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Clinical Trials/NCT03544008
NCT03544008
Completed
Not Applicable

Multicenter Retrospective International Survey to Evaluate the Rate of AXIOS-related AEs in Endoscopic Transmural Drainage of Pancreatic Fluid Collections

Istituto Clinico Humanitas0 sites500 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endoscopic Transmural Drainage of Pancreatic Fluid Collections
Sponsor
Istituto Clinico Humanitas
Enrollment
500
Primary Endpoint
The investigators will evaluate the use of AXIOS in Endoscopic transmural drainage of Pancreatic fluid collections (PFC)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This is a retrospective study. Electronic chart review at respective centers will be the only database used. No patient contact or additional procedures will be conducted.

The main objectives are:

A) To evaluate the use of AXIOS in Endoscopic transmural drainage of Pancreatic fluid collections (PFC) in terms of clinical success and technical success.

B) To assess the rates, management, need for re-intervention, need for surgery, etiology and characteristics of Pancreatic fluid collections (PFC) on the occurrence of AXIOS- related related adverse events(AE).

Detailed Description

This is a retrospective study. Electronic chart review at respective centers will be the only database used. No patient contact or additional procedures will be conducted. Data that will be recorded on review of electronic medical record database include: I. Demographics (age, gender) II. Indication for procedure III. Diagnosis and findings including radiologic findings IV. Prior endoscopy treatments V. Type and number of stents used VI. Pancreatic fluid collection location and measurements VII. Procedure time VIII. Technical success IX. Clinical success X. Adverse events XI. Management of adverse events XII. Recurrence of pancreatic fluid collections XIII. Follow-up time The above data will be collected and recorded in an excel sheet. The data collection will be completely de-identified and password protected. The file will be emailed using an institution email and encrypted. The password will be given in a separate email or by phone call. Inclusion: All patients undergoing endoscopic management of pancreatic fluid collections between January 2011 to June 2017 Exclusion: Age under 18 We will enroll 100 record between January 2011 to June 2017. Time for collecting data: 1 month for data collection and 3 weeks for data analysis.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All patients undergoing endoscopic management of pancreatic fluid collections between January 2011 to June 2017

Exclusion Criteria

  • Age under 18

Outcomes

Primary Outcomes

The investigators will evaluate the use of AXIOS in Endoscopic transmural drainage of Pancreatic fluid collections (PFC)

Time Frame: 24 months

Secondary Outcomes

  • The investigators will assess the rates, management, need for re-intervention, need for surgery, etiology and characteristics of Pancreatic fluid collections (PFC) on the occurrence of AXIOS- related related adverse events(AE).(24 months)

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