Clinical trial NCT04782414: Hot AXIOS® Prosthesis in Real Life Conditions -
Official title: Observational Study of Patients Treated With Hot AXIOS® Prosthesis in Real Life Conditions -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis,Acute Necrotizing
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having benefited from the treatment of pancreatic collections

Brief summary: Regulatory Context The CNEDiMTS makes the renewal of registration conditional on the transmission of the results of a well-conducted prospective study, carried out with Hot AXIOS, the objective of which is to evaluate the interest of this device in real conditions of use with regard to effectiveness and complications after a minimum follow-up of 3 months.

Operators are trained in the use of the equipment (practice on ex-vivo model and/or prior stent placement) and undertake to comply with the rules and formalities of use.

Primary efficacy objective :

To evaluate the efficacy of endoscopic trans digestive drainage after use of the Hot AXIOS prosthesis in the treatment of pancreatic collections (incompletely fluid or necrotic) at 3 months.

Secondary Objectives :

Assessment of the following elements :

1. Morbidity (complication rates) and mortality per- and post-procedure
2. Recurrence rate of pancreatic collection
3. Evolution of the quality of life questionnaire (SQ5D5L)
4. Technical success rate of prosthesis placement and removal success rate of the prosthesis
5. Search for factors predictive of clinical success of endoscopic pancreatic drainage with the Hot Axios prosthesis.

Study design Non-interventional/observational (RIPH 3 type), multi-center, prospective study with consecutive inclusions evaluating the Hot AXIOS® prosthetic device.

Non-inclusion registry A minimum amount of information will be collected anonymously, including sex, age, indication of drainage and reason for non-inclusion (e.g. refusal of the patient, of the investigator for impossibility of following the patient in the centre or other reasons to be specified). Generic information will be affixed in each centre participating in the study indicating: "In application of the provisions of the Data Protection Act, general information on the possibility that personal data may be used for research purposes must be provided in any establishment or centre where prevention, diagnosis and care activities are carried out". This must be exhaustive and rigorously maintained.

Equipment used in endoscopy Hot AXIOS™ - self-expanding metal prosthesis with a lumen diameter of 6 to 20 mm and collar length of 8 and 10 mm or any future similar device marketed under the same name at the time of the study.

Technique Insertion of the material under echo-endoscopic control -- possible but not systematic dilatation -- guide wire with hydrophilic tip - Puncture and release under echo-endoscopic control according to the centre's usual practice.

Registration The data will be collected anonymously in an electronic computer database using eCRFs.

Statistical analysis The evaluation of the clinical success of endoscopic pancreatic necrosectomy with metallic prosthesis will first consist in describing its efficacy according to the criteria described above.

Analysis plan :

The statistical analysis will first include a description of the study population with the number of patients falling under the indication and treated with the Hot AXIOS system at the recruiting centers (source population), the number of eligible patients who consented to participate in the study, the number of patients included (study population), the number of subjects who made each visit and were analyzed, premature exits (deaths, lost to follow-up) will be reported and described in the form of a flow chart.


Eligibility criteria: Inclusion Criteria:

* Should benefit from the installation of a Hot Axios system as part of PBDA support, regardless of the indication.
* Age ≥ 18 years old,
* Having signed his or her no objection or the trusted person if the patient is unable to do so prior to the procedure
* Affiliated to a social security scheme

Exclusion Criteria:

• Patients who have indicated that they do not wish to participate in the study.

Primary outcomes:
measure: patients with clinical success
timeFrame: 3 months
Secondary outcomes:
measure: Collect all complications,
timeFrame: 3 months
measure: recurrence of pancreatic collection
timeFrame: 3 months
measure: evolution of the quality of life questionnaire
timeFrame: 3 months
measure: Evaluate the technical success rate
timeFrame: 3 months
measure: Look for factors predictive of clinical success
timeFrame: 3 months
Other outcomes:
Locations:
city: Avignon
country: France
facility: Avignon Hospital
city: Brest
country: France
facility: brest Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-ferrand hospital
city: Compiègne
country: France
facility: Polyclinique Saint Côme
city: Lille
country: France
facility: Lille Hospital
city: Limoges
country: France
facility: Limoges hospital
city: Lyon
country: France
facility: Clinique Jean Mermoz
city: Marseille
country: France
facility: APHM
city: Marseille
country: France
facility: European Hospital
city: Marseille
country: France
facility: St Joseph Hospital
city: Nancy
country: France
facility: Nancy Hospital
city: Nice
country: France
facility: Nice Hospital
city: Paris
country: France
facility: APHP saint antoine
city: Paris
country: France
facility: Hôpital privé des peupliers
city: Poitiers
country: France
facility: Poitiers Hospital
city: Saint-Étienne
country: France
facility: Saint Etienne Hospital
city: Vichy
country: France
facility: Centre Hospitalier Jacques Lacarin
Study officials:
References: