Solid TumorNCT03264092
Comparison of Three Tissue Acquiring Techniques During EUS Guided Biopsies of Solid Tumors.
A study testing Endoscopic ultrasound guided fine needle biopsy in people with Solid Tumor, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Endoscopic ultrasound guided fine needle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18-80 years old
- Sex: male or female
- 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.
- Patients who are able to give consent
Who cannot join
- Pregnant female
- Coagulation disorders (platelets < 50,000/mm3, INR > 2)
- Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure.
- Cardiorespiratory dysfunction that precludes sedation.
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech university Health Sciences Center El Paso
El Paso, Texas, 79905
About this study
Official title: Comparison of Three Different Tissue Acquisition Techniques During Endoscopic Ultrasound-guide Fine Needle Biopsies of Solid Tumors: A Randomized Single Blind Clinical Trial.
The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- Endoscopic ultrasound guided fine needle biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound guided fine needle biopsyProcedure or surgery
Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
| Study group | Role | What they receive |
|---|---|---|
| Wet suction | Experimental | This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique Receives: Procedure: Endoscopic ultrasound guided fine needle biopsy |
| Dry suction | Experimental | This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique Receives: Procedure: Endoscopic ultrasound guided fine needle biopsy |
| Slow pull | Experimental | This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique Receives: Procedure: Endoscopic ultrasound guided fine needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score
0: inadequate
- limited cytological dx
- adquate cytological dx
- limited histological dx
- adequate histological dx with low quality
- adequate histological dx with high quality
Measured: 2 hours
Secondary outcomes (2)
Blood Contamination Score of Each Specimen Obtained
This is based on the following scale
- Blood present
- Blood clots present
Measured: 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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start11 Sep 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: Preliminary analysis of the results showed no statistically significant difference
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Mendoza-Ladd, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Antonio Mendoza Ladd, MD, Principal investigator, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264092
- Sponsor's protocol ID
- E17118
- Status last verified
- Mar 2021
- First submitted
- 23 Aug 2017
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yamao K, Sawaki A, Mizuno N, Shimizu Y, Yatabe Y, Koshikawa T. Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB): past, present, and future. J Gastroenterol. 2005 Nov;40(11):1013-23. doi: 10.1007/s00535-005-1717-6.
PubMed 16322944Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.
PubMed 19117242Mendoza Ladd A, Casner N, Cherukuri SV, Garcia C, Padilla O, Dwivedi A, Hakim N. Fine Needle Biopsies of Solid Pancreatic Lesions: Tissue Acquisition Technique and Needle Design Do Not Impact Specimen Adequacy. Dig Dis Sci. 2022 Sep;67(9):4549-4556. doi: 10.1007/s10620-021-07316-4. Epub 2021 Dec 2.
PubMed 34859313
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Tissue Acquisition Techniques During Endoscopic Ultrasound-guide Fine Needle Biopsies of Solid Tumors: A Randomized Single Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT03264092
- Acronym / sponsor ID
- E17118
- Conditions
- Solid Tumor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary analysis of the results showed no statistically significant difference
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Posted 1 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wet suction | Experimental | Procedure: Endoscopic ultrasound guided fine needle biopsyThis arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique |
| Dry suction | Experimental | Procedure: Endoscopic ultrasound guided fine needle biopsyThis arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique |
| Slow pull | Experimental | Procedure: Endoscopic ultrasound guided fine needle biopsyThis arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages between 18-80 years old
- Sex: male or female
- 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.
- Patients who are able to give consent
Key exclusion criteria (5 listed)
- Pregnant female
- Coagulation disorders (platelets < 50,000/mm3, INR > 2)
- Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure.
- Cardiorespiratory dysfunction that precludes sedation.
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound guided fine needle biopsyUsing the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance | Procedure or surgery | Dry suction, Slow pull, Wet suction |
Primary outcome
Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score
Time frame: 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
2 secondary outcomes
Blood Contamination Score of Each Specimen Obtained
Time frame: 2 hours
Number of Participants Stratified Per the Number of Diagnostic Passes Required
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16322944Yamao K, Sawaki A, Mizuno N, Shimizu Y, Yatabe Y, Koshikawa T. Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB): past, present, and future. J Gastroenterol. 2005 Nov;40(11):1013-23. doi: 10.1007/s00535-005-1717-6.
- Background: PubMed 19117242Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.
- Derived from this study: PubMed 34859313Mendoza Ladd A, Casner N, Cherukuri SV, Garcia C, Padilla O, Dwivedi A, Hakim N. Fine Needle Biopsies of Solid Pancreatic Lesions: Tissue Acquisition Technique and Needle Design Do Not Impact Specimen Adequacy. Dig Dis Sci. 2022 Sep;67(9):4549-4556. doi: 10.1007/s10620-021-07316-4. Epub 2021 Dec 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Mendoza Ladd, MD principal investigator
Texas Tech University Health Sciences Center, El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound guided fine needle biopsy in people with Solid Tumor, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264092, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.