Registry of Pancreatic Fluid Collections and Pancreatic Cysts

Withdrawn

• Conditions: Pancreatic Cyst; Pancreatic Fluid Collections
• Interventions: Procedure: EUS of pancreatic cysts; Procedure: Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections

• Registration Number: NCT02422095
• Lead Sponsor: AdventHealth

Brief Summary

This registry aims to assess the outcomes of patients undergoing EUS-guided interventions of pancreatic fluid collections and EUS examination of pancreatic cyst lesions.

Detailed Description

For pancreatic fluid collections, data included in this registry are 292 variables on patient demographics (age, gender, race), symptoms at presentation, severity of disease prior to intervention, indications for undergoing endoscopic intervention, details of the pancreatic fluid collections on cross-sectional imaging and EUS, review of laboratory results, review of imaging, details of interventions performed for pancreatic fluid collections, clinical details following intervention, adverse events from interventions and pancreatitis/pancreatic fluid collections, interventions for any adverse events, response to treatment of pancreatic fluid collections including any hospital readmissions, recurrence of pancreatic fluid collections, need for repeat interventions for pancreatic fluid collections, details of pancreatic duct integrity such as the presence of disconnected pancreatic duct syndrome, and clinical status at follow-up.

For pancreatic cysts, data included in this registry are 60 variables on patient demographics (age, gender, race), symptoms at presentation, imaging modality performed to detect the cyst, features of the cyst on EUS, features of the main pancreatic duct on EUS, technical details of EUS-guided sampling of the cystic fluid, results of cyst fluid analysis including cytology, tumor markers, amylase levels, molecular markers, final diagnosis of the cyst on follow-up, details of any follow up evaluation performed, details of repeat examinations performed and details of any treatment performed for the pancreatic cyst.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-21
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. All patients aged 18 years or over, who are undergoing EUS evaluation of a pancreatic cyst lesion or endoscopy-based (EUS-guided) interventions for pancreatic fluid collection at the Center for Interventional Endoscopy will be included in this registry.

Exclusion Criteria

1. Age less than 18 years
2. No pancreatic cyst on EUS examination or no pancreatic fluid collection amenable to endoscopic drainage on EUS examination

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatic cysts	EUS of pancreatic cysts	Patients with pancreatic cysts undergoing EUS examination and possible EUS-guided sampling of cystic fluid.
Pancreatic fluid collections	Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections	Patients with pancreatic fluid collections undergoing endoscopy-based (EUS-guided) interventions

Primary Outcome Measures

Name	Time	Method
Treatment success in patients with pancreatic fluid collections following endoscopic interventions	6 months (minimum)	The treatment success of a structured, algorithmic approach to the management of pancreatic fluid collections will be evaluated. Structured approach involves management strategies based on the type (pseudocyst vs. necrosis), size, number, location of the pancreatic fluid collection, degree of necrosis, need for adjunctive percutaneous drain placement, and presence of disconnected pancreatic duct syndrome.
Natural history and disease progression in pancreatic cysts	6 months (minimum) to 5 years	The relationship between patient characteristics, clinical symptoms, cyst and pancreatic duct characteristics on cross-sectional imaging and on EUS examination, results of cyst sampling (including cytology, tumor markers, amylase, molecular markers) and final diagnosis on follow-up with be determined.

Secondary Outcome Measures

Name	Time	Method
Number of interventions required for treatment success in patients with pancreatic fluid collections	6 months (minimum)	The total number of procedures (including transmural drainage and endoscopic necrosectomy) required to achieve treatment success (defined as resolution of symptoms and fluid collection on imaging) in patients with pancreatic fluid collections at 6 months follow up.
Treatment failure in patients with pancreatic fluid collections	6 months (minimum) to 5 years	The rate of failure (defined as need for rescue surgery or death due to underlying disease or intervention) of EUS-guided treatment of pancreatic fluid collections will be assessed
Adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections	6 months (minimum) to 5 years	The rate and type of adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections will be assessed
Impact of disconnected pancreatic duct syndrome in patients undergoing EUS-guided drainage of pancreatic fluid collections	6 months (minimum) to 5 years	The impact of disconnected pancreatic duct syndrome in patients undergoing EUS-guided drainage of pancreatic fluid collections on treatment success and disease recurrence will be assessed.
Impact of placement of long-term plastic transmural stents in patients with pancreatic fluid collections and disconnected pancreatic duct syndrome	6 months (minimum) to 5 years	The impact of placement of long-term plastic transmural stents in patients with pancreatic fluid collections and disconnected pancreatic duct syndrome will be assessed.
Treatment success in patients with pancreatic fluid collections undergoing a structured approach to endoscopic necrosectomy following EUS-guided drainage of pancreatic fluid collections	6 months (minimum) to 5 years	The treatment success of a structured approach endoscopic necrosectomy following EUS-guided drainage of pancreatic fluid collections will be assessed. The structured approach to endoscopic necrosectomy involves three steps - debridement, extraction and irrigation.
Recurrence of pancreatic fluid collections in patients undergoing EUS-guided drainage of pancreatic fluid collections	6 months (minimum) to 5 years	The rate of recurrence of pancreatic fluid collections in patients undergoing EUS-guided drainage of pancreatic fluid collections will be assessed
Hospital admissions and reinterventions in patients undergoing EUS-guided drainage of pancreatic fluid collections	6 months (minimum) to 5 years	The number of hospital admissions and reinterventions in patients undergoing EUS-guided drainage of pancreatic fluid collections will be assessed
Evaluate the role of plastic stents in patients undergoing EUS-guided drainage of pancreatic fluid collections.	6 months (minimum) to 5 years	Evaluate the role of plastic stents in the era of LAMS specifically pertaining to a) exchange of LAMS for plastic stents in patients with disconnected pancreatic duct syndrome after PFC resolution and b) use of plastic stents as the primary mode of drainage in patients with pseudocysts and obstructive/disconnecte main pancreatic duct.

Trial Locations

Locations (1)

Florida Hospital; 🇺🇸 Orlando, Florida, United States