Pancreatic Fluid CollectionsNCT02422095
Registry of Pancreatic Fluid Collections and Pancreatic Cysts
An observational study of Pancreatic Fluid Collections and Pancreatic Cyst, run by AdventHealth at 1 site in United States.
Trial summary
This registry aims to assess the outcomes of patients undergoing EUS-guided interventions of pancreatic fluid collections and EUS examination of pancreatic cyst lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fluid Collections, Pancreatic Cyst
- What is being tested?
- Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections and EUS of pancreatic cysts
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2025
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged 18 years or over undergoing EUS evaluation of pancreatic cyst lesions or endoscopy-based (EUS-guided) interventions of pancreatic fluid collections.
Who may be able to join
- 1. All patients aged 18 years or over, who are undergoing EUS evaluation of a pancreatic cyst lesion or endoscopy-based (EUS-guided) interventions for pancreatic fluid collection at the Center for Interventional Endoscopy will be included in this registry.
Who cannot join
- Age less than 18 years
- No pancreatic cyst on EUS examination or no pancreatic fluid collection amenable to endoscopic drainage on EUS examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registry of Endoscopic Ultrasound (EUS) Evaluation and Management of Pancreatic Fluid Collections and Pancreatic Cysts
This registry aims to assess the outcomes of patients undergoing EUS-guided interventions of pancreatic fluid collections and EUS examination of pancreatic cyst lesions.
Read the detailed description
For pancreatic fluid collections, data included in this registry are 292 variables on patient demographics (age, gender, race), symptoms at presentation, severity of disease prior to intervention, indications for undergoing endoscopic intervention, details of the pancreatic fluid collections on cross-sectional imaging and EUS, review of laboratory results, review of imaging, details of interventions performed for pancreatic fluid collections, clinical details following intervention, adverse events from interventions and pancreatitis/pancreatic fluid collections, interventions for any adverse events, response to treatment of pancreatic fluid collections including any hospital readmissions, recurrence of pancreatic fluid collections, need for repeat interventions for pancreatic fluid collections, details of pancreatic duct integrity such as the presence of disconnected pancreatic duct syndrome, and clinical status at follow-up.
For pancreatic cysts, data included in this registry are 60 variables on patient demographics (age, gender, race), symptoms at presentation, imaging modality performed to detect the cyst, features of the cyst on EUS, features of the main pancreatic duct on EUS, technical details of EUS-guided sampling of the cystic fluid, results of cyst fluid analysis including cytology, tumor markers, amylase levels, molecular markers, final diagnosis of the cyst on follow-up, details of any follow up evaluation performed, details of repeat examinations performed and details of any treatment performed for the pancreatic cyst.
- Conditions
- Pancreatic Fluid Collections, Pancreatic Cyst
- Being tested
- Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections, EUS of pancreatic cysts
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy-based (EUS-guided) interventions for pancreatic fluid collectionsProcedure or surgery
Data included are patient demographics, symptoms, disease severity, procedural indications, details of the pancreatic fluid collection on cross-sectional imaging/EUS, review of laboratory results/imaging, details of interventions, clinical response to intervention, adverse events from interventions and pancreatitis/pancreatic fluid collections, response to treatment including any recurrent hospital admissions, recurrence of pancreatic fluid collections, need for repeat interventions, details of pancreatic duct integrity (e.g. presence of disconnected pancreatic duct syndrome), and clinical status at follow-up.
EUS of pancreatic cystsProcedure or surgery
Data included are patient demographics (age, gender, race), symptoms at presentation, imaging modality performed to detect the cyst, cyst features on EUS, technical details of EUS-guided sampling, results of cyst fluid analysis, final diagnosis, any follow up and repeat examinations and details of any treatment performed.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic fluid collections | Patients with pancreatic fluid collections undergoing endoscopy-based (EUS-guided) interventions Receives: Procedure: Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections | |
| Pancreatic cysts | Patients with pancreatic cysts undergoing EUS examination and possible EUS-guided sampling of cystic fluid. Receives: Procedure: EUS of pancreatic cysts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success in patients with pancreatic fluid collections following endoscopic interventions
The treatment success of a structured, algorithmic approach to the management of pancreatic fluid collections will be evaluated. Structured approach involves management strategies based on the type (pseudocyst vs. necrosis), size, number, location of the pancreatic fluid collection, degree of necrosis, need for adjunctive percutaneous drain placement, and presence of disconnected pancreatic duct syndrome.
Measured: 6 months (minimum)
Natural history and disease progression in pancreatic cysts
The relationship between patient characteristics, clinical symptoms, cyst and pancreatic duct characteristics on cross-sectional imaging and on EUS examination, results of cyst sampling (including cytology, tumor markers, amylase, molecular markers) and final diagnosis on follow-up with be determined.
Measured: 6 months (minimum) to 5 years
Secondary outcomes (9)
Number of interventions required for treatment success in patients with pancreatic fluid collections
The total number of procedures (including transmural drainage and endoscopic necrosectomy) required to achieve treatment success (defined as resolution of symptoms and fluid collection on imaging) in patients with pancreatic fluid collections at 6 months follow up.
Measured: 6 months (minimum)
Treatment failure in patients with pancreatic fluid collections
The rate of failure (defined as need for rescue surgery or death due to underlying disease or intervention) of EUS-guided treatment of pancreatic fluid collections will be assessed
Measured: 6 months (minimum) to 5 years
Adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections
The rate and type of adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections will be assessed
Measured: 6 months (minimum) to 5 years
Impact of disconnected pancreatic duct syndrome in patients undergoing EUS-guided drainage of pancreatic fluid collections
The impact of disconnected pancreatic duct syndrome in patients undergoing EUS-guided drainage of pancreatic fluid collections on treatment success and disease recurrence will be assessed.
Measured: 6 months (minimum) to 5 years
Impact of placement of long-term plastic transmural stents in patients with pancreatic fluid collections and disconnected pancreatic duct syndrome
The impact of placement of long-term plastic transmural stents in patients with pancreatic fluid collections and disconnected pancreatic duct syndrome will be assessed.
Measured: 6 months (minimum) to 5 years
Treatment success in patients with pancreatic fluid collections undergoing a structured approach to endoscopic necrosectomy following EUS-guided drainage of pancreatic fluid collections
The treatment success of a structured approach endoscopic necrosectomy following EUS-guided drainage of pancreatic fluid collections will be assessed. The structured approach to endoscopic necrosectomy involves three steps - debridement, extraction and irrigation.
Measured: 6 months (minimum) to 5 years
Hospital admissions and reinterventions in patients undergoing EUS-guided drainage of pancreatic fluid collections
The number of hospital admissions and reinterventions in patients undergoing EUS-guided drainage of pancreatic fluid collections will be assessed
Measured: 6 months (minimum) to 5 years
Recurrence of pancreatic fluid collections in patients undergoing EUS-guided drainage of pancreatic fluid collections
The rate of recurrence of pancreatic fluid collections in patients undergoing EUS-guided drainage of pancreatic fluid collections will be assessed
Measured: 6 months (minimum) to 5 years
Evaluate the role of plastic stents in patients undergoing EUS-guided drainage of pancreatic fluid collections.
Evaluate the role of plastic stents in the era of LAMS specifically pertaining to a) exchange of LAMS for plastic stents in patients with disconnected pancreatic duct syndrome after PFC resolution and b) use of plastic stents as the primary mode of drainage in patients with pseudocysts and obstructive/disconnecte main pancreatic duct.
Measured: 6 months (minimum) to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: This is project was determined to be not research, and the IRB has no oversight
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 Fluid CollectionsStudies 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
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Hasan, MD, Principal investigator, Florida Hospital Center for Interventional Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422095
- Sponsor's protocol ID
- 700323
- Other IDs
- 1108594
- Status last verified
- Jun 2023
- First submitted
- 23 Feb 2015
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: A manuscript will be developed following study closure.
Publications
Bang JY, Mel Wilcox C, Arnoletti JP, Varadarajulu S. Importance of Disconnected Pancreatic Duct Syndrome in Recurrence of Pancreatic Fluid Collections Initially Drained Using Lumen-Apposing Metal Stents. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1275-1281.e2. doi: 10.1016/j.cgh.2020.07.022. Epub 2020 Jul 16.
PubMed 32683101Bang JY, Hawes RH, Varadarajulu S. Lumen-apposing metal stent placement for drainage of pancreatic fluid collections: predictors of adverse events. Gut. 2020 Aug;69(8):1379-1381. doi: 10.1136/gutjnl-2019-320539. Epub 2020 Feb 17. No abstract available.
PubMed 32066622
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Endoscopic Ultrasound (EUS) Evaluation and Management of Pancreatic Fluid Collections and Pancreatic Cysts
- ClinicalTrials.gov ID
- NCT02422095
- Acronym / sponsor ID
- 700323
- Conditions
- Pancreatic Fluid Collections, Pancreatic Cyst
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This is project was determined to be not research, and the IRB has no oversight
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Apr 2015 (estimated)
- 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.
This registry aims to assess the outcomes of patients undergoing EUS-guided interventions of pancreatic fluid collections and EUS examination of pancreatic cyst lesions.
Detailed description
For pancreatic fluid collections, data included in this registry are 292 variables on patient demographics (age, gender, race), symptoms at presentation, severity of disease prior to intervention, indications for undergoing endoscopic intervention, details of the pancreatic fluid collections on cross-sectional imaging and EUS, review of laboratory results, review of imaging, details of interventions performed for pancreatic fluid collections, clinical details following intervention, adverse events from interventions and pancreatitis/pancreatic fluid collections, interventions for any adverse events, response to treatment of pancreatic fluid collections including any hospital readmissions, recurrence of pancreatic fluid collections, need for repeat interventions for pancreatic fluid collections, details of pancreatic duct integrity such as the presence of disconnected pancreatic duct syndrome, and clinical status at follow-up.
For pancreatic cysts, data included in this registry are 60 variables on patient demographics (age, gender, race), symptoms at presentation, imaging modality performed to detect the cyst, features of the cyst on EUS, features of the main pancreatic duct on EUS, technical details of EUS-guided sampling of the cystic fluid, results of cyst fluid analysis including cytology, tumor markers, amylase levels, molecular markers, final diagnosis of the cyst on follow-up, details of any follow up evaluation performed, details of repeat examinations performed and details of any treatment performed for the pancreatic cyst.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic fluid collections | – | Procedure: Endoscopy-based (EUS-guided) interventions for pancreatic fluid collectionsPatients with pancreatic fluid collections undergoing endoscopy-based (EUS-guided) interventions |
| Pancreatic cysts | – | Procedure: EUS of pancreatic cystsPatients with pancreatic cysts undergoing EUS examination and possible EUS-guided sampling of cystic fluid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 years or over undergoing EUS evaluation of pancreatic cyst lesions or endoscopy-based (EUS-guided) interventions of pancreatic fluid collections.
Key inclusion criteria (1 listed)
- 1. All patients aged 18 years or over, who are undergoing EUS evaluation of a pancreatic cyst lesion or endoscopy-based (EUS-guided) interventions for pancreatic fluid collection at the Center for Interventional Endoscopy will be included in this registry.
Key exclusion criteria (2 listed)
- Age less than 18 years
- No pancreatic cyst on EUS examination or no pancreatic fluid collection amenable to endoscopic drainage on EUS examination
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 |
|---|---|---|
| Endoscopy-based (EUS-guided) interventions for pancreatic fluid collectionsData included are patient demographics, symptoms, disease severity, procedural indications, details of the pancreatic fluid collection on cross-sectional imaging/EUS, review of laboratory results/imaging, details of interventions, clinical response to intervention, adverse events from interventions and pancreatitis/pancreatic fluid collections, response to treatment including any recurrent hospital admissions, recurrence of pancreatic fluid collections, need for repeat interventions, details of pancreatic duct integrity (e.g. presence of disconnected pancreatic duct syndrome), and clinical status at follow-up. | Procedure or surgery | Pancreatic fluid collections |
| EUS of pancreatic cystsData included are patient demographics (age, gender, race), symptoms at presentation, imaging modality performed to detect the cyst, cyst features on EUS, technical details of EUS-guided sampling, results of cyst fluid analysis, final diagnosis, any follow up and repeat examinations and details of any treatment performed. | Procedure or surgery | Pancreatic cysts |
Primary outcome
Treatment success in patients with pancreatic fluid collections following endoscopic interventions
Time frame: 6 months (minimum)
The treatment success of a structured, algorithmic approach to the management of pancreatic fluid collections will be evaluated. Structured approach involves management strategies based on the type (pseudocyst vs. necrosis), size, number, location of the pancreatic fluid collection, degree of necrosis, need for adjunctive percutaneous drain placement, and presence of disconnected pancreatic duct syndrome.
Natural history and disease progression in pancreatic cysts
Time frame: 6 months (minimum) to 5 years
The relationship between patient characteristics, clinical symptoms, cyst and pancreatic duct characteristics on cross-sectional imaging and on EUS examination, results of cyst sampling (including cytology, tumor markers, amylase, molecular markers) and final diagnosis on follow-up with be determined.
9 secondary outcomes
Number of interventions required for treatment success in patients with pancreatic fluid collections
Time frame: 6 months (minimum)
Treatment failure in patients with pancreatic fluid collections
Time frame: 6 months (minimum) to 5 years
Adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections
Time frame: 6 months (minimum) to 5 years
Impact of disconnected pancreatic duct syndrome in patients undergoing EUS-guided drainage of pancreatic fluid collections
Time frame: 6 months (minimum) to 5 years
Impact of placement of long-term plastic transmural stents in patients with pancreatic fluid collections and disconnected pancreatic duct syndrome
Time frame: 6 months (minimum) to 5 years
Treatment success in patients with pancreatic fluid collections undergoing a structured approach to endoscopic necrosectomy following EUS-guided drainage of pancreatic fluid collections
Time frame: 6 months (minimum) to 5 years
Hospital admissions and reinterventions in patients undergoing EUS-guided drainage of pancreatic fluid collections
Time frame: 6 months (minimum) to 5 years
Recurrence of pancreatic fluid collections in patients undergoing EUS-guided drainage of pancreatic fluid collections
Time frame: 6 months (minimum) to 5 years
Evaluate the role of plastic stents in patients undergoing EUS-guided drainage of pancreatic fluid collections.
Time frame: 6 months (minimum) to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 32683101Bang JY, Mel Wilcox C, Arnoletti JP, Varadarajulu S. Importance of Disconnected Pancreatic Duct Syndrome in Recurrence of Pancreatic Fluid Collections Initially Drained Using Lumen-Apposing Metal Stents. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1275-1281.e2. doi: 10.1016/j.cgh.2020.07.022. Epub 2020 Jul 16.
- Derived from this study: PubMed 32066622Bang JY, Hawes RH, Varadarajulu S. Lumen-apposing metal stent placement for drainage of pancreatic fluid collections: predictors of adverse events. Gut. 2020 Aug;69(8):1379-1381. doi: 10.1136/gutjnl-2019-320539. Epub 2020 Feb 17. No abstract available.
- Individual participant dataSharing planned: No. A manuscript will be developed following study closure.
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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.
Muhammad Hasan, MD principal investigator
Florida Hospital Center for Interventional Endoscopy
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 Fluid Collections and Pancreatic Cyst, run by AdventHealth at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 28 Jun 2023. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Treatment success in patients with pancreatic fluid collections following endoscopic interventions (time frame: 6 months (minimum)). The study lists 2 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 NCT02422095, 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 28 Jun 2023.