Registry of Pancreatic Fluid Collections and Pancreatic Cysts

Registry of Endoscopic Ultrasound (EUS) Evaluation and Management of Pancreatic Fluid Collections and Pancreatic Cysts

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

Study Overview

• Status: Withdrawn
• Conditions: Pancreatic Cyst; Pancreatic Fluid Collections
• Intervention / Treatment: Procedure: Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections; Procedure: EUS of pancreatic cysts

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pancreatic fluid collections; Patients with pancreatic fluid collections undergoing endoscopy-based (EUS-guided) interventions	Procedure: Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections; Data included are patient demographics, symptoms, disease severity, procedural indications, details of the pancreatic fluid collection on cross-sectional imaging/EUS, review of laboratory results/imaging, details of interventions, clinical response to intervention, adverse events from interventions and pancreatitis/pancreatic fluid collections, response to treatment including any recurrent hospital admissions, recurrence of pancreatic fluid collections, need for repeat interventions, details of pancreatic duct integrity (e.g. presence of disconnected pancreatic duct syndrome), and clinical status at follow-up.
Pancreatic cysts; Patients with pancreatic cysts undergoing EUS examination and possible EUS-guided sampling of cystic fluid.	Procedure: EUS of pancreatic cysts; Data included are patient demographics (age, gender, race), symptoms at presentation, imaging modality performed to detect the cyst, cyst features on EUS, technical details of EUS-guided sampling, results of cyst fluid analysis, final diagnosis, any follow up and repeat examinations and details of any treatment performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success in patients with pancreatic fluid collections following endoscopic interventions	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.	6 months (minimum)
Natural history and disease progression in pancreatic cysts	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.	6 months (minimum) to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of interventions required for treatment success in patients with pancreatic fluid collections	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.	6 months (minimum)
Treatment failure in patients with pancreatic fluid collections	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	6 months (minimum) to 5 years
Adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections	The rate and type of adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections will be assessed	6 months (minimum) to 5 years
Impact of disconnected pancreatic duct syndrome in patients undergoing EUS-guided drainage of pancreatic fluid collections	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.	6 months (minimum) to 5 years
Impact of placement of long-term plastic transmural stents in patients with pancreatic fluid collections and disconnected pancreatic duct syndrome	The impact of placement of long-term plastic transmural stents in patients with pancreatic fluid collections and disconnected pancreatic duct syndrome will be assessed.	6 months (minimum) to 5 years
Treatment success in patients with pancreatic fluid collections undergoing a structured approach to endoscopic necrosectomy following EUS-guided drainage of pancreatic fluid collections	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.	6 months (minimum) to 5 years
Hospital admissions and reinterventions in patients undergoing EUS-guided drainage of pancreatic fluid collections	The number of hospital admissions and reinterventions in patients undergoing EUS-guided drainage of pancreatic fluid collections will be assessed	6 months (minimum) to 5 years
Recurrence of pancreatic fluid collections in patients undergoing EUS-guided drainage of pancreatic fluid collections	The rate of recurrence of pancreatic fluid collections in patients undergoing EUS-guided drainage of pancreatic fluid collections will be assessed	6 months (minimum) to 5 years
Evaluate the role of plastic stents in patients undergoing EUS-guided drainage of pancreatic fluid collections.	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.	6 months (minimum) to 5 years

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Muhammad Hasan, MD, Florida Hospital Center for Interventional ENdoscopy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimated): April 21, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Pathological Conditions, Anatomical; Pancreatic Diseases; Pancreatic Cyst; Cysts
• Other Study ID Numbers: 700323; 1108594 (Registry Identifier: Registry of Pancreatic Fluid Collections)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A manuscript will be developed following study closure.