Clinical trial NCT04059926: National Registry of Lumen Apossing Metal Stent Incidences
Official title: National Registry of Lumen Apossing Metal Stent Incidences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interventional Ultrasonography
Lead sponsor: Hospital del Rio Hortega
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have a transmural PAL are placed prospectively and consecutively

Brief summary: Study design: Prospective Case Series Disease or disorder under study: Lifespan of the Axios apposition luminal prosthesis Population under study: Patients with an Axios type intraluminal apposition prosthesis

Expected dates of completion:

* Start: January 2019
* Completion: December 2020 Funding source: Does not require financing

Detailed description: Hypothesis:

The presence of events or incidents in the follow-up and the subsequent removal of the Axios type luminal apposition prosthesis is not related to the patent time and the indication

Design:

Prospective Case Series

Methods:

- Patients: All patients who have a transmural PAL in all participating centers will be included prospectively and consecutively.

-Tracing: Patients who meet the inclusion criteria and do not present any exclusion criteria will be invited to participate in the study. The patients who agree to participate will complete the informed consent (see annex II) according to the law 41/2002 of patient autonomy without thereby altering the relationship with their doctor or causing any damage in their treatment. It will have a maximum duration of 1 year or until the first scheduled follow-up after the removal of the prosthesis. It will consist of pre-established clinical controls and radiological controls performed according to the underlying disease.

* Clinical control It will be done in person or by phone. They will be carried out after 14 days, 3, 6, 9 and 12 months from the placement of the prosthesis. Visits of 14 days, 3, 6 and 9 months may be made by telephone as an option (in case of request by the patient, limited mobility ...).
* Radiological control Radiological controls will not be performed in an established manner by participating in the study. However, abdominal imaging tests performed for any other reason will be used to confirm the presence of the stent in situ, checking these tests at the last follow-up visit.
* End of follow-up time:

A follow-up will be carried out until the first scheduled visit after the withdrawal of the PAL ( if removed at 8 weeks, it would be the 3-month visit), in patients in whom it is placed with a permanent intention, until completing 1 year of follow-up and in patients in whom technical success is not obtained until the first follow-up view (14 days). The data will be recorded in an electronic data collection notebook (CRD) in which the variables indicated in the data collection sheet will be included.

- Sample size: The number of prostheses used annually in our center ranges from 70-100. In other third level centers approximately 15-50 prostheses can be placed annually. In other centers the number of annual prostheses may be markedly lower, below the 10 annual prostheses. Depending on the number of participating centers, we consider that the number of patients included can range between 250-350.

Data management. The CRD data will be entered by the principal investigator or the collaborating researchers anonymously, encrypted and dissociated from the clinical information through a patient identification code (ID), in an online database through the RedCap platform. The responsible physician, in turn, a researcher, will define an ID for each patient, whose relationship with the medical history will only be accessible by him, with his custody in a file protected by personal password. The data entered in the database will be anonymous and the database will be password protected to which only researchers will have access.

The unified file will be kept in the Río Hortega University Hospital and will remain until the end of the study. The CRDs collected in the file will be kept in the Digestive Service to ensure their accessibility to the researchers and their control.

With regard to the application of the Organic Law on Data Protection 15/1999 and the Royal Decree 1720/2007 that develops it, it should be noted that the protocol defined in the project aimed at epidemiological analysis, determines that the files will record information completely anonymized A file will be maintained with the information collected for the development of the project within the framework defined in the Maximum Level Security Document of the Río Hortega University Hospital whose responsibility is the Management of said organization.

This document is of obligatory knowledge and available in the Intranet of the University Hospital Río Hortega. The levels of security, access and availability will be those defined in that document.

Statistical analysis. Categorical variables will be described as percentages. Continuous with normal distribution as mean and standard deviation. Continuous variables with non-normal distributions will be described as medians and interquartile range (the range can also be offered). Pearson's χ2 test or Fisher's exact test (in case the expected frequencies in the contingency tables are below 5) will be applied to assess differences between categorical variables. When analyzing possible risk factors of the objective variables (e.g., presence or absence of complications, presence or absence of embedded prostheses ...) logistic regression techniques will be used. The analysis will be carried out using Stata (StataCorp. 2013. College Station, Texas).

Ethical aspects. - Benefit-risk assessment for research subjects This study involves conducting a prospective observational study. The procedure to which patients undergo will be performed regardless of participation in the study. The only consequence of participating is that the data concerning the procedure will be collected during the procedure and that the patient will be contacted to verify the absence of deferred complications and complete the follow-up. Therefore, participation will not imply any benefit or prejudice to the participant. The benefit we hope to obtain is to identify if there are endoscopic factors that predict possible complications in the prostheses described above. This study will be carried out following the standards specified in the Declaration of Helsinki, the Standards of Good Clinical Practice, the guidelines ICH (International Conference on Harmonization) and complying with current legislation, in particular Law 14/2007 on Biomedical Research.

In cases where the placement of the prosthesis is done on a scheduled basis, prior consent will be obtained. In cases where it is performed urgently / emergently or in the face of exploration findings, consent will be requested after the exploration is completed. The principal investigator and the collaborators will be authorized to make use of the data collected in the CRD, as well as to contact the patient to complete the follow-up. In any case, the rights, security and welfare of the subjects of the study must prevail over the interests of science and society.

The patient will be identified in the study database by an identification code (ID), sex and date of birth. The databases and other documents of the study will be available to the Health Authorities if they consider it relevant, in no case will they be available to third parties.

This study will not require an insurance policy for civil liability, which covers any damages or losses derived from it.

-Data confidentiality The study data will initially be dissociated from the medical history, by means of an ID, by the responsible physician. The relationship between the ID and the medical record will be guarded by the medical researchers in a file protected with a personal password. The data will be entered in the database anonymously with the patient's ID, to maintain their anonymity. The database will be password protected, and only accessible by researchers. During the study, strict compliance with Law 15/1999, of December 13 on the Protection of Personal Data, is guaranteed.

Eligibility criteria: Inclusion Criteria:

* Patients in whom at least the initial puncture of the access organ wall is achieved for the transmural placement of an Axios type PAL

Exclusion Criteria:

* Refusal to sign the informed consent.
* Inability to track

Primary outcomes:
measure: Describe the type and proportion of complications that arise from the Axios apposition luminal prosthesis, through study completion, an average of 1 year
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
Study officials:
References:
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