Registry of Pancreatic Fluid Collections and Pancreatic Cysts

NCT02422095 | Withdrawn

• 2 other identifiers: 7003231108594
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Fluid Collections; Pancreatic Cyst

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Number of interventions required for treatment success in patients with pancreatic fluid collections

  6 months (minimum)

• Treatment failure in patients with pancreatic fluid collections

  6 months (minimum) to 5 years

• Adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections

  6 months (minimum) to 5 years

• Impact of disconnected pancreatic duct syndrome in patients undergoing EUS-guided drainage of pancreatic fluid collections

  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

  6 months (minimum) to 5 years

Study Arms (2)

Pancreatic fluid collections

Patients with pancreatic fluid collections undergoing endoscopy-based (EUS-guided) interventions

Procedure: Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections

Pancreatic cysts

Patients with pancreatic cysts undergoing EUS examination and possible EUS-guided sampling of cystic fluid.

Procedure: EUS of pancreatic cysts

Interventions

Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections PROCEDURE

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 fluid collections

EUS of pancreatic cysts PROCEDURE

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.

Pancreatic cysts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Florida Hospital

Orlando, Florida, 32803, United States

Location

Related Publications (2)

• 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.

  PMID: 32683101 DERIVED

• 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.

  PMID: 32066622 DERIVED

MeSH Terms

Conditions

Pancreatic Cyst

Interventions

Methods

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Muhammad Hasan, MD

  Florida Hospital Center for Interventional Endoscopy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: April 21, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)