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

NCT ID: NCT03544008

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Endoscopic Transmural Drainage of Pancreatic Fluid Collections

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

The use of AXIOS in Endoscopic transmural drainage

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Age under 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Fugazza A, Sethi A, Trindade AJ, Troncone E, Devlin J, Khashab MA, Vleggaar FP, Bogte A, Tarantino I, Deprez PH, Fabbri C, Aparicio JR, Fockens P, Voermans RP, Uwe W, Vanbiervliet G, Charachon A, Packey CD, Benias PC, El-Sherif Y, Paiji C, Ligresti D, Binda C, Martinez B, Correale L, Adler DG, Repici A, Anderloni A. International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage. Gastrointest Endosc. 2020 Mar;91(3):574-583. doi: 10.1016/j.gie.2019.11.021. Epub 2019 Nov 20.

Reference Type: DERIVED

PMID: 31759037 (View on PubMed)

Other Identifiers

Axios AEs

Identifier Type: -

Identifier Source: org_study_id