- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2021-05-01
2032-12
2032-12
1000
NCT06179459
Orlando Health, Inc.
Orlando Health, Inc.
OBSERVATIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-12-12 | N/A | 2024-01-29 |
2023-12-12 | N/A | 2024-01-31 |
2023-12-21 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections. | Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections. | 3 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Number and type of interventions performed | Number of interventions performed to achieve treatment success | 6 months |
| Need for surgical intervention | Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections. | 6 months |
| Technical success of endoscopic interventions in pancreatic fluid collections. | Technical success of endoscopic interventions in pancreatic fluid collections. | 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. | 6 months |
| Disease-related adverse events | Rate of disease-related adverse events | 6 monthts |
| Procedure-related adverse events | Procedure-related adverse events in patients undergoing endoscopic management of pancreatic fluid collection | 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 | 3 years |
| Hospital admission | Rate of hospital readmissions due to disease-related or procedure-related events in patients undergoing endoscopic therapy for pancreatic fluid collections. | 6 months |
| Disease recurrence | Rate of disease recurrence in patients undergoing endoscopic management of pancreatic fluid collections | 3 years |
| Diabetes | Rate of diabetes | 3 years |
| Exocrine pancreatic insufficiency | Rate of exocrine pancreatic insufficiency | 3 years |
| 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. | 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Ji Young Bang Phone Number: 321-841-2431 Email: jiyoung.bang@orlandohealth.com |
Study Contact Backup Name: Barbara J Broome Phone Number: 321-841-4356 Email: barbara.broome@orlandohealth.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
