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OpenTrials
Completed

NCT Number: NCT03544008

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age under 18

Treatment and study plan

The use of AXIOS in Endoscopic transmural drainage

Other

Primary outcomes

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

    Time frame: 24 months

Secondary outcomes

  1. 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).

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2018
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.