Registry of Pancreatic Fluid Collections and Pancreatic Cysts

NCT ID: NCT02422095

Last Updated: 2023-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Fluid Collections Pancreatic Cyst

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreatic fluid collections

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

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

Intervention Type 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 cysts

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

EUS of pancreatic cysts

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muhammad Hasan, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital Center for Interventional Endoscopy

Locations

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Florida Hospital

Orlando, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32683101 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32066622 (View on PubMed)

Other Identifiers

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1108594

Identifier Type: REGISTRY

Identifier Source: secondary_id

700323

Identifier Type: -

Identifier Source: org_study_id

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