Participants Who Crossed-over 28 12
Completed 42 58
Not Completed 28 12
Arm/Group Title Fine Needle Aspiration Fine Needle Biopsy Total
Hide Arm/Group Description

fine needle aspiration

Fine needle aspiration: Fine needle aspiration

Fine needle biopsy

Fine needle biopsy: FNB

Total of all reporting groups
Overall Number of Baseline Participants 70 70 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
  71.4%
57
  81.4%
107
  76.4%
>=65 years
20
  28.6%
13
  18.6%
33
  23.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 70 participants 140 participants
63.7  (14.4) 64.1  (14.4) 63.8  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Female
36
  51.4%
30
  42.9%
66
  47.1%
Male
34
  48.6%
40
  57.1%
74
  52.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants 70 participants 140 participants
70 70 140
1.Primary Outcome
Title Diagnostic Yield of EUS-FNB and EUS-FNA
Hide Description The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fine Needle Aspiration Fine Needle Biopsy
Hide Arm/Group Description:

fine needle aspiration

Fine needle aspiration: Fine needle aspiration

Fine needle biopsy

Fine needle biopsy: FNB

Overall Number of Participants Analyzed 70 70
Measure Type: Number
Unit of Measure: percentage of patients
67.1 90
2.Secondary Outcome
Title Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB
Hide Description The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with pancreatic and non-pancreatic lesions receiving EUS-FNA and EUS-FNB.
Arm/Group Title Fine Needle Aspiration Fine Needle Biopsy
Hide Arm/Group Description:

fine needle aspiration

Fine needle aspiration: Fine needle aspiration

Fine needle biopsy

Fine needle biopsy: FNB

Overall Number of Participants Analyzed 70 70
Measure Type: Number
Unit of Measure: percentage of participants
60.0 82.8
3.Secondary Outcome
Title Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)
Hide Description As above. Crossover to FNA or FNB occurs after 3 passes without adequate material
Time Frame 1 yr
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving alternative tissue acquisition method when initial three passes with either EUS-FNA or EUS-FNB failed to provide an adequate specimen.
Arm/Group Title Fine Needle Aspiration to Fine Needle Biopsy Fine Needle Biopsy to Fine Needle Aspiration
Hide Arm/Group Description:

fine needle aspiration to fine needle biopsy

EUS-FNA to EUS-FNB

Fine needle biopsy to fine needle aspiration

EUS-FNB to EUS-FNA

Overall Number of Participants Analyzed 28 12
Measure Type: Number
Unit of Measure: percentage of participants
96.4 41.7
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fine Needle Aspiration Fine Needle Biopsy
Hide Arm/Group Description Fine needle aspiration: Fine needle aspiration

Fine needle biopsy

Fine needle biopsy: FNB

All-Cause Mortality
Fine Needle Aspiration Fine Needle Biopsy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fine Needle Aspiration Fine Needle Biopsy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fine Needle Aspiration Fine Needle Biopsy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Srinadh Komanduri
Organization: Northwestern University
Phone: 312-695-0484
Responsible Party: Sri Komanduri, Northwestern University
ClinicalTrials.gov Identifier: NCT01769248     History of Changes
Other Study ID Numbers: FNAFNBmucin
First Submitted: January 10, 2013
First Posted: January 16, 2013
Results First Submitted: March 5, 2015
Results First Posted: March 18, 2015
Last Update Posted: January 18, 2018