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

Endoscopic Transmural Drainage of Pancreatic Fluid Collections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544008
• Other study ID #: Axios AEs
• Status: Completed
• Start date: January 2011
• Est. completion date: December 2020

Study information

• Verified date: March 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age under 18

Related Conditions & MeSH terms

• Endoscopic Transmural Drainage of Pancreatic Fluid Collections

Intervention

Other:
• The use of AXIOS in Endoscopic transmural drainage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The investigators will evaluate the use of AXIOS in Endoscopic transmural drainage of Pancreatic fluid collections (PFC)		24 months
Secondary	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