Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

NCT ID: NCT06179459

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2032-12-31

Brief Summary

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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

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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.

Conditions

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Acute Pancreatitis Pancreatic Pseudocyst Pancreatic Necrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endoscopic management of pancreatic fluid collections

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orlando Health, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ji Young Bang, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Orlando Health, Digestive Health Institute

Locations

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Orlando Health

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ji Young Bang

Role: CONTACT

321-841-2431

Barbara J Broome

Role: CONTACT

321-841-4356

Facility Contacts

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Ji Young Bang

Role: primary

321-841-2431

Barbara J Broome

Role: backup

321-841-4356

Other Identifiers

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22.060.03

Identifier Type: -

Identifier Source: org_study_id

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