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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Notify MeKey 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
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).
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.