Acute PancreatitisNCT06179459
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
An observational study of Acute Pancreatitis and Pancreatic Pseudocyst, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Pancreatic Pseudocyst, Pancreatic Necrosis
- What is being tested?
- Endoscopic management of pancreatic fluid collections
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with pancreatic fluid collections
Who may be able to join
- Age ≥ 18 years
- All patients undergoing endoscopic treatment of pancreatic fluid collections
Who cannot join
- Age < 18 years
- Patients who did not receive endoscopic treatment of pancreatic fluid collections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orlando Health
Orlando, Florida, 21806
Ji Young Bang, 321-841-2431, jiyoung.bang@orlandohealth.com
Barbara J Broome, 321-841-4356, barbara.broome@orlandohealth.com
About this study
Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.
Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
Read the detailed description
Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.
Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. Endoscopic treatment involves the drainage of the fluid collection into the stomach or duodenum by placement of metal or plastic stents. If clinically indicated, endoscopic necrosectomy is also performed, which is the removal of devitalized pancreatic tissue using the endoscope. Currently the treatment success rate of endoscopic treatment of pancreatic fluid collections exceeds 90%.
The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
- Being tested
- Endoscopic management of pancreatic fluid collections
- Medical subject headings
- Pancreatitis, Pancreatic Pseudocyst, Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic management of pancreatic fluid collectionsProcedure or surgery
Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections according to timing of treatment.
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections is assessed as a composite measure consisting of 1) adverse events or 2) need for hospital admission due to underlying disease or procedure-related adverse events, in patients undergoing endoscopic treatment of pancreatic fluid collections, according to timing of treatment.
Measured: 6 months
Secondary outcomes (16)
Treatment success
Rate of treatment success, defined as the resolution of pancreatic fluid collection on CT scan in association with clinical resolution of symptoms at 6-months from index intervention.
Measured: 6 months
Number and type of interventions performed
Number of interventions performed to achieve treatment success
Measured: 6 months
Need for surgical intervention
Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections.
Measured: 6 months
Technical success of endoscopic interventions in pancreatic fluid collections.
Technical success of endoscopic interventions in pancreatic fluid collections.
Measured: 6 months
Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.
Rate of inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.
Measured: 6 months
Disease-related adverse events
Rate of disease-related adverse events
Measured: 6 monthts
Procedure-related adverse events
Procedure-related adverse events in patients undergoing endoscopic management of pancreatic fluid collection
Measured: 6 months
Timing of intervention
Intervention at 4 weeks since onset of pancreatitis (traditional approach) versus intervention when the area of necrosis is contained or only partially encapsulated.
Measured: 6 months
Hounsfield units of the pancreatic fluid collection
Impact of hounsfield units in the necrotic collection on endoscopic intervention
Measured: 6 months
Impact of partial versus full encapsulation of pancreatic fluid collections
Impact of partial versus full encapsulation of pancreatic fluid collections on endoscopic intervention
Measured: 6 months
Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome
Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome
Measured: 6 months
Hospital admission
Rate of hospital readmissions due to disease-related or procedure-related events in patients undergoing endoscopic therapy for pancreatic fluid collections.
Measured: 6 months
Disease recurrence
Rate of disease recurrence in patients undergoing endoscopic management of pancreatic fluid collections
Measured: 6 months
Diabetes
Rate of diabetes
Measured: 6 months
Exocrine pancreatic insufficiency
Rate of exocrine pancreatic insufficiency
Measured: 6 months
Treatment costs
Treatment costs from admission until hospital discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 May 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Young Bang, MD MPH, Principal investigator, Orlando Health, Digestive Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179459
- Sponsor's protocol ID
- 22.060.03
- Status last verified
- Jul 2026
- First submitted
- 12 Dec 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
- ClinicalTrials.gov ID
- NCT06179459
- Acronym / sponsor ID
- 22.060.03
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Dec 2023 (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.
Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.
Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
Detailed description
Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.
Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. Endoscopic treatment involves the drainage of the fluid collection into the stomach or duodenum by placement of metal or plastic stents. If clinically indicated, endoscopic necrosectomy is also performed, which is the removal of devitalized pancreatic tissue using the endoscope. Currently the treatment success rate of endoscopic treatment of pancreatic fluid collections exceeds 90%.
The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic fluid collections
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- All patients undergoing endoscopic treatment of pancreatic fluid collections
Key exclusion criteria (2 listed)
- Age < 18 years
- Patients who did not receive endoscopic treatment of pancreatic fluid collections
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 |
|---|---|---|
| Endoscopic management of pancreatic fluid collectionsPatients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy | Procedure or surgery | – |
Primary outcome
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections according to timing of treatment.
Time frame: 6 months
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections is assessed as a composite measure consisting of 1) adverse events or 2) need for hospital admission due to underlying disease or procedure-related adverse events, in patients undergoing endoscopic treatment of pancreatic fluid collections, according to timing of treatment.
16 secondary outcomes
Treatment success
Time frame: 6 months
Number and type of interventions performed
Time frame: 6 months
Need for surgical intervention
Time frame: 6 months
Technical success of endoscopic interventions in pancreatic fluid collections.
Time frame: 6 months
Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.
Time frame: 6 months
Disease-related adverse events
Time frame: 6 monthts
Procedure-related adverse events
Time frame: 6 months
Timing of intervention
Time frame: 6 months
Hounsfield units of the pancreatic fluid collection
Time frame: 6 months
Impact of partial versus full encapsulation of pancreatic fluid collections
Time frame: 6 months
Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome
Time frame: 6 months
Hospital admission
Time frame: 6 months
Disease recurrence
Time frame: 6 months
Diabetes
Time frame: 6 months
Exocrine pancreatic insufficiency
Time frame: 6 months
Treatment costs
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Ji Young Bang, MD MPH principal investigator
Orlando Health, Digestive Health Institute
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 Acute Pancreatitis and Pancreatic Pseudocyst, run by Orlando Health, Inc. 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 2 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji Young Bang (321-841-2431, jiyoung.bang@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections according to timing of treatment. (time frame: 6 months). 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 9 Jul 2026.