NCT03544008

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endoscopic Transmural Drainage of Pancreatic Fluid Collections

Interventions

Type	Name	Description
OTHER	The use of AXIOS in Endoscopic transmural drainage

Timeline

• Start date: 2011-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-06-01
• Last updated: 2021-03-18