Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06179459

Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Pancreatitis Cysts Digestive System Diseases Neoplasms Pancreatic Cyst Pancreatic Diseases Pancreatic Necrosis Pancreatic Pseudocyst Pancreatitis Pancreatitis, Acute Necrotizing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • All patients undergoing endoscopic treatment of pancreatic fluid collections

Exclusion criteria

  • Age < 18 years
  • Patients who did not receive endoscopic treatment of pancreatic fluid collections

Treatment and study plan

Endoscopic management of pancreatic fluid collections

Procedure

Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Treatment success

    Time frame: 6 months

    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.

  2. Number and type of interventions performed

    Time frame: 6 months

    Number of interventions performed to achieve treatment success

  3. Need for surgical intervention

    Time frame: 6 months

    Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections.

  4. Technical success of endoscopic interventions in pancreatic fluid collections.

    Time frame: 6 months

    Technical success of endoscopic interventions in pancreatic fluid collections.

  5. Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.

    Time frame: 6 months

    Rate of inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.

  6. Disease-related adverse events

    Time frame: 6 monthts

    Rate of disease-related adverse events

  7. Procedure-related adverse events

    Time frame: 6 months

    Procedure-related adverse events in patients undergoing endoscopic management of pancreatic fluid collection

  8. Timing of intervention

    Time frame: 6 months

    Intervention at 4 weeks since onset of pancreatitis (traditional approach) versus intervention when the area of necrosis is contained or only partially encapsulated.

  9. Hounsfield units of the pancreatic fluid collection

    Time frame: 6 months

    Impact of hounsfield units in the necrotic collection on endoscopic intervention

  10. Impact of partial versus full encapsulation of pancreatic fluid collections

    Time frame: 6 months

    Impact of partial versus full encapsulation of pancreatic fluid collections on endoscopic intervention

  11. Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome

    Time frame: 6 months

    Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome

  12. Hospital admission

    Time frame: 6 months

    Rate of hospital readmissions due to disease-related or procedure-related events in patients undergoing endoscopic therapy for pancreatic fluid collections.

  13. Disease recurrence

    Time frame: 6 months

    Rate of disease recurrence in patients undergoing endoscopic management of pancreatic fluid collections

  14. Diabetes

    Time frame: 6 months

    Rate of diabetes

  15. Exocrine pancreatic insufficiency

    Time frame: 6 months

    Rate of exocrine pancreatic insufficiency

  16. Treatment costs

    Time frame: 6 months

    Treatment costs from admission until hospital discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara J Broome

CONTACT

[email protected]

321-841-4356

Ji Young Bang

CONTACT

[email protected]

321-841-2431

Sponsors and collaborators

Lead sponsor

Orlando Health, Inc.

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 21, 2023
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.