Hot AXIOS® Prosthesis in Real Life Conditions -

Pancreatitis,Acute Necrotizing Clinical Trial

— REALAXIOS  

Official title:

Observational Study of Patients Treated With Hot AXIOS® Prosthesis in Real Life Conditions -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782414
• Other study ID #: 19-PP-20
• Status: Completed
• Start date: April 18, 2021
• Est. completion date: November 9, 2023

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Pancreatitis,Acute Necrotizing

Intervention

Procedure:
• Hot AXIOS® prosthesis
endoscopic trans digestive drainage using of the Hot AXIOS prosthesis in the treatment of pancreatic collections (incompletely fluid or necrotic)

Locations

Country	Name	City	State
France	Avignon Hospital	Avignon
France	brest Hospital	Brest
France	Clermont-ferrand hospital	Clermont-Ferrand
France	Polyclinique Saint Côme	Compiègne
France	Lille Hospital	Lille
France	Limoges hospital	Limoges
France	Clinique Jean Mermoz	Lyon
France	APHM	Marseille
France	European Hospital	Marseille
France	St Joseph Hospital	Marseille
France	Nancy Hospital	Nancy
France	Nice Hospital	Nice
France	APHP saint antoine	Paris
France	Hôpital privé des peupliers	Paris
France	Poitiers Hospital	Poitiers
France	Saint Etienne Hospital	Saint-Étienne
France	Centre Hospitalier Jacques Lacarin	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients with clinical success	reduction in the size of the pancreatic fluid collection = 3 cm, evaluated by imaging	3 months
Secondary	Collect all complications,	Complications will be assessed according to Cotton's endoscopic classification26 (mild, moderate, severe, or fatal) [Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc.2010; 71: 446-54].	3 months
Secondary	recurrence of pancreatic collection	the presence of a collection of pancreatic origin on imaging of more than 3 cm at the 3-month check-up	3 months
Secondary	evolution of the quality of life questionnaire	Analyze the evolution of the quality of life questionnaire EQ5D5L, with as reference the one completed before the procedure	3 months
Secondary	Evaluate the technical success rate	success of the prosthesis in place at the end of the endoscopic procedure - determined by the correct trans parietal (gastric or duodenal) deployment (collar on either side of the digestive walls) and the technical success rate of the prosthesis removal (endoscopic extraction) and the date of the procedure.	3 months
Secondary	Look for factors predictive of clinical success	the predictive factors will be an aggregate of the folowing clinicals signs; sex, age, body mass index, severity score (APACHE II), aetiology of pancreatitis, size of collection, proportion of solid debris in the collection, associated pancreatic ductal rupture, glandular extension and peritoneal extension of the necrosis , location of the gastrostomy , time between admission and completion of the procedure; According to the clinical signs that motivated the intervention such as : i. Pain and/or, ii. Necrosis infection (positive culture of necrosis, presence of gas bubbles in the collection on imaging, persistent sepsis or deterioration of the patient's condition malgré´ an optimal resuscitation support without documented infection) and/or, iii. High occlusion (vomiting, food intolerance and gastric stasis on imaging) and/or, iv. Symptoms such as jaundice and/or, v. Organ failures such as kidney, heart, lung.	3 months