Trial Outcomes & Findings for Comparison of Three Tissue Acquiring Techniques During EUS Guided Biopsies of Solid Tumors. (NCT NCT03264092)
NCT ID: NCT03264092
Last Updated: 2021-04-01
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
2 hours
Results posted on
2021-04-01
Participant Flow
The study was terminated early given the difficulty we experienced enrolling patients.
Participant milestones
| Measure |
Wet Suction
This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
|
Dry Suction
This arm included all the patients that got and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
|
Slow Pull
This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=17
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
18
|
|
Overall Study
COMPLETED
|
17
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Three Tissue Acquiring Techniques During EUS Guided Biopsies of Solid Tumors.
Baseline characteristics by cohort
| Measure |
Wet Suction
n=17 Participants
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
|
Dry Suction
n=20 Participants
This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
|
Slow Pull
n=18 Participants
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique
Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 13 • n=5 Participants
|
64 years
STANDARD_DEVIATION 14 • n=7 Participants
|
66 years
STANDARD_DEVIATION 10 • n=5 Participants
|
66 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
18 participants
n=5 Participants
|
55 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 hours0: 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
Outcome measures
| Measure |
Wet Suction
n=17 Participants
This arm describes the mean cellularity score obtained with the wet suction technique.
|
Dry Suction
n=20 Participants
This arm describes the mean cellularity score obtained with the dry suction technique.
|
Slow Pull
n=18 Participants
This arm describes the mean cellularity score obtained with the slow pull technique.
|
|---|---|---|---|
|
Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score
|
2.94 units on a scale
Standard Deviation 0.75
|
3.55 units on a scale
Standard Deviation 0.76
|
3.28 units on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: 2 hoursThis is based on the following scale 1. Blood present 2. Blood clots present
Outcome measures
| Measure |
Wet Suction
n=17 Participants
This arm describes the mean cellularity score obtained with the wet suction technique.
|
Dry Suction
n=20 Participants
This arm describes the mean cellularity score obtained with the dry suction technique.
|
Slow Pull
n=18 Participants
This arm describes the mean cellularity score obtained with the slow pull technique.
|
|---|---|---|---|
|
Blood Contamination Score of Each Specimen Obtained
Blood present
|
17 participants
|
19 participants
|
18 participants
|
|
Blood Contamination Score of Each Specimen Obtained
Blood clot present
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Diagnostic passes 4 and above were considered outside of protocol
This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol.
Outcome measures
| Measure |
Wet Suction
n=17 Participants
This arm describes the mean cellularity score obtained with the wet suction technique.
|
Dry Suction
n=20 Participants
This arm describes the mean cellularity score obtained with the dry suction technique.
|
Slow Pull
n=18 Participants
This arm describes the mean cellularity score obtained with the slow pull technique.
|
|---|---|---|---|
|
Number of Participants Stratified Per the Number of Diagnostic Passes Required
Diagnostic pass 1
|
6 participants
|
11 participants
|
7 participants
|
|
Number of Participants Stratified Per the Number of Diagnostic Passes Required
Diagnostic pass 2
|
7 participants
|
5 participants
|
4 participants
|
|
Number of Participants Stratified Per the Number of Diagnostic Passes Required
Diagnostic pass 3
|
3 participants
|
3 participants
|
6 participants
|
|
Number of Participants Stratified Per the Number of Diagnostic Passes Required
Diagnostic pass 4
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Stratified Per the Number of Diagnostic Passes Required
Diagnostic pass 5
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Stratified Per the Number of Diagnostic Passes Required
Diagnostic pass 6
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Wet Suction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dry Suction
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Slow Pull
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Wet Suction
n=17 participants at risk
This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17 subjects
|
Dry Suction
n=20 participants at risk
This arm included all the patients that got and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20 subjects
|
Slow Pull
n=18 participants at risk
This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=18 subjects
\\
|
|---|---|---|---|
|
Gastrointestinal disorders
Bleeding
|
0.00%
0/17 • 2 hours
Adverse events evaluated in this study were: bleeding, bowel perforation and hemodynamic instability. The definitions of these adverse events are similar to the ones established by clinicaltrials.gov
|
15.0%
3/20 • Number of events 3 • 2 hours
Adverse events evaluated in this study were: bleeding, bowel perforation and hemodynamic instability. The definitions of these adverse events are similar to the ones established by clinicaltrials.gov
|
0.00%
0/18 • 2 hours
Adverse events evaluated in this study were: bleeding, bowel perforation and hemodynamic instability. The definitions of these adverse events are similar to the ones established by clinicaltrials.gov
|
Additional Information
Dr. Antonio Mendoza Ladd
Texas Tech University Health Sciences Center
Phone: 9152154678
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place