Clinical Trial: Endoscopic Gastroenteric Anastomosis With New Tissue Apposing Stent in the Management of Antro-pyloroduodenal Obstruction : Evaluation of Feasibility, Efficacy and Tolerance.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 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 o

Detailed Summary:
Sponsor: Assistance Publique Hopitaux De Marseille

Current Primary Outcome: Feasibility of the gastroenteric anastomosis [ Time Frame: End of procedure (up to 2 hours) ]

Technical feasibility of the anstomosis endoscopically confirmed by the ability to perform the proceudre exclusively by endoscopy, and by opacification under contrast showing the patency and the absence of fistula.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical efficacy [ Time Frame: 5 days to 6 months ]
    GOOSS score increasing by 2 points after 4 weeks of follow-up ; Weight gain > 10%
  • Long term patency [ Time Frame: 15 days after stent removal, after 6 and 12 months ]
    Ability to pass an inflated 15mm balloon and a large channel gastroscope
  • Procedure duration [ Time Frame: end of study (30 months) ]
  • Morbidity evaluation [ Time Frame: few days, 30 days, and late adverse events ]
    Cotton classification
  • Evaluation of quality of life [ Time Frame: until 12 months ]
    SF 36 Scale
  • Length of stay in hospitalization [ Time Frame: end of last hospitalization (approximatively 18 months) ]
  • Procedure learning curve [ Time Frame: end of study (30 months) ]
  • Mortality evaluation [ Time Frame: up to 30 months ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique Hopitaux De Marseille

Dates:
Date Received: September 17, 2015
Date Started: February 2016
Date Completion:
Last Updated: July 28, 2016
Last Verified: July 2016