Clinical trial NCT02422095: Registry of Pancreatic Fluid Collections and Pancreatic Cysts
Official title: Registry of Endoscopic Ultrasound (EUS) Evaluation and Management of Pancreatic Fluid Collections and Pancreatic Cysts
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pancreatic Fluid Collections
Pancreatic Cyst
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients aged 18 years or over undergoing EUS evaluation of pancreatic cyst lesions or endoscopy-based (EUS-guided) interventions of pancreatic fluid collections.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment success in patients with pancreatic fluid collections following endoscopic interventions
timeFrame: 6 months (minimum)
measure: Natural history and disease progression in pancreatic cysts
timeFrame: 6 months (minimum) to 5 years
Secondary outcomes:
measure: Number of interventions required for treatment success in patients with pancreatic fluid collections
timeFrame: 6 months (minimum)
measure: Treatment failure in patients with pancreatic fluid collections
timeFrame: 6 months (minimum) to 5 years
measure: Adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections
timeFrame: 6 months (minimum) to 5 years
measure: Impact of disconnected pancreatic duct syndrome in patients undergoing EUS-guided drainage of pancreatic fluid collections
timeFrame: 6 months (minimum) to 5 years
measure: Impact of placement of long-term plastic transmural stents in patients with pancreatic fluid collections and disconnected pancreatic duct syndrome
timeFrame: 6 months (minimum) to 5 years
measure: Treatment success in patients with pancreatic fluid collections undergoing a structured approach to endoscopic necrosectomy following EUS-guided drainage of pancreatic fluid collections
timeFrame: 6 months (minimum) to 5 years
measure: Hospital admissions and reinterventions in patients undergoing EUS-guided drainage of pancreatic fluid collections
timeFrame: 6 months (minimum) to 5 years
measure: Recurrence of pancreatic fluid collections in patients undergoing EUS-guided drainage of pancreatic fluid collections
timeFrame: 6 months (minimum) to 5 years
measure: Evaluate the role of plastic stents in patients undergoing EUS-guided drainage of pancreatic fluid collections.
timeFrame: 6 months (minimum) to 5 years
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: Florida Hospital Center for Interventional Endoscopy
name: Muhammad Hasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bang JY, Mel Wilcox C, Arnoletti JP, Varadarajulu S. Importance of Disconnected Pancreatic Duct Syndrome in Recurrence of Pancreatic Fluid Collections Initially Drained Using Lumen-Apposing Metal Stents. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1275-1281.e2. doi: 10.1016/j.cgh.2020.07.022. Epub 2020 Jul 16.
citation: Bang JY, Hawes RH, Varadarajulu S. Lumen-apposing metal stent placement for drainage of pancreatic fluid collections: predictors of adverse events. Gut. 2020 Aug;69(8):1379-1381. doi: 10.1136/gutjnl-2019-320539. Epub 2020 Feb 17. No abstract available.