Antro-pyloric and/or Duodenal Benign or Malignant Obstructions Clinical Trial
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.
| Verified date | July 2023 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 ®).
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | July 13, 2023 |
| Est. primary completion date | January 6, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Feasibility of the gastroenteric anastomosis | 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. | End of procedure (up to 2 hours) | |
| Secondary | Clinical efficacy | GOOSS score increasing by 2 points after 4 weeks of follow-up ; Weight gain > 10% | 5 days to 6 months | |
| Secondary | Long term patency | Ability to pass an inflated 15mm balloon and a large channel gastroscope | 15 days after stent removal, after 6 and 12 months | |
| Secondary | Procedure duration | end of study (30 months) | ||
| Secondary | Morbidity evaluation | Cotton classification | few days, 30 days, and late adverse events | |
| Secondary | Evaluation of quality of life | SF 36 Scale | until 12 months | |
| Secondary | Length of stay in hospitalization | end of last hospitalization (approximatively 18 months) | ||
| Secondary | Procedure learning curve | end of study (30 months) | ||
| Secondary | Mortality evaluation | up to 30 months |