Clinical trial NCT02562157: Endoscopic Gastroenteric Anastomosis With New Tissue Apposing Stent in the Management of Antro-pyloroduodenal Obstruction : Evaluation of Feasibility, Efficacy and Tolerance.
Official title: Gastroenteric Anastomosis With Natural Orifice Translumenal Endoscopic Surgery (NOTES) Using the New Fashionned Tissue Apposing Stent Axios® for the Treatment of Antro-pyloric or Duodenal Obstructions : Prospective Evaluation of Feasibility, Efficacy and Tolerance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antro-pyloric and/or Duodenal Benign or Malignant Obstructions
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Achieving gastro-jejunal or duodenal anastomosis (GJA ) by exclusive endoscopically is a real goal for many years in the development and research of the transluminal endoscopic surgery (N.O.T.E.S). Endoscopic treatment, including palliative antro duodenal stenosis by metallic stent, although minimally invasive, causes problems in long-term secondary obstruction and migration. Surgical treatment of these strictures is associated with significant morbidity and mortality . The complication rate and severity of post-operative surgery after gastric bypass Roux-en-Y anastomosis or gastroduodenal fistulas remain close to 5% with a mortality of 1%. After 3 years of experimental research on porcine model, our team has developed a procedure of gastro duodenal anastomosis using transgastric endoscopic minimally invasive surgical technique (or NOTES) - LBA UMRT24 CERC laboratory , Aix-Marseille University , Faculty of Medicine North, with the aim to offer a credible alternative to conventional surgery.

Thus the investigators propose to conduct a pilot prospective intervenionnal study. The investigators hypothetized that this technique would reduce morbidity and mortality clinical but also economic consequences of surgery while making it possible to obtain excellent results permeability and long-term functionality. This method uses a new concept of tissue apposition with a fully covered metallic stent to create the anastomosis under endoscopy exclusively. Ten patients with antro duodenal obstructions requiring surgical or endoscopic bypass will be included as part of an interventional biomedical research that will be conducted in one expert center. The duration of the inclusions will be 18 months. Then, the stent will be removed three months after insertion, at the end of the healing process, and each patient will be followed for one year. The primary endpoint will be the assessment of the feasibility of the procedure for gastro duodenal anastomosis using tissue apposition stenting and NOTES in human being. The secondary endpoints will be the clinical efficacy, the long term (1 year) patency of the anastomosis, the procedure duration, adverse events, morbidity and mortality, the quality of life and the length of stay.

In case of failure of the NOTES procedure, the patient will be treated either by surgery or by conventional endoscopy according to the usual techniques without loss of chance. The risk / benefit ratio appears positive and a safety report will be issued after the first 4 inclusions. There will be no supplementary examination in patient follow-up in this study for which a CT iconography and biology are enough. The material used in the context of this work is consistent with the legislation on medical devices and has received CE Mark (tissue apposition fully covered stent Axios ®).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Benign or malignant antropyloric or duodenal obstruction leaving free the 3rd and the 4th duodenum, confirmed by CT scan or endoscopy
* Patient having been hospitalized at least once for this indication, with failure of medical treatment and/or failure or impossibility of endoscopic treatment using metallic duodenal stenting.
* Patients having under nutrition with a weight loss \> 10%
* Theorical indication of surgical gastroenteric anastomosis with operating contraindication or refusal of the surgery by the patient
* Indication validated during multidisciplinary meeting
* GOOSS score = 0 or 1
* Patient having received clear and complete information and given written consent
* Patient having medical care insurrance

Exclusion Criteria:

* Contraindication to general anesthesia
* Severe hemostasis and coagulation troubles : Prothrombin level \< 50% and/or platelets level \< 50G/l
* History of duodenal or gastric surgery
* Pregnancy or population of vulnerable patients
* Mental deficiency
* Voluntary withdrawal of informed consent
* Discontinuation by decision of the investigator or the promotor

Primary outcomes:
measure: Feasibility of the gastroenteric anastomosis
timeFrame: End of procedure (up to 2 hours)
Secondary outcomes:
measure: Clinical efficacy
timeFrame: 5 days to 6 months
measure: Long term patency
timeFrame: 15 days after stent removal, after 6 and 12 months
measure: Procedure duration
timeFrame: end of study (30 months)
measure: Morbidity evaluation
timeFrame: few days, 30 days, and late adverse events
measure: Evaluation of quality of life
timeFrame: until 12 months
measure: Length of stay in hospitalization
timeFrame: end of last hospitalization (approximatively 18 months)
measure: Procedure learning curve
timeFrame: end of study (30 months)
measure: Mortality evaluation
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Urielle DESALBRES, Director
role: STUDY_DIRECTOR
References: