Digestive CancerEUSNCT03460197

Comparison Between Two Tissue Acquisition Techniques by Endoscopic Ultrasound. (EUS)

An observational study of Digestive Cancer, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Digestive Cancer
What is being tested?: Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Type of treatment: Surgery or procedure
How many people: 30 participants
Where: 1 siteMexico
Study dates: 20 Apr 2018to 20 Jul 2018
Phase: Observational
Are there results?: None posted in the registry

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

Study population: Referred to the Endoscopy Department from their corresponding basic health care units within the Mexican Social Security System

Who may be able to join

Low or moderate suspicious of malignancy lesion in pancreas, liver or metastatic lymph nodes
Initial diagnosis according to the characterization by endoscopic ultrasound

Who cannot join

Bleeding
Complications during biopsy procedure
Needed to use procedures other than those contemplated in the study.
Patients who not require endoscopic ultrasound evaluation
Patients who not accept the procedures of the study

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
Mexico City, Mexico City, 06720

Other trials in Mexico

About this study

Official title: Capillarity Versus Wet Technique. Comparison Between Two Methods of Tissue Acquisition Guided by Endoscopic Ultrasound.

There are various techniques to obtain tissue samples by using fine needle guided by endoscopic ultrasound (EUS). These techniques attempt to obtain the most adequate material with the best quantity and quality for analysis. Currently studies that compare the results concerning capillary technique versus wet technique are not available. In this sense, the authors consider necessary to explore both techniques documenting the results that can define which could be the best method so that it can routinely be used in cases of digestive neoplasia.

Read the detailed description

The aim of the study will be compare both techniques guided by endoscopic ultrasound (Capillarity versus Wet) and identify which obtains the best sample quality for histopathology analysis as tissue acquisition method in patients diagnosed with tumors of pancreas, biliary tract, liver or lymph nodes.

The researchers are planning a prospective, pilot study in 30 subjects. All patients will be submitted to both techniques of tissue acquisition (capillarity versus wet) in the same procedure of endoscopic ultrasound. Obtained samples for histopathology analysis will be submitted to a blind examination by two different pathologists.

Conditions: Digestive Cancer
Being tested: Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Keywords: Capillary technique, Wet technique, Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Medical subject headings: Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endoscopic Ultrasound-Guided Fine-Needle AspirationProcedure or surgery
Patients will be submitted to both techniques of tissue acquisition in the same procedure of endoscopic ultrasound. Capillarity technique, requires not remove the stiletto from the needle until the punctures are done for the biopsy sampling. Wet suction technique, requires saline solution to replace the air column. Samplings will be placed in two different jars, where Jar 1 corresponds to Capillarity Technique sampling and Jar 2 to Wet Technique. Once the sampling preparation is concluded will be send to the Pathology Department to be subsequently blindly analyzed by two independent pathologists, that means they would not be aware of the tissue acquisition method used in each of the microscopic slides to analyze.

What is being measured

The primary outcome is the main question the study is designed to answer.

The classification of Papanicolaou was used for the terminology in pancreatobiliary cytological evaluation of biopsy samples.
I.- Non-diagnostic: Specimen does not provide information about whether the lesion is cystic or solid.
II.- Negative (for malignancy): Specimen has adequate cellularity and / or extracellular material that defines a lesion that is identified by image.
III.- Atypical: There are cells with architectural, nuclear or cytoplasmic that are not consistent with reactive changes. However, these findings are not conclusive to diagnose malignancy or suspected of malignancy.
IV.- Neoplastic: benign and others. Neoplasic benign: Sample has elements of benign neoplasm. Neoplastic others: May be is a premalignant lesion like low-level dysplasia, intermediate or high grade dysplasia or a low grade neoplasm with malignant behavior.
V.- Suspected of malignancy: Cytological characteristics support the Diagnosis of malignancy but quantitatively or qualitatively is not enough to confirm it.
VI.- Positive / malignant: Cytological changes are unequivocal of malignancy.
Measured: 4 months once the study has begun

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201820 Jul 2018

First posted9 Mar 2018
Study start20 Apr 2018
Primary completion20 Jun 2018
Study completion20 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Digestive CancerStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03460197
Sponsor's protocol ID: R-2016-3601-190
Acronym: EUS
Status last verified: Feb 2019
First submitted: 12 Jan 2018
Last updated: 28 Feb 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: This is a pilot study. It means a few patients will be included. We are not subjecting the participants to a higher risk than the endoscopic ultrasound itself and the procedures performed here are usual. The authors will only document the experience.

Publications

Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.
PubMed 25733127
Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.
PubMed 28898917
Lakhtakia S. Complications of diagnostic and therapeutic Endoscopic Ultrasound. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):807-823. doi: 10.1016/j.bpg.2016.10.008. Epub 2016 Oct 28.
PubMed 27931638
Wiersema MJ, Kochman ML, Cramer HM, Tao LC, Wiersema LM. Endosonography-guided real-time fine-needle aspiration biopsy. Gastrointest Endosc. 1994 Nov-Dec;40(6):700-7.
PubMed 7859968
Hedenstrom P, Demir A, Khodakaram K, Nilsson O, Sadik R. EUS-guided reverse bevel fine-needle biopsy sampling and open tip fine-needle aspiration in solid pancreatic lesions - a prospective, comparative study. Scand J Gastroenterol. 2018 Feb;53(2):231-237. doi: 10.1080/00365521.2017.1421704. Epub 2018 Jan 4.
PubMed 29301477
Ang TL, Kwek ABE, Wang LM. Diagnostic Endoscopic Ultrasound: Technique, Current Status and Future Directions. Gut Liver. 2018 Sep 15;12(5):483-496. doi: 10.5009/gnl17348.
PubMed 29291601
Wani S, Muthusamy VR, Komanduri S. EUS-guided tissue acquisition: an evidence-based approach (with videos). Gastrointest Endosc. 2014 Dec;80(6):939-59.e7. doi: 10.1016/j.gie.2014.07.066. No abstract available.
PubMed 25434654
Varadarajulu S, Hasan MK, Bang JY, Hebert-Magee S, Hawes RH. Endoscopic ultrasound-guided tissue acquisition. Dig Endosc. 2014 Jan;26 Suppl 1:62-9. doi: 10.1111/den.12146. Epub 2013 Aug 28.
PubMed 24033879
Jani BS, Rzouq F, Saligram S, Lim D, Rastogi A, Bonino J, Olyaee M. Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Lesions: A Systematic Review of Technical and Procedural Variables. N Am J Med Sci. 2016 Jan;8(1):1-11. doi: 10.4103/1947-2714.175185.
PubMed 27011940
Wang J, Wu X, Yin P, Guo Q, Hou W, Li Y, Wang Y, Cheng B. Comparing endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) versus fine needle biopsy (FNB) in the diagnosis of solid lesions: study protocol for a randomized controlled trial. Trials. 2016 Apr 12;17:198. doi: 10.1186/s13063-016-1316-2.
PubMed 27071386
Iwashita T, Nakai Y, Samarasena JB, Park DH, Zhang Z, Gu M, Lee JG, Chang KJ. High single-pass diagnostic yield of a new 25-gauge core biopsy needle for EUS-guided FNA biopsy in solid pancreatic lesions. Gastrointest Endosc. 2013 Jun;77(6):909-15. doi: 10.1016/j.gie.2013.01.001. Epub 2013 Feb 20.
PubMed 23433596
Bang JY, Hawes RH, Varadarajulu S. EUS-guided tissue acquisition: things are not always what they seem. Gastrointest Endosc. 2015 May;81(5):1300-1. doi: 10.1016/j.gie.2014.12.044. No abstract available.
PubMed 25864902
Vilmann P, Seicean A, Saftoiu A. Tips to overcome technical challenges in EUS-guided tissue acquisition. Gastrointest Endosc Clin N Am. 2014 Jan;24(1):109-24. doi: 10.1016/j.giec.2013.08.009.
PubMed 24215763
Shah JN, Muthusamy VR. Minimizing complications of endoscopic ultrasound and EUS-guided fine needle aspiration. Gastrointest Endosc Clin N Am. 2007 Jan;17(1):129-43, vii-viii. doi: 10.1016/j.giec.2006.10.002.
PubMed 17397780
Yamao K, Ohashi K, Mizutani S, Furukawa T, Watanabe Y, Nakamura T, Suzuki T, Takeda K. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for the diagnosis of digestive diseases. Endoscopy. 1998 Aug;30 Suppl 1:A176-8. doi: 10.1055/s-2007-1001513. No abstract available.
PubMed 9765119

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Digestive Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Capillarity Versus Wet Technique. Comparison Between Two Methods of Tissue Acquisition Guided by Endoscopic Ultrasound.
ClinicalTrials.gov ID: NCT03460197
Acronym / sponsor ID: EUS / R-2016-3601-190
Conditions: Digestive Cancer
Keywords: Capillary technique, Wet technique, Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Instituto Mexicano del Seguro SocialOther government
Study start: 20 Apr 2018 (actual)
Primary completion: 20 Jun 2018 (actual)
Study completion: 20 Jul 2018 (actual)
First posted: 9 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Referred to the Endoscopy Department from their corresponding basic health care units within the Mexican Social Security System

Key inclusion criteria (2 listed)

Low or moderate suspicious of malignancy lesion in pancreas, liver or metastatic lymph nodes
Initial diagnosis according to the characterization by endoscopic ultrasound

Key exclusion criteria (5 listed)

Bleeding
Complications during biopsy procedure
Needed to use procedures other than those contemplated in the study.
Patients who not require endoscopic ultrasound evaluation
Patients who not accept the procedures of the study

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 AspirationPatients will be submitted to both techniques of tissue acquisition in the same procedure of endoscopic ultrasound. Capillarity technique, requires not remove the stiletto from the needle until the punctures are done for the biopsy sampling. Wet suction technique, requires saline solution to replace the air column. Samplings will be placed in two different jars, where Jar 1 corresponds to Capillarity Technique sampling and Jar 2 to Wet Technique. Once the sampling preparation is concluded will be send to the Pathology Department to be subsequently blindly analyzed by two independent pathologists, that means they would not be aware of the tissue acquisition method used in each of the microscopic slides to analyze.	Procedure or surgery	–

Primary outcome

The classification of Papanicolaou was used for the terminology in pancreatobiliary cytological evaluation of biopsy samples.
Time frame: 4 months once the study has begun
I.- Non-diagnostic: Specimen does not provide information about whether the lesion is cystic or solid. II.- Negative (for malignancy): Specimen has adequate cellularity and / or extracellular material that defines a lesion that is identified by image. III.- Atypical: There are cells with architectural, nuclear or cytoplasmic that are not consistent with reactive changes. However, these findings are not conclusive to diagnose malignancy or suspected of malignancy. IV.- Neoplastic: benign and others. Neoplasic benign: Sample has elements of benign neoplasm. Neoplastic others: May be is a premalignant lesion like low-level dysplasia, intermediate or high grade dysplasia or a low grade neoplasm with malignant behavior. V.- Suspected of malignancy: Cytological characteristics support the Diagnosis of malignancy but quantitatively or qualitatively is not enough to confirm it. VI.- Positive / malignant: Cytological changes are unequivocal of malignancy.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
Background: PubMed 25733127Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.
Background: PubMed 28898917Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.
Background: PubMed 27931638Lakhtakia S. Complications of diagnostic and therapeutic Endoscopic Ultrasound. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):807-823. doi: 10.1016/j.bpg.2016.10.008. Epub 2016 Oct 28.
Background: PubMed 7859968Wiersema MJ, Kochman ML, Cramer HM, Tao LC, Wiersema LM. Endosonography-guided real-time fine-needle aspiration biopsy. Gastrointest Endosc. 1994 Nov-Dec;40(6):700-7.
Background: PubMed 29301477Hedenstrom P, Demir A, Khodakaram K, Nilsson O, Sadik R. EUS-guided reverse bevel fine-needle biopsy sampling and open tip fine-needle aspiration in solid pancreatic lesions - a prospective, comparative study. Scand J Gastroenterol. 2018 Feb;53(2):231-237. doi: 10.1080/00365521.2017.1421704. Epub 2018 Jan 4.
Background: PubMed 29291601Ang TL, Kwek ABE, Wang LM. Diagnostic Endoscopic Ultrasound: Technique, Current Status and Future Directions. Gut Liver. 2018 Sep 15;12(5):483-496. doi: 10.5009/gnl17348.
Background: PubMed 25434654Wani S, Muthusamy VR, Komanduri S. EUS-guided tissue acquisition: an evidence-based approach (with videos). Gastrointest Endosc. 2014 Dec;80(6):939-59.e7. doi: 10.1016/j.gie.2014.07.066. No abstract available.
Background: PubMed 24033879Varadarajulu S, Hasan MK, Bang JY, Hebert-Magee S, Hawes RH. Endoscopic ultrasound-guided tissue acquisition. Dig Endosc. 2014 Jan;26 Suppl 1:62-9. doi: 10.1111/den.12146. Epub 2013 Aug 28.
Background: PubMed 27011940Jani BS, Rzouq F, Saligram S, Lim D, Rastogi A, Bonino J, Olyaee M. Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Lesions: A Systematic Review of Technical and Procedural Variables. N Am J Med Sci. 2016 Jan;8(1):1-11. doi: 10.4103/1947-2714.175185.
Background: PubMed 27071386Wang J, Wu X, Yin P, Guo Q, Hou W, Li Y, Wang Y, Cheng B. Comparing endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) versus fine needle biopsy (FNB) in the diagnosis of solid lesions: study protocol for a randomized controlled trial. Trials. 2016 Apr 12;17:198. doi: 10.1186/s13063-016-1316-2.
Background: PubMed 23433596Iwashita T, Nakai Y, Samarasena JB, Park DH, Zhang Z, Gu M, Lee JG, Chang KJ. High single-pass diagnostic yield of a new 25-gauge core biopsy needle for EUS-guided FNA biopsy in solid pancreatic lesions. Gastrointest Endosc. 2013 Jun;77(6):909-15. doi: 10.1016/j.gie.2013.01.001. Epub 2013 Feb 20.
Background: PubMed 25864902Bang JY, Hawes RH, Varadarajulu S. EUS-guided tissue acquisition: things are not always what they seem. Gastrointest Endosc. 2015 May;81(5):1300-1. doi: 10.1016/j.gie.2014.12.044. No abstract available.
Individual participant dataSharing planned: Undecided. This is a pilot study. It means a few patients will be included. We are not subjecting the participants to a higher risk than the endoscopic ultrasound itself and the procedures performed here are usual. The authors will only document the experience.

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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.

Dulce M. Rascon, M.D study director

Instituto Mexicano del Seguro Social

Alejandro Membrillo, Endoscopist principal investigator

Instituto Mexicano del Seguro Social

Luis F. Palacio, Endoscopist study chair

Instituto Mexicano del Seguro Social

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Digestive Cancer, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

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 2 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: finished, as of the sponsor's last update on 28 Feb 2019. 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 Mexico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The classification of Papanicolaou was used for the terminology in pancreatobiliary cytological evaluation of biopsy samples. (time frame: 4 months once the study has begun). 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 NCT03460197, which also lists 21 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 28 Feb 2019.