An interventional study of Endoscopic ultrasound guided fine needle biopsy in Solid Tumor, sponsored by Texas Tech University Health Sciences Center, El Paso. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Texas Tech University Health Sciences Center, El Paso · Not applicable, Interventional, and Diagnostic
The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies.
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.
Exclusion Criteria:
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique
Procedure: Endoscopic ultrasound guided fine needle biopsy
This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique
Procedure: Endoscopic ultrasound guided fine needle biopsy
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique
Procedure: 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
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
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
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
The study was terminated early given the difficulty we experienced enrolling patients.
| Milestone | Wet Suction | Dry Suction | Slow Pull |
|---|---|---|---|
| Started | 17 | 20 | 18 |
| Completed | 17 | 20 | 18 |
| Not completed | 0 | 0 | 0 |
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
| units on a scale | Wet Suction | Dry Suction | Slow Pull |
|---|---|---|---|
| Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score | 2.94 ± 0.75 | 3.55 ± 0.76 | 3.28 ± 0.89 |
This is based on the following scale 1. Blood present 2. Blood clots present
| participants | Wet Suction | Dry Suction | Slow Pull |
|---|---|---|---|
| Blood present | 17 | 19 | 18 |
| Blood clot present | 0 | 1 | 0 |
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.
| participants | Wet Suction | Dry Suction | Slow Pull |
|---|---|---|---|
| Diagnostic pass 1 | 6 | 11 | 7 |
| Diagnostic pass 2 | 7 | 5 | 4 |
| Diagnostic pass 3 | 3 | 3 | 6 |
| Diagnostic pass 4 | 1 | 0 | 0 |
| Diagnostic pass 5 | 0 | 1 | 0 |
| Diagnostic pass 6 | 0 | 0 | 1 |
Collected over 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wet Suction | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Dry Suction | 0/20 (0%) | 0/20 (0%) | 3/20 (15%) |
| Slow Pull | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Event | Wet Suction | Dry Suction | Slow Pull |
|---|---|---|---|
| BleedingGastrointestinal disorders | 0/17 | 3/20 | 0/18 |
| Age, Continuous(years) | Wet Suction | Dry Suction | Slow Pull | Total |
|---|---|---|---|---|
| Mean | 69 ± 13 | 64 ± 14 | 66 ± 10 | 66 ± 13 |
| Sex: Female, Male(Participants) | Wet Suction | Dry Suction | Slow Pull | Total |
|---|---|---|---|---|
| Female | 10 | 7 | 6 | 23 |
| Male | 7 | 13 | 12 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Wet Suction | Dry Suction | Slow Pull | Total |
|---|---|---|---|---|
| Hispanic or Latino | 13 | 17 | 15 | 45 |
| Not Hispanic or Latino | 4 | 3 | 3 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Wet Suction | Dry Suction | Slow Pull | Total |
|---|---|---|---|---|
| United States | 17 | 20 | 18 | 55 |
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Texas Tech University Health Sciences Center, El Paso