Pancreas NeoplasmNCT05095831
EUS Shear Wave for Solid Pancreatic Lesions.
An observational study of Pancreas Neoplasm and Pancreatitis, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial summary
The diagnosis of pancreas diseases is based on a combination of clinical signs, symptoms, and laboratory tests, but mainly on imaging techniques such as computed tomography (CT) and magnetic resonance (MR). However, CT/MR have variable sensitivity and specificity, with certain disadvantages. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pancreas Neoplasm, Pancreatitis, Pancreatitis, Acute
- What is being tested?
- Pancreas EUS shear wave and Pancreas EUS-elastography and EUS-guided biopsy
- How many people
- 25 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Oct 2021to 1 Apr 2022
- How long will I take part?
- 1 Year
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with solid pancreas lesions with an indication of EUS assessment.
Who may be able to join
- Neoplasia group: high suspicion of pancreas neoplasia based on computed tomography and/or nuclear magnetic resonance.
- Inflammatory group: high suspicion of acute or chronic pancreatitis based on computed tomography and/or nuclear magnetic resonance.
- Control group: patients without a history of any type of solid or hematologic malignancy, hepato-pancreato-biliary disease (including fatty liver and pancreas disease), tobacco/alcohol habits, or morbid obesity with bariatric surgery criteria; who require EUS evaluation (e.g., suspicious of a subepithelial lesion in the context of chronic dyspepsia).
Who cannot join
- Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with important impact on cardiac risk assessment (NHYA III/IV);
- Impossibility of EUS-guided biopsy (only for neoplasia or inflammatory group);
- Pregnancy or nursing;
- Refuse to participate in the study and/or to sign corresponding informed consent.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, 090505
About this study
Official title: Endoscopic Ultrasound Shear Wave for Neoplasia and Inflammation Assessment Among Solid Pancreas Lesions: a Case-control Observational Trial.
The diagnosis of pancreas diseases is based on a combination of clinical signs, symptoms, and laboratory tests, but mainly on imaging techniques such as computed tomography (CT) and magnetic resonance (MR). However, CT/MR have variable sensitivity and specificity, with certain disadvantages. Endoscopic ultrasound with elastography is an important resource with higher diagnostic accuracy in assessing solid pancreas lesions. Shear wave velocities of healthy parenchyma, acute, chronic and autoimmune pancreatitis, neoplastic lesions of the pancreas must be evaluated and compared.
Read the detailed description
The pancreas is a retroperitoneal organ that can cause inflammatory and neoplastic diseases, significantly impacting the quality of life to survival. Acute pancreatitis is one of the most frequent gastrointestinal causes for hospital admission in industrialized countries. Chronic pancreatitis, although lower in incidence, significantly reduces patients' quality of life. Pancreas cancer is one of the neoplastic diseases with high mortality worldwide. Those diseases have been associated with significant morbidity, mortality, and hospitalization costs
The diagnosis of pancreas diseases is based on a combination of clinical signs, symptoms, and laboratory tests, but mainly on imaging techniques such as computed tomography (CT) and magnetic resonance (MR). Imaging provides a significant contribution to the diagnosis of pancreatic diseases and severity estimation or staging for inflammatory and neoplastic lesions, respectively. However, CT/MR have variable sensitivity and specificity, with certain disadvantages.
Endoscopic ultrasound with elastography is an important resource with higher diagnostic accuracy in assessing solid pancreas lesions. Shear wave elastography is a novel technique that can measure tissue elasticity by generating shear waves inside the organ using the acoustic radiation force impulse.
EUS Shear wave velocities of healthy parenchyma and solid pancreas lesions as acute, chronic, autoimmune pancreatitis and neoplasia are under described and must be evaluated and contrasted. Therefore, the present study pursues to estimate the diagnostic accuracy of EUS Shear wave for neoplasia assessment among solid pancreas lesions.
- Conditions
- Pancreas Neoplasm, Pancreatitis, Pancreatitis, Acute, Pancreatitis, Chronic, Pancreatitis, Autoimmune
- Being tested
- Pancreas EUS shear wave, Pancreas EUS-elastography and EUS-guided biopsy
- Keywords
- Pancreatic Neoplasms, Carcinoma, Pancreatic Ductal, Pancreatic Intraductal Neoplasms, Pancreatitis, Pancreatitis, Chronic, Pancreatitis, Alcoholic, Pancreatitis, Acute Necrotizing, Pancreatitis, Acute Hemorrhagic, Autoimmune Pancreatitis
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Pancreatitis, Chronic, Autoimmune Pancreatitis, Carcinoma, Pancreatic Ductal, Pancreatic Intraductal Neoplasms, Pancreatitis, Alcoholic, Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreas EUS shear waveDiagnostic test
EUS Shear wave elastography (SWE) is a form of ultrasound elastography used in transabdominal ultrasonography. It measures tissue elasticity by generating shear waves inside the organ using the acoustic radiation force impulse (ARFI). The ultrasound machine monitors shear wave propagation and measures the velocity. The shear wave velocity, displayed in kilopascals [kPa] or meters per second. Also, the dispersion slope or ultrasound shear wave dispersion (SWD) will be recorded. It is the measure of viscosity [(m/sec)/kHz] using SWE.
A first endoscopist will perform EUS over pancreas tissue. Without any elastography assessment (strain ratio/histogram) , the endoscopist will take ten shear wave measurements of pancreas tissue elasticity by generating shear waves inside the pancreas using the ARFI.
Pancreas EUS-elastography and EUS-guided biopsyDiagnostic test
Pancreas EUS-elastography measures the pancreatic tissue stiffness through strain ratio (SR) and strain histogram (SH).
A second endoscopist blind to pancreas tissue shear wave findings will perform EUS-elastography with corresponding SR and SH measurements. The SR/SH will be measured and documented. Finally, a pancreas tissue biopsy will be performed. The impossibility of biopsy is an exclusion criterion (except in control patients). Due to ethical purposes, a biopsy will not be performed on patients from the control group.
| Study group | Role | What they receive |
|---|---|---|
| Suspicion of solid neoplastic lesion | Patients with high suspicion of solid pancreas neoplasia: carcinoma, intrapapillary mucinous neoplasia (IPMN), neuroendocrine tumor, lymphoma, or intrapancreatic metastasis; based on CT/MR. Receives: Diagnostic Test: Pancreas EUS shear wave; Diagnostic Test: Pancreas EUS-elastography and EUS-guided biopsy | |
| Suspicion of a solid inflammatory lesion | Patients with high suspicion of solid inflammatory lesions: acute, chronic, or autoimmune pancreatitis; based on CT/MR. Receives: Diagnostic Test: Pancreas EUS shear wave; Diagnostic Test: Pancreas EUS-elastography and EUS-guided biopsy | |
| Control group | Patients without a history of any type of solid or hematologic malignancy, hepato-pancreato-biliary disease (including fatty liver and pancreas disease), tobacco/alcohol habits, or morbid obesity with bariatric surgery criteria; who require EUS evaluation (e.g., suspicious of a subepithelial lesion in the context of chronic dyspepsia). Receives: Diagnostic Test: Pancreas EUS shear wave; Diagnostic Test: Pancreas EUS-elastography and EUS-guided biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SWE/SWD pancreas EUS shear wave
The median of ten SWE/SWD measures will be calculated to represent the final pancreas tissue shear wave measure per case. The higher the median, the more suspicious for neoplasia.
Measured: Two months
SR/SH pancreas EUS-elastography
The SR/SH measures will be recorded per case. A SR>15 kPa and a SH≤45 will be considered as highly suspicious for neoplasia.
Measured: Two months
EUS-biopsied histopathology findings
The pathologist will have access to all the clinical data of each patient, including EUS-elastography findings, except shear wave measurements, to determine if the assessed pancreas lesion was neoplasia or inflammatory. In addition, a preliminary diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of pancreas EUS shear wave measurements and pancreas EUS-elastography will be calculated using histopathology results as gold standard.
Measured: One month
Clinical condition at one-year follow-up
A gastroenterologist will follow patients for one year after the procedure. During this follow-up, there will record cases who undergo exploratory or onco-specific surgery (histopathology) and the number of patients who undergo onco-specific treatment (radiotherapy, radiosurgery, chemotherapy, and biological therapy) or clinical management/surveillance. Survival and cause of death will also be recorded when corresponding. This follow-up purposes of determining definitively if the assessed pancreas lesion was neoplasia or inflammatory. A definitive diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of pancreas EUS shear wave measurements and pancreas EUS-elastography will be calculated using a one-year follow-up as the gold standard.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Oct 2021
- Primary completion1 Jan 2022
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreas NeoplasmStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Robles-Medranda, MD FASGE, Principal investigator, Ecuadorian Institute of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095831
- Sponsor's protocol ID
- IECED-10152021
- Status last verified
- Jan 2022
- First submitted
- 15 Oct 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okasha H, Elkholy S, El-Sayed R, Wifi MN, El-Nady M, El-Nabawi W, El-Dayem WA, Radwan MI, Farag A, El-Sherif Y, Al-Gemeie E, Salman A, El-Sherbiny M, El-Mazny A, Mahdy RE. Real time endoscopic ultrasound elastography and strain ratio in the diagnosis of solid pancreatic lesions. World J Gastroenterol. 2017 Aug 28;23(32):5962-5968. doi: 10.3748/wjg.v23.i32.5962.
PubMed 28932088Bayramoglu Z, Akyol Sari ZN, Koker O, Adaletli I, Eker Omeroglu R. Shear wave elastography evaluation of liver, pancreas, spleen and kidneys in patients with familial mediterranean fever and amyloidosis. Br J Radiol. 2021 Dec;94(1128):20210237. doi: 10.1259/bjr.20210237. Epub 2021 Sep 14.
PubMed 34520686Platz Batista da Silva N, Engesser M, Hackl C, Brunner S, Hornung M, Schlitt HJ, Evert K, Stroszczynski C, Jung EM. Intraoperative Characterization of Pancreatic Tumors Using Contrast-Enhanced Ultrasound and Shear Wave Elastography for Optimization of Surgical Strategies. J Ultrasound Med. 2021 Aug;40(8):1613-1625. doi: 10.1002/jum.15545. Epub 2020 Oct 30.
PubMed 33124700Suzuki H, Ishikawa T, Ohno E, Iida T, Uetsuki K, Yashika J, Yamada K, Yoshikawa M, Furukawa K, Nakamura M, Honda T, Ishigami M, Kawashima H, Fujishiro M. An initial trial of quantitative evaluation of autoimmune pancreatitis using shear wave elastography and shear wave dispersion in transabdominal ultrasound. Pancreatology. 2021 Jun;21(4):682-687. doi: 10.1016/j.pan.2021.02.014. Epub 2021 Feb 20.
PubMed 33648879
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Shear Wave for Neoplasia and Inflammation Assessment Among Solid Pancreas Lesions: a Case-control Observational Trial.
- ClinicalTrials.gov ID
- NCT05095831
- Acronym / sponsor ID
- IECED-10152021
- Conditions
- Pancreas Neoplasm, Pancreatitis, Pancreatitis, Acute, Pancreatitis, Chronic, Pancreatitis, Autoimmune
- Keywords
- Pancreatic Neoplasms, Carcinoma, Pancreatic Ductal, Pancreatic Intraductal Neoplasms, Pancreatitis, Pancreatitis, Chronic, Pancreatitis, Alcoholic, Pancreatitis, Acute Necrotizing, Pancreatitis, Acute Hemorrhagic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 27 Oct 2021 (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.
The diagnosis of pancreas diseases is based on a combination of clinical signs, symptoms, and laboratory tests, but mainly on imaging techniques such as computed tomography (CT) and magnetic resonance (MR). However, CT/MR have variable sensitivity and specificity, with certain disadvantages. Endoscopic ultrasound with elastography is an important resource with higher diagnostic accuracy in assessing solid pancreas lesions. Shear wave velocities of healthy parenchyma, acute, chronic and autoimmune pancreatitis, neoplastic lesions of the pancreas must be evaluated and compared.
Detailed description
The pancreas is a retroperitoneal organ that can cause inflammatory and neoplastic diseases, significantly impacting the quality of life to survival. Acute pancreatitis is one of the most frequent gastrointestinal causes for hospital admission in industrialized countries. Chronic pancreatitis, although lower in incidence, significantly reduces patients' quality of life. Pancreas cancer is one of the neoplastic diseases with high mortality worldwide. Those diseases have been associated with significant morbidity, mortality, and hospitalization costs
The diagnosis of pancreas diseases is based on a combination of clinical signs, symptoms, and laboratory tests, but mainly on imaging techniques such as computed tomography (CT) and magnetic resonance (MR). Imaging provides a significant contribution to the diagnosis of pancreatic diseases and severity estimation or staging for inflammatory and neoplastic lesions, respectively. However, CT/MR have variable sensitivity and specificity, with certain disadvantages.
Endoscopic ultrasound with elastography is an important resource with higher diagnostic accuracy in assessing solid pancreas lesions. Shear wave elastography is a novel technique that can measure tissue elasticity by generating shear waves inside the organ using the acoustic radiation force impulse.
EUS Shear wave velocities of healthy parenchyma and solid pancreas lesions as acute, chronic, autoimmune pancreatitis and neoplasia are under described and must be evaluated and contrasted. Therefore, the present study pursues to estimate the diagnostic accuracy of EUS Shear wave for neoplasia assessment among solid pancreas lesions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspicion of solid neoplastic lesion | – | Diagnostic Test: Pancreas EUS shear wave, Diagnostic Test: Pancreas EUS-elastography and EUS-guided biopsyPatients with high suspicion of solid pancreas neoplasia: carcinoma, intrapapillary mucinous neoplasia (IPMN), neuroendocrine tumor, lymphoma, or intrapancreatic metastasis; based on CT/MR. |
| Suspicion of a solid inflammatory lesion | – | Diagnostic Test: Pancreas EUS shear wave, Diagnostic Test: Pancreas EUS-elastography and EUS-guided biopsyPatients with high suspicion of solid inflammatory lesions: acute, chronic, or autoimmune pancreatitis; based on CT/MR. |
| Control group | – | Diagnostic Test: Pancreas EUS shear wave, Diagnostic Test: Pancreas EUS-elastography and EUS-guided biopsyPatients without a history of any type of solid or hematologic malignancy, hepato-pancreato-biliary disease (including fatty liver and pancreas disease), tobacco/alcohol habits, or morbid obesity with bariatric surgery criteria; who require EUS evaluation (e.g., suspicious of a subepithelial lesion in the context of chronic dyspepsia). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with solid pancreas lesions with an indication of EUS assessment.
Key inclusion criteria (3 listed)
- Neoplasia group: high suspicion of pancreas neoplasia based on computed tomography and/or nuclear magnetic resonance.
- Inflammatory group: high suspicion of acute or chronic pancreatitis based on computed tomography and/or nuclear magnetic resonance.
- Control group: patients without a history of any type of solid or hematologic malignancy, hepato-pancreato-biliary disease (including fatty liver and pancreas disease), tobacco/alcohol habits, or morbid obesity with bariatric surgery criteria; who require EUS evaluation (e.g., suspicious of a subepithelial lesion in the context of chronic dyspepsia).
Key exclusion criteria (4 listed)
- Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with important impact on cardiac risk assessment (NHYA III/IV);
- Impossibility of EUS-guided biopsy (only for neoplasia or inflammatory group);
- Pregnancy or nursing;
- Refuse to participate in the study and/or to sign corresponding 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 |
|---|---|---|
| Pancreas EUS shear waveEUS Shear wave elastography (SWE) is a form of ultrasound elastography used in transabdominal ultrasonography. It measures tissue elasticity by generating shear waves inside the organ using the acoustic radiation force impulse (ARFI). The ultrasound machine monitors shear wave propagation and measures the velocity. The shear wave velocity, displayed in kilopascals [kPa] or meters per second. Also, the dispersion slope or ultrasound shear wave dispersion (SWD) will be recorded. It is the measure of viscosity [(m/sec)/kHz] using SWE. A first endoscopist will perform EUS over pancreas tissue. Without any elastography assessment (strain ratio/histogram) , the endoscopist will take ten shear wave measurements of pancreas tissue elasticity by generating shear waves inside the pancreas using the ARFI. | Diagnostic test | Control group, Suspicion of a solid inflammatory lesion, Suspicion of solid neoplastic lesion |
| Pancreas EUS-elastography and EUS-guided biopsyPancreas EUS-elastography measures the pancreatic tissue stiffness through strain ratio (SR) and strain histogram (SH). A second endoscopist blind to pancreas tissue shear wave findings will perform EUS-elastography with corresponding SR and SH measurements. The SR/SH will be measured and documented. Finally, a pancreas tissue biopsy will be performed. The impossibility of biopsy is an exclusion criterion (except in control patients). Due to ethical purposes, a biopsy will not be performed on patients from the control group. | Diagnostic test | Control group, Suspicion of a solid inflammatory lesion, Suspicion of solid neoplastic lesion |
Primary outcome
SWE/SWD pancreas EUS shear wave
Time frame: Two months
The median of ten SWE/SWD measures will be calculated to represent the final pancreas tissue shear wave measure per case. The higher the median, the more suspicious for neoplasia.
SR/SH pancreas EUS-elastography
Time frame: Two months
The SR/SH measures will be recorded per case. A SR>15 kPa and a SH≤45 will be considered as highly suspicious for neoplasia.
EUS-biopsied histopathology findings
Time frame: One month
The pathologist will have access to all the clinical data of each patient, including EUS-elastography findings, except shear wave measurements, to determine if the assessed pancreas lesion was neoplasia or inflammatory. In addition, a preliminary diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of pancreas EUS shear wave measurements and pancreas EUS-elastography will be calculated using histopathology results as gold standard.
Clinical condition at one-year follow-up
Time frame: One year
A gastroenterologist will follow patients for one year after the procedure. During this follow-up, there will record cases who undergo exploratory or onco-specific surgery (histopathology) and the number of patients who undergo onco-specific treatment (radiotherapy, radiosurgery, chemotherapy, and biological therapy) or clinical management/surveillance. Survival and cause of death will also be recorded when corresponding. This follow-up purposes of determining definitively if the assessed pancreas lesion was neoplasia or inflammatory. A definitive diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of pancreas EUS shear wave measurements and pancreas EUS-elastography will be calculated using a one-year follow-up as the gold standard.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Results publication: PubMed 28932088Okasha H, Elkholy S, El-Sayed R, Wifi MN, El-Nady M, El-Nabawi W, El-Dayem WA, Radwan MI, Farag A, El-Sherif Y, Al-Gemeie E, Salman A, El-Sherbiny M, El-Mazny A, Mahdy RE. Real time endoscopic ultrasound elastography and strain ratio in the diagnosis of solid pancreatic lesions. World J Gastroenterol. 2017 Aug 28;23(32):5962-5968. doi: 10.3748/wjg.v23.i32.5962.
- Results publication: PubMed 34520686Bayramoglu Z, Akyol Sari ZN, Koker O, Adaletli I, Eker Omeroglu R. Shear wave elastography evaluation of liver, pancreas, spleen and kidneys in patients with familial mediterranean fever and amyloidosis. Br J Radiol. 2021 Dec;94(1128):20210237. doi: 10.1259/bjr.20210237. Epub 2021 Sep 14.
- Results publication: PubMed 33124700Platz Batista da Silva N, Engesser M, Hackl C, Brunner S, Hornung M, Schlitt HJ, Evert K, Stroszczynski C, Jung EM. Intraoperative Characterization of Pancreatic Tumors Using Contrast-Enhanced Ultrasound and Shear Wave Elastography for Optimization of Surgical Strategies. J Ultrasound Med. 2021 Aug;40(8):1613-1625. doi: 10.1002/jum.15545. Epub 2020 Oct 30.
- Results publication: PubMed 33648879Suzuki H, Ishikawa T, Ohno E, Iida T, Uetsuki K, Yashika J, Yamada K, Yoshikawa M, Furukawa K, Nakamura M, Honda T, Ishigami M, Kawashima H, Fujishiro M. An initial trial of quantitative evaluation of autoimmune pancreatitis using shear wave elastography and shear wave dispersion in transabdominal ultrasound. Pancreatology. 2021 Jun;21(4):682-687. doi: 10.1016/j.pan.2021.02.014. Epub 2021 Feb 20.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Robles-Medranda, MD FASGE principal investigator
Ecuadorian Institute of Digestive Diseases
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 Pancreas Neoplasm and Pancreatitis, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. 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 Ecuador. 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?
Results are not available in the source record.
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?
SWE/SWD pancreas EUS shear wave (time frame: Two months). The study lists 4 primary outcomes in all. 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 NCT05095831, which also lists 4 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 4 Jan 2022.