Pancreatic CystNCT03884179
Diagnosis of PCL With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy
An observational study of Pancreatic Cyst and Pancreatic Neuroendocrine Carcinoma, run by Sahlgrenska University Hospital.
Trial summary
Pancreatic cystic lesions (PCLs) comprise of a heterogeneous group of entities that are benign, premalignant or malignant. With increased use of modern imaging techniques in recent years, incidentally discovered PCL have become much more common. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cyst, Pancreatic Neuroendocrine Carcinoma, Pancreatic Pseudocyst
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2007to 1 Mar 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017. The catchemnt area of this cente has a population of about two million.
Who may be able to join
- Patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017, who underwent pancreas resection
- Oral and written consent of patients examined
Who cannot join
- None
About this study
Official title: Diagnosis of Pancreatic Cystic Lesions With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy
Pancreatic cystic lesions (PCLs) comprise of a heterogeneous group of entities that are benign, premalignant or malignant. With increased use of modern imaging techniques in recent years, incidentally discovered PCL have become much more common. However, imaging modalities for characterising PCL is a known clinical uncertainty since imaging is capable of detecting these lesions but may often not be able to distinguish malignant from benign lesions. Incorrect assessment of PCL can lead to fatal consequences because a malignant lesion may not be treated and a benign may be unnecessarily resected. The aim of this study was to assess the performance of endoscopic ultrasound with fine-needle aspiration (EUS-FNA) in the diagnosis of pancreatic cystic lesions compared to cross-sectional imaging modalities (CT/MRI). Our hypothesis is that EUS-FNA has a higher accuracy for diagnosing PCLs compared with cross-sectional imaging.
- Conditions
- Pancreatic Cyst, Pancreatic Neuroendocrine Carcinoma, Pancreatic Pseudocyst, Pancreatic Serous Cystadenoma, Pancreatic Mucinous Cystadenoma, Pancreatic Cystadenocarcinoma
- Keywords
- Endoscopic ultrasound, Radiology, Accuracy, Pancreatic Cyst, Pancreatic Cystadenocarcinoma, Pancreatic Mucinous Cystadenoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Pancreatic Serous Cystadenoma, Pancreatic Pseudocyst, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the Pancreas
- Medical subject headings
- Pancreatic Cyst, Somatostatinoma, Pancreatic Pseudocyst, Pancreatic Intraductal Neoplasms, Adenoma, Islet Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of EUS-FNA vs Radiology
To compare the accuracy of EUS-FNA(morphology, cytology, CEA(ng/ml)) with CT/MRI in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard Established CEA cut-offs of >192 ng/ml were used for mucinous assessment and >1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst
Measured: 10 years
Secondary outcomes (3)
Accuracy of EUS-FNA vs morphology
To compare the accuracy of EUS-FNA(morphology, cytology, CEA(ng/ml)) with EUS morphology alone in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard.Established CEA cut-offs of >192 ng/ml were used for mucinous assessment and >1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst
Measured: 10 years
Accuracy of EUS FNA vs cytology
To compare the accuracy of EUS-FNA(morphology, cytology, CEA (ng/ml)) with EUS cytology alone in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard.Established CEA cut-offs of >192 ng/ml were used for mucinous assessment and >1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst
Measured: 10 years
Accuracy of EUS FNA vs CEA
To compare the accuracy of EUS-FNA(morphology, cytology, CEA (ng/ml)) with EUS CEA(ng/ml) alone in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard.Established CEA cut-offs of >192 ng/ml were used for mucinous assessment and >1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Feb 2007
- Primary completion1 Dec 2017
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Sadik, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884179
- Sponsor's protocol ID
- SahlgrenskaUHGEA2017
- Status last verified
- Mar 2019
- First submitted
- 24 Apr 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Pancreatic Cystic Lesions With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy
- ClinicalTrials.gov ID
- NCT03884179
- Acronym / sponsor ID
- SahlgrenskaUHGEA2017
- Conditions
- Pancreatic Cyst, Pancreatic Neuroendocrine Carcinoma, Pancreatic Pseudocyst, Pancreatic Serous Cystadenoma, Pancreatic Mucinous Cystadenoma, Pancreatic Cystadenocarcinoma
- Keywords
- Endoscopic ultrasound, Radiology, Accuracy, Pancreatic Cyst, Pancreatic Cystadenocarcinoma, Pancreatic Mucinous Cystadenoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Pancreatic Serous Cystadenoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2007 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 21 Mar 2019 (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.
Pancreatic cystic lesions (PCLs) comprise of a heterogeneous group of entities that are benign, premalignant or malignant. With increased use of modern imaging techniques in recent years, incidentally discovered PCL have become much more common. However, imaging modalities for characterising PCL is a known clinical uncertainty since imaging is capable of detecting these lesions but may often not be able to distinguish malignant from benign lesions. Incorrect assessment of PCL can lead to fatal consequences because a malignant lesion may not be treated and a benign may be unnecessarily resected. The aim of this study was to assess the performance of endoscopic ultrasound with fine-needle aspiration (EUS-FNA) in the diagnosis of pancreatic cystic lesions compared to cross-sectional imaging modalities (CT/MRI). Our hypothesis is that EUS-FNA has a higher accuracy for diagnosing PCLs compared with cross-sectional imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017. The catchemnt area of this cente has a population of about two million.
Key inclusion criteria (2 listed)
- Patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017, who underwent pancreas resection
- Oral and written consent of patients examined
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of EUS-FNA vs Radiology
Time frame: 10 years
To compare the accuracy of EUS-FNA(morphology, cytology, CEA(ng/ml)) with CT/MRI in the diagnosis of pancreatic cystic lesions. Surgical pathology is used as gold standard Established CEA cut-offs of >192 ng/ml were used for mucinous assessment and >1000 ng/ml for established cancer assessment. A CEA value of 5 ng/ml or less was indicative of a serous cyst
3 secondary outcomes
Accuracy of EUS-FNA vs morphology
Time frame: 10 years
Accuracy of EUS FNA vs cytology
Time frame: 10 years
Accuracy of EUS FNA vs CEA
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cyst and Pancreatic Neuroendocrine Carcinoma, run by Sahlgrenska University Hospital.
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 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 21 Mar 2019. 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?
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?
Accuracy of EUS-FNA vs Radiology (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2019.