Pancreatic Cystic LesionPrePaCystNCT06535490
Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions
An observational study of Pancreatic Cystic Lesion, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial summary
Large prospective comparative observational study in numerous reference centers in France, comparing infectious complications in patients admitted for pancreatic cystic lesions (PCL) aspiration performed with or without antibiotic prophylaxis (ATBp) according to the usual practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cystic Lesion
- What is being tested?
- EUS-FNA and ATBp
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,702 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2024to 15 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic cystic lesions for whom an EUS-FNA is indicated
Who may be able to join
- Patient referred for diagnostic aspiration of a pancreatic cystic lesion
- Patient aged 18 years or older
- Patient with ASA 1, ASA 2, ASA 3 status
- No participation in another concurrent clinical study
Who cannot join
- Patient under 18 years old
- Patient with ASA 4 or ASA 5 status
- Pregnant woman
- Patient with coagulation disorders preventing the performance of an EUS-FNA: PT < 50%, platelets < 50,000/mm³, current effective anticoagulation, ongoing clopidogrel, prasugrel, or ticagrelor treatment
- Patient unable to personally express non-opposition or legally protected adult
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Clinique Paris-Bercy
Charenton-le-Pont, 94220
David KARSENTI, MD, +33143967850, karsenti.paris@gmail.com
About this study
Official title: Prevention of Infection After EUS-FNA of Pancreatic Cystic Lesions: A French Multicenter Prospective Comparative Observational Study
Large prospective comparative observational study in numerous reference centers in France, comparing infectious complications in patients admitted for pancreatic cystic lesions (PCL) aspiration performed with or without antibiotic prophylaxis (ATBp) according to the usual practices.
This is a prospective, comparative, observational, multicenter study, with the primary objective of comparing the infection rates in pancreatic cystic lesions (PCL) aspirated under EUS, with and without the administration of ATBp.
A sample size of 1702 patients will be needed over a 3-year study period.
Read the detailed description
The complication rate after EUS fine needle aspiration (EUS-FNA) for pancreatic cystic lesions (PCL) is low, around 1-3% according to various series. However, it has long been recommended to perform this procedure under antibiotic prophylaxis (ATBp). Due to the risk of developing resistance to certain classes of antibiotics and the risk of complications, particularly allergic reactions, the role of ATBp in this indication needs to be reconsidered. The latest recommendations from European and French societies do not support the systematic formal indication of ATBp for aspiration under EUS. Because the literature on the subject is sparse and equivocal, practices remain varied (some performing PCL aspirations with and others without ATBp), and scientific societies do not provide a formal stance on the benefit of such ATBp. Therefore, we decided to conduct a very large prospective comparative observational study in numerous reference centers in France (centers of the Research and Action Group in Endoscopy - GRAPHE), comparing infectious complications in patients admitted for EUS-FNA for PCL performed with or without ATBp according to the usual practices .
This is a prospective, comparative, observational, multicenter study.
Primary objective:
Comparison of infection rates after EUS-FNA for pancreatic cystic lesions (PCL) , with and without the administration of ATBp.
Secondary objectives:
Rates of other infectious complications (pulmonary, urinary, etc.) Rates of post-ATBp complications, particularly allergic reactions Prolongation of scheduled hospitalization Evaluation of factors associated with post-EUS aspiration infection of PCL
After the endoscopic exploration, the patient will be monitored for the potential occurrence of complications related to EUS (perforation, hemorrhage, infection, allergy, etc.). Any adverse events will be recorded at 30 days post-procedure.
A sample size of 1702 patients will be needed over a 3-year study period.
- Conditions
- Pancreatic Cystic Lesion
- Being tested
- EUS-FNA, ATBp
- Keywords
- EUS-FNA, Pancreatic cystic lesion, Antibiotic prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNAProcedure or surgery
Also called EUS fine needle aspiration
Puncture of pancreatic cystic lesion with a fine needle under EUS guidance
ATBpDrug
Also called Antibiotic prophylaxis
Antibiotic prophylaxis consists of a single intravenous administration before or at the beginning of the procedure according to the common practices of each practitioner or unit
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNA for PCL with ATBp | Patients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp Receives: Procedure: EUS-FNA; Drug: ATBp | |
| EUS-FNA for PCL without ATBp | Patients undergoing EUS-FNA for pancreatic cystic lesions without ATBp Receives: Procedure: EUS-FNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post EUS-FNA PCL infection rate
Post-EUS-FNA infection rate of PCL (patients exhibiting clinical and biological signs - fever >38.5°C, neutrophilic leukocytosis, elevated CRP, pathogen identification in blood cultures - indicative of sepsis requiring prolonged antibiotic therapy). The occurrence of the aforementioned clinical and biological signs, along with imaging evidence (such as cyst wall thickening or presence of intracystic air images) and the absence of another infection source (urinary, pulmonary, venous, etc.) will lead to the diagnosis of post-FNA infection. Centralized validation of infection cases will be conducted by an expert panel based on clinical, biological, and imaging findings.
Measured: 30 days
Secondary outcomes (15)
Rate of urinary infectious complications
Number of patients with at least one urinary infection within 21-30 days after EUS-FNA
Measured: 30 days
Rate of post-ATBp allergic reactions
Number of patients with at least one allergic reaction within 21-30 days after EUS-FNA
Measured: 30 days
Duration and extension of hospitalization
Number of hospitalization days per stay within 30 days following EUS-FNA
Measured: 30 days
Diameter of the needle used for EUS-FNA
25G, 22G, 20G, or 19G
Measured: 1 days
Associated procedures (confocal endomicroscopy or intracystic biopsy)
Yes or No
Measured: 1 days
Appearance of the fluid
Thin, thick, hemorrhagic
Measured: 1 day
Complete aspiration of the cyst fluid
Yes or No
Measured: 1 day
Nature of the PCL
mucinous vs. non-mucinous
Measured: 30 days
Age
Years
Measured: 1 day
Gender
Male or female
Measured: 1 day
Diabetes
Yes or No
Measured: 1 day
Immunosuppression
Yes or No
Measured: 1 day
BMI
Weight/(size)2 expressed in in kg/m^2
Measured: 1 day
history of aspiration of the same lesion
Yes or No
Measured: 1 day
Rate of pulmonary infectious complications
Number of patients with at least one pulmonary infection within 21-30 days after EUS-FNA
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cystic LesionStudies 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
- 1,702 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David KARSENTI, Société Française d'Endoscopie Digestive
- Investigators
- David KARSENTI, Study chair, Societe Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535490
- Sponsor's protocol ID
- SFED-165
- Acronym
- PrePaCyst
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 28898917Facciorusso A, Mohan BP, Tacelli M, Crino SF, Antonini F, Fantin A, Barresi L. Use of antibiotic prophylaxis is not needed for endoscopic ultrasound-guided fine-needle aspiration of pancreatic cysts: a meta-analysis. Expert Rev Gastroenterol Hepatol. 2020 Oct;14(10):999-1005. doi: 10.1080/17474124.2020.1797486. Epub 2020 Jul 25.
PubMed 32674699Facciorusso A, Arevalo-Mora M, Conti Bellocchi MC, Bernardoni L, Ramai D, Gkolfakis P, Loizzi D, Muscatiello N, Ambrosi A, Tartaglia N, Robles-Medranda C, Stasi E, Ofosu A, Crino SF. Impact of Antibiotic Prophylaxis on Infection Rate after Endoscopic Ultrasound Through-the-Needle Biopsy of Pancreatic Cysts: A Propensity Score-Matched Study. Diagnostics (Basel). 2022 Jan 16;12(1):211. doi: 10.3390/diagnostics12010211.
PubMed 35054378Facciorusso A, Buccino VR, Turco A, Antonino M, Muscatiello N. Antibiotics Do Not Decrease the Rate of Infection After Endoscopic Ultrasound Fine-Needle Aspiration of Pancreatic Cysts. Dig Dis Sci. 2019 Aug;64(8):2308-2315. doi: 10.1007/s10620-019-05655-x. Epub 2019 May 7.
PubMed 31065897Klein A, Qi R, Nagubandi S, Lee E, Kwan V. Single-dose intra-procedural ceftriaxone during endoscopic ultrasound fine-needle aspiration of pancreatic cysts is safe and effective: results from a single tertiary center. Ann Gastroenterol. 2017;30(2):237-241. doi: 10.20524/aog.2016.0118. Epub 2016 Dec 22.
PubMed 28243046Guarner-Argente C, Shah P, Buchner A, Ahmad NA, Kochman ML, Ginsberg GG. Use of antimicrobials for EUS-guided FNA of pancreatic cysts: a retrospective, comparative analysis. Gastrointest Endosc. 2011 Jul;74(1):81-6. doi: 10.1016/j.gie.2011.03.1244.
PubMed 21704808Lee LS, Saltzman JR, Bounds BC, Poneros JM, Brugge WR, Thompson CC. EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. Clin Gastroenterol Hepatol. 2005 Mar;3(3):231-6. doi: 10.1016/s1542-3565(04)00618-4.
PubMed 15765442Colan-Hernandez J, Sendino O, Loras C, Pardo A, Gornals JB, Concepcion M, Sanchez-Montes C, Murzi M, Andujar X, Velasquez-Rodriguez J, Rodriguez de Miguel C, Fernandez-Esparrach G, Gines A, Guarner-Argente C. Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial. Gastroenterology. 2020 May;158(6):1642-1649.e1. doi: 10.1053/j.gastro.2020.01.025. Epub 2020 Jan 20.
PubMed 31972236
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Infection After EUS-FNA of Pancreatic Cystic Lesions: A French Multicenter Prospective Comparative Observational Study
- ClinicalTrials.gov ID
- NCT06535490
- Acronym / sponsor ID
- PrePaCyst / SFED-165
- Conditions
- Pancreatic Cystic Lesion
- Keywords
- EUS-FNA, Pancreatic cystic lesion, Antibiotic prophylaxis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,702 participants (estimated)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 2 Aug 2024 (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.
Large prospective comparative observational study in numerous reference centers in France, comparing infectious complications in patients admitted for pancreatic cystic lesions (PCL) aspiration performed with or without antibiotic prophylaxis (ATBp) according to the usual practices.
This is a prospective, comparative, observational, multicenter study, with the primary objective of comparing the infection rates in pancreatic cystic lesions (PCL) aspirated under EUS, with and without the administration of ATBp.
A sample size of 1702 patients will be needed over a 3-year study period.
Detailed description
The complication rate after EUS fine needle aspiration (EUS-FNA) for pancreatic cystic lesions (PCL) is low, around 1-3% according to various series. However, it has long been recommended to perform this procedure under antibiotic prophylaxis (ATBp). Due to the risk of developing resistance to certain classes of antibiotics and the risk of complications, particularly allergic reactions, the role of ATBp in this indication needs to be reconsidered. The latest recommendations from European and French societies do not support the systematic formal indication of ATBp for aspiration under EUS. Because the literature on the subject is sparse and equivocal, practices remain varied (some performing PCL aspirations with and others without ATBp), and scientific societies do not provide a formal stance on the benefit of such ATBp. Therefore, we decided to conduct a very large prospective comparative observational study in numerous reference centers in France (centers of the Research and Action Group in Endoscopy - GRAPHE), comparing infectious complications in patients admitted for EUS-FNA for PCL performed with or without ATBp according to the usual practices .
This is a prospective, comparative, observational, multicenter study.
Primary objective:
Comparison of infection rates after EUS-FNA for pancreatic cystic lesions (PCL) , with and without the administration of ATBp.
Secondary objectives:
Rates of other infectious complications (pulmonary, urinary, etc.) Rates of post-ATBp complications, particularly allergic reactions Prolongation of scheduled hospitalization Evaluation of factors associated with post-EUS aspiration infection of PCL
After the endoscopic exploration, the patient will be monitored for the potential occurrence of complications related to EUS (perforation, hemorrhage, infection, allergy, etc.). Any adverse events will be recorded at 30 days post-procedure.
A sample size of 1702 patients will be needed over a 3-year study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA for PCL with ATBp | – | Procedure: EUS-FNA, Drug: ATBpPatients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp |
| EUS-FNA for PCL without ATBp | – | Procedure: EUS-FNAPatients undergoing EUS-FNA for pancreatic cystic lesions without ATBp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic cystic lesions for whom an EUS-FNA is indicated
Key inclusion criteria (4 listed)
- Patient referred for diagnostic aspiration of a pancreatic cystic lesion
- Patient aged 18 years or older
- Patient with ASA 1, ASA 2, ASA 3 status
- No participation in another concurrent clinical study
Key exclusion criteria (5 listed)
- Patient under 18 years old
- Patient with ASA 4 or ASA 5 status
- Pregnant woman
- Patient with coagulation disorders preventing the performance of an EUS-FNA: PT < 50%, platelets < 50,000/mm³, current effective anticoagulation, ongoing clopidogrel, prasugrel, or ticagrelor treatment
- Patient unable to personally express non-opposition or legally protected adult
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 |
|---|---|---|
| EUS-FNAAlso: EUS fine needle aspirationPuncture of pancreatic cystic lesion with a fine needle under EUS guidance | Procedure or surgery | EUS-FNA for PCL with ATBp, EUS-FNA for PCL without ATBp |
| ATBpAlso: Antibiotic prophylaxisAntibiotic prophylaxis consists of a single intravenous administration before or at the beginning of the procedure according to the common practices of each practitioner or unit | Drug | EUS-FNA for PCL with ATBp |
Primary outcome
Post EUS-FNA PCL infection rate
Time frame: 30 days
Post-EUS-FNA infection rate of PCL (patients exhibiting clinical and biological signs - fever >38.5°C, neutrophilic leukocytosis, elevated CRP, pathogen identification in blood cultures - indicative of sepsis requiring prolonged antibiotic therapy). The occurrence of the aforementioned clinical and biological signs, along with imaging evidence (such as cyst wall thickening or presence of intracystic air images) and the absence of another infection source (urinary, pulmonary, venous, etc.) will lead to the diagnosis of post-FNA infection. Centralized validation of infection cases will be conducted by an expert panel based on clinical, biological, and imaging findings.
15 secondary outcomes
Rate of urinary infectious complications
Time frame: 30 days
Rate of post-ATBp allergic reactions
Time frame: 30 days
Duration and extension of hospitalization
Time frame: 30 days
Diameter of the needle used for EUS-FNA
Time frame: 1 days
Associated procedures (confocal endomicroscopy or intracystic biopsy)
Time frame: 1 days
Appearance of the fluid
Time frame: 1 day
Complete aspiration of the cyst fluid
Time frame: 1 day
Nature of the PCL
Time frame: 30 days
Age
Time frame: 1 day
Gender
Time frame: 1 day
Diabetes
Time frame: 1 day
Immunosuppression
Time frame: 1 day
BMI
Time frame: 1 day
history of aspiration of the same lesion
Time frame: 1 day
Rate of pulmonary infectious complications
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Results publication: 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.
- Results publication: PubMed 32674699Facciorusso A, Mohan BP, Tacelli M, Crino SF, Antonini F, Fantin A, Barresi L. Use of antibiotic prophylaxis is not needed for endoscopic ultrasound-guided fine-needle aspiration of pancreatic cysts: a meta-analysis. Expert Rev Gastroenterol Hepatol. 2020 Oct;14(10):999-1005. doi: 10.1080/17474124.2020.1797486. Epub 2020 Jul 25.
- Results publication: PubMed 35054378Facciorusso A, Arevalo-Mora M, Conti Bellocchi MC, Bernardoni L, Ramai D, Gkolfakis P, Loizzi D, Muscatiello N, Ambrosi A, Tartaglia N, Robles-Medranda C, Stasi E, Ofosu A, Crino SF. Impact of Antibiotic Prophylaxis on Infection Rate after Endoscopic Ultrasound Through-the-Needle Biopsy of Pancreatic Cysts: A Propensity Score-Matched Study. Diagnostics (Basel). 2022 Jan 16;12(1):211. doi: 10.3390/diagnostics12010211.
- Results publication: PubMed 31065897Facciorusso A, Buccino VR, Turco A, Antonino M, Muscatiello N. Antibiotics Do Not Decrease the Rate of Infection After Endoscopic Ultrasound Fine-Needle Aspiration of Pancreatic Cysts. Dig Dis Sci. 2019 Aug;64(8):2308-2315. doi: 10.1007/s10620-019-05655-x. Epub 2019 May 7.
- Results publication: PubMed 28243046Klein A, Qi R, Nagubandi S, Lee E, Kwan V. Single-dose intra-procedural ceftriaxone during endoscopic ultrasound fine-needle aspiration of pancreatic cysts is safe and effective: results from a single tertiary center. Ann Gastroenterol. 2017;30(2):237-241. doi: 10.20524/aog.2016.0118. Epub 2016 Dec 22.
- Results publication: PubMed 21704808Guarner-Argente C, Shah P, Buchner A, Ahmad NA, Kochman ML, Ginsberg GG. Use of antimicrobials for EUS-guided FNA of pancreatic cysts: a retrospective, comparative analysis. Gastrointest Endosc. 2011 Jul;74(1):81-6. doi: 10.1016/j.gie.2011.03.1244.
- Results publication: PubMed 15765442Lee LS, Saltzman JR, Bounds BC, Poneros JM, Brugge WR, Thompson CC. EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. Clin Gastroenterol Hepatol. 2005 Mar;3(3):231-6. doi: 10.1016/s1542-3565(04)00618-4.
- Results publication: PubMed 31972236Colan-Hernandez J, Sendino O, Loras C, Pardo A, Gornals JB, Concepcion M, Sanchez-Montes C, Murzi M, Andujar X, Velasquez-Rodriguez J, Rodriguez de Miguel C, Fernandez-Esparrach G, Gines A, Guarner-Argente C. Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial. Gastroenterology. 2020 May;158(6):1642-1649.e1. doi: 10.1053/j.gastro.2020.01.025. Epub 2020 Jan 20.
- 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.
David KARSENTI study chair
Societe Française d'Endoscopie Digestive
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 Pancreatic Cystic Lesion, run by Société Française d'Endoscopie Digestive at 1 site in France.
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: opening soon, as of the sponsor's last update on 2 Aug 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David KARSENTI, MD (+33 1 43 96 78 50, karsenti.paris@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post EUS-FNA PCL infection rate (time frame: 30 days). 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 NCT06535490, which also lists 8 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 2 Aug 2024.