Solid Tumor
Conditions
Brief summary
The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies.
Detailed description
Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has been used since 1990's for the diagnosis and staging of esophageal, gastric, duodenal, pancreatobiliary, rectal mediastinal lesions and intra-abdominal lymphadenopathy. Studies have shown a variable range of specimen adequacy when performing pancreatic biopsies with the standard fine needle aspiration (FNA) needles with this modality. There are several factors that affect the overall diagnostic yield of this procedure, such as endosonographer experience, presence of cytopathologist during the procedure, the needle diameter and the number of passes. In this study we will compare the yield of recently available fine biopsy needles (FNB) using three different techniques to obtain samples from solid lesions. The three techniques to be compared in this study are: stylet slow pull (SP) vs dry suction (DS) vs wet suction (WS). wall cells. In the suction technique the stylet of the needle can be left in place or removed before puncturing the lesion. Once the needle is inside the target, negative pressure is applied through a 10 or 20 cc syringe connected to the needle. The wet suction technique consists of flushing of the needle with 5 ml of saline solution to replace the column of air within the lumen of needle with saline solution before needle aspiration. Once the needle is flushed, negative pressure is applied with a 10 or 20 cc syringe connected to the needle. In the slow pull technique, the stylet is left in place in the needle and is slightly retracted prior to puncturing the lesion. Once the needle is inside the target, the stylet is pushed completely into the needle to remove any contaminant cells and several back and forth movements are done while slowly withdrawing the stylet.
Interventions
PROCEDUREEndoscopic 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
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Ages between 18-80 years old 2. Sex: male or female 3. 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. 4. Patients who are able to give consent
Exclusion criteria
1. Pregnant female 2. Coagulation disorders (platelets \< 50,000/mm3, INR \> 2) 3. Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure. 4. Cardiorespiratory dysfunction that precludes sedation. 5. Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score | 2 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Contamination Score of Each Specimen Obtained | 2 hours | This is based on the following scale 1. Blood present 2. Blood clots present |
| Number of Participants Stratified Per the Number of Diagnostic Passes Required | 2 hours | 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. |
Countries
United States
Participant flow
Recruitment details
The study was terminated early given the difficulty we experienced enrolling patients.
Participants by arm
| Arm | Count |
|---|---|
| Wet Suction 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 | 17 |
| Dry Suction 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 | 20 |
| Slow Pull 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 | 18 |
| Total | 55 |
Baseline characteristics
| Characteristic | Wet Suction | Dry Suction | Slow Pull | Total |
|---|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 13 | 64 years STANDARD_DEVIATION 14 | 66 years STANDARD_DEVIATION 10 | 66 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 17 Participants | 15 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 3 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 17 participants | 20 participants | 18 participants | 55 participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 6 Participants | 23 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 12 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 20 | 0 / 18 |
| other Total, other adverse events | 0 / 17 | 3 / 20 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 | 0 / 18 |
Outcome results
Primary
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
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wet Suction | Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score | 2.94 units on a scale | Standard Deviation 0.75 |
| Dry Suction | Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score | 3.55 units on a scale | Standard Deviation 0.76 |
| Slow Pull | Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score | 3.28 units on a scale | Standard Deviation 0.89 |
p-value: 0.18Fisher Exact
Secondary
Blood Contamination Score of Each Specimen Obtained
This is based on the following scale 1. Blood present 2. Blood clots present
Time frame: 2 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Wet Suction | Blood Contamination Score of Each Specimen Obtained | Blood present | 17 participants |
| Wet Suction | Blood Contamination Score of Each Specimen Obtained | Blood clot present | 0 participants |
| Dry Suction | Blood Contamination Score of Each Specimen Obtained | Blood present | 19 participants |
| Dry Suction | Blood Contamination Score of Each Specimen Obtained | Blood clot present | 1 participants |
| Slow Pull | Blood Contamination Score of Each Specimen Obtained | Blood present | 18 participants |
| Slow Pull | Blood Contamination Score of Each Specimen Obtained | Blood clot present | 0 participants |
p-value: 0.41Fisher Exact
Secondary
Number of Participants Stratified Per the Number of Diagnostic Passes Required
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.
Time frame: 2 hours
Population: Diagnostic passes 4 and above were considered outside of protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Wet Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 1 | 6 participants |
| Wet Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 2 | 7 participants |
| Wet Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 3 | 3 participants |
| Wet Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 4 | 1 participants |
| Wet Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 5 | 0 participants |
| Wet Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 6 | 0 participants |
| Dry Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 6 | 0 participants |
| Dry Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 1 | 11 participants |
| Dry Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 4 | 0 participants |
| Dry Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 5 | 1 participants |
| Dry Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 2 | 5 participants |
| Dry Suction | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 3 | 3 participants |
| Slow Pull | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 2 | 4 participants |
| Slow Pull | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 3 | 6 participants |
| Slow Pull | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 6 | 1 participants |
| Slow Pull | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 4 | 0 participants |
| Slow Pull | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 1 | 7 participants |
| Slow Pull | Number of Participants Stratified Per the Number of Diagnostic Passes Required | Diagnostic pass 5 | 0 participants |
p-value: 0.45Fisher Exact