Pancreatic NeoplasmNCT04623749
Percutaneous Versus EUS FNAC in Pancreatic Masses
A study testing US and EUS in people with Pancreatic Neoplasm and Pancreatic Cyst, run by Ola Kamal Mohammed Galal.
Trial summary
We aim to evaluate the role of Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) in diagnosis of pancreatic masses compared to endoscopic ultrasound (EUS) guided fine needle aspiration cytology (FNAC). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Neoplasm, Pancreatic Cyst, Pancreatic Abscess
- What is being tested?
- US and EUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Mar 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 50 Patients in different sex \& age groups with pancreatic masses
Who cannot join
- Any general contraindications for FNAC or EUS in some cases as Coagulopathy with INR >1.5 or platelet count <50,000/mmc, Antithrombotic therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Percutaneous Versus Endoscopic Guided Fine Needle Aspiration Cytology in Diagnosis of Pancreatic Masses
We aim to evaluate the role of Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) in diagnosis of pancreatic masses compared to endoscopic ultrasound (EUS) guided fine needle aspiration cytology (FNAC).
Read the detailed description
Pancreatic cancer is the fourth leading cause of cancer-related mortality in the United States. Over 45,000 patients are diagnosed each year in the United States, and the majority of these patients succumb to their disease. Eighty percentages of patients are diagnosed with advanced, unrespectable disease. According to the latest statistics, only 7 % of patients survive 5 years after diagnosis. While the 5-year survival rate improves to 25 % in patients presenting with stage 1or localized disease, only 9 % of patients are identified at this early stage. The majority of patients (53%) presents with distant metastatic disease, and have a 5-year survival of 2%.
Improving the prognosis of patients with pancreatic cancer is a challenge. Overall, pancreatic cancer has one of the worst prognoses among all cancers; however, the prognosis is better if cancer is detected at an early stage. For example, patients with pancreatic cancers ≤1 cm in size at the time of diagnosis have a 5-year survival rate of 80.4% . Because such small cancers now account for 0.8% of all pancreatic cancer, detection of more small cancers would contribute to improving mortality rates.
The diagnostic approach to a possible pancreatic mass lesion relies first upon various non-invasive imaging modalities, including computed tomography, ultrasound, and magnetic resonance imaging techniques. Once a suspect lesion has been identified, tissue acquisition for characterization of the lesion is often paramount in developing an individualized therapeutic approach. Tools , in addition to radiologic imaging , currently employed in the initial evaluation of a patient with a pancreatic mass lesion include serum tumor markers , endoscopic retrograde cholangiopancreatography, Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) .
Advancements in radiologic and endoscopic ultrasound (EUS) imaging have improved our ability to detect and stage pancreatic masses allowing for more selective surgical intervention for patients with resectable disease. Owing to the low sensitivity of cross-sectional imaging to detect small tumors in the pancreas.
Endoscopic ultrasound (EUS), in which the tip of the endoscope contains a high-frequency transducer , provides high resolution images of the pancreas. Indeed , its high resolution in experienced hands enables detection of focal lesions as small as 2-5 mm .
Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) has emerged as a primary diagnostic modality in investigation in patients with pancreatic lesions. This technique was introduced into clinical practice nearly 3 decades ago and has proved to be a simple, cost-effective and minimally invasive technique that can yield material for tissue diagnosis .
- Conditions
- Pancreatic Neoplasm, Pancreatic Cyst, Pancreatic Abscess
- Being tested
- US, EUS
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USProcedure or surgery
Percutaneous Ultrasound guided FNAC
EUSProcedure or surgery
Endoscopic Ultrasound guided FNAC
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous US guided FNAC in pancreatic masses | Active comparator | Not described Receives: Procedure: US |
| EUS guided FNAC in pancreatic masses | Active comparator | Not described Receives: Procedure: EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by Trans abdominal US-FNAC. diagnostic accuracy
Percutaneous US guided FNAC technique
Measured: intraopeatve
Secondary outcomes (1)
Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNAC. diagnostic accuracy
EUS guided FNAC technique
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ola Kamal Mohammed Galal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ola Kamal Mohammed Galal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623749
- Sponsor's protocol ID
- FNAC in pancreatic masses
- Status last verified
- Jun 2021
- First submitted
- 4 Nov 2020
- Last updated
- 14 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.
PubMed 25559415Egawa S, Toma H, Ohigashi H, Okusaka T, Nakao A, Hatori T, Maguchi H, Yanagisawa A, Tanaka M. Japan Pancreatic Cancer Registry; 30th year anniversary: Japan Pancreas Society. Pancreas. 2012 Oct;41(7):985-92. doi: 10.1097/MPA.0b013e318258055c.
PubMed 22750974
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Versus Endoscopic Guided Fine Needle Aspiration Cytology in Diagnosis of Pancreatic Masses
- ClinicalTrials.gov ID
- NCT04623749
- Acronym / sponsor ID
- FNAC in pancreatic masses
- Conditions
- Pancreatic Neoplasm, Pancreatic Cyst, Pancreatic Abscess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ola Kamal Mohammed GalalUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 10 Nov 2020 (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.
We aim to evaluate the role of Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) in diagnosis of pancreatic masses compared to endoscopic ultrasound (EUS) guided fine needle aspiration cytology (FNAC).
Detailed description
Pancreatic cancer is the fourth leading cause of cancer-related mortality in the United States. Over 45,000 patients are diagnosed each year in the United States, and the majority of these patients succumb to their disease. Eighty percentages of patients are diagnosed with advanced, unrespectable disease. According to the latest statistics, only 7 % of patients survive 5 years after diagnosis. While the 5-year survival rate improves to 25 % in patients presenting with stage 1or localized disease, only 9 % of patients are identified at this early stage. The majority of patients (53%) presents with distant metastatic disease, and have a 5-year survival of 2%.
Improving the prognosis of patients with pancreatic cancer is a challenge. Overall, pancreatic cancer has one of the worst prognoses among all cancers; however, the prognosis is better if cancer is detected at an early stage. For example, patients with pancreatic cancers ≤1 cm in size at the time of diagnosis have a 5-year survival rate of 80.4% . Because such small cancers now account for 0.8% of all pancreatic cancer, detection of more small cancers would contribute to improving mortality rates.
The diagnostic approach to a possible pancreatic mass lesion relies first upon various non-invasive imaging modalities, including computed tomography, ultrasound, and magnetic resonance imaging techniques. Once a suspect lesion has been identified, tissue acquisition for characterization of the lesion is often paramount in developing an individualized therapeutic approach. Tools , in addition to radiologic imaging , currently employed in the initial evaluation of a patient with a pancreatic mass lesion include serum tumor markers , endoscopic retrograde cholangiopancreatography, Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) .
Advancements in radiologic and endoscopic ultrasound (EUS) imaging have improved our ability to detect and stage pancreatic masses allowing for more selective surgical intervention for patients with resectable disease. Owing to the low sensitivity of cross-sectional imaging to detect small tumors in the pancreas.
Endoscopic ultrasound (EUS), in which the tip of the endoscope contains a high-frequency transducer , provides high resolution images of the pancreas. Indeed , its high resolution in experienced hands enables detection of focal lesions as small as 2-5 mm .
Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) has emerged as a primary diagnostic modality in investigation in patients with pancreatic lesions. This technique was introduced into clinical practice nearly 3 decades ago and has proved to be a simple, cost-effective and minimally invasive technique that can yield material for tissue diagnosis .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous US guided FNAC in pancreatic masses | Active comparator | Procedure: US |
| EUS guided FNAC in pancreatic masses | Active comparator | Procedure: EUS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 50 Patients in different sex \& age groups with pancreatic masses
Key exclusion criteria (1 listed)
- Any general contraindications for FNAC or EUS in some cases as Coagulopathy with INR >1.5 or platelet count <50,000/mmc, Antithrombotic therapy.
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 |
|---|---|---|
| USPercutaneous Ultrasound guided FNAC | Procedure or surgery | Percutaneous US guided FNAC in pancreatic masses |
| EUSEndoscopic Ultrasound guided FNAC | Procedure or surgery | EUS guided FNAC in pancreatic masses |
Primary outcome
Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by Trans abdominal US-FNAC. diagnostic accuracy
Time frame: intraopeatve
Percutaneous US guided FNAC technique
1 secondary outcome
Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNAC. diagnostic accuracy
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Background: PubMed 25559415Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.
- Background: PubMed 22750974Egawa S, Toma H, Ohigashi H, Okusaka T, Nakao A, Hatori T, Maguchi H, Yanagisawa A, Tanaka M. Japan Pancreatic Cancer Registry; 30th year anniversary: Japan Pancreas Society. Pancreas. 2012 Oct;41(7):985-92. doi: 10.1097/MPA.0b013e318258055c.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing US and EUS in people with Pancreatic Neoplasm and Pancreatic Cyst, run by Ola Kamal Mohammed Galal.
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 1 inclusion and 1 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ola KM Galal, master (01092502106, olakmgalal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by Trans abdominal US-FNAC. diagnostic accuracy (time frame: intraopeatve). 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 NCT04623749, which also lists 2 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 14 Jun 2021.