Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179459
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-12-12
Brief Title:
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
Sponsor:
Orlando Health Inc
Organization:
Orlando Health Inc
Study Overview
Official Title:
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 100000 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 25 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None