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WithdrawnNCT02422095Updated Jun 28, 2023

Registry of Pancreatic Fluid Collections and Pancreatic Cysts

An observational study in Pancreatic Fluid Collections and Pancreatic Cyst, sponsored by AdventHealth. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.

Sponsored by AdventHealth · Observational

Why this study was withdrawn
This is project was determined to be not research, and the IRB has no oversight

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 54 studies in Pancreatic Cyst with a site in United States — 20 open to participants now, 23 under way, 1 of them phase 3. Pancreatic Cyst · United States.

Enrollment
32nd of 32
0 · median 300
Started
2015
with 2 others
Observational
32 of 54
12 open now
Registered
20th of 54
by date
Lead sponsor
2 of 54
AdventHealth

Among the 54 studies in Pancreatic Cyst with a site in United States, this one is the 32nd largest by enrollment of the 32 observational ones that give a count, is one of 3 that started in 2015, is one of 32 observational ones, and was the 20th registered.

Pancreatic Cyst

97 studies on the registry are indexed under Pancreatic Cyst; 37 are open to participants now.

Browse Pancreatic Cyst studies →

Open to participants now

20 of the 54 studies in Pancreatic Cyst with a site in United States are open now. Recruiting first, the newest first:

15 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 33 Pancreatic Cyst studies recruiting now, 25 (76%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Pancreatic Fluid Collections
  • Pancreatic Cyst

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  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.

Exclusion criteria

Exclusion Criteria

  1. Age less than 18 years
  2. No pancreatic cyst on EUS examination or no pancreatic fluid collection amenable to endoscopic drainage on EUS examination
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Pancreatic fluid collections

    Patients with pancreatic fluid collections undergoing endoscopy-based (EUS-guided) interventions

    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.

    Procedure: EUS of pancreatic cysts

Interventions

  • ProcedureEndoscopy-based (EUS-guided) interventions for pancreatic fluid collections

    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.

  • ProcedureEUS of pancreatic cysts

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months (minimum)

  2. 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.

    Time frame: 6 months (minimum) to 5 years

Secondary outcomes

  1. 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.

    Time frame: 6 months (minimum)

  2. 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

    Time frame: 6 months (minimum) to 5 years

  3. 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

    Time frame: 6 months (minimum) to 5 years

  4. 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.

    Time frame: 6 months (minimum) to 5 years

  5. 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.

    Time frame: 6 months (minimum) to 5 years

  6. 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.

    Time frame: 6 months (minimum) to 5 years

  7. 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

    Time frame: 6 months (minimum) to 5 years

  8. 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

    Time frame: 6 months (minimum) to 5 years

  9. 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.

    Time frame: 6 months (minimum) to 5 years

07

Study locations

1 site
  • Florida Hospital
    Orlando, Florida 32803, United States
08

References and documents

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 32683101 ↗
  • Bang 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 ↗

Individual participant data

Plan to share: No — A manuscript will be developed following study closure.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2015, a primary completion of Dec 2025 and a completion of Dec 2025. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2015
First posted
Apr 21, 2015
Start
Feb 2015
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Jun 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02422095
Lead sponsor
AdventHealth
Responsible party
Sponsor
First posted
Apr 21, 2015
Start date
Feb 2015
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jun 28, 2023

Study contacts

Muhammad Hasan, MD
principal investigator · Florida Hospital Center for Interventional Endoscopy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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