BACKGROUND: Obesity is the pandemic disease of this century. Surgery is the only effective treatment but cannot be offered to every patient. Endoscopic sutured gastroplasty is a minimally invasive technique that may potentially fill the gap between surgery and behavioral therapy. In this study, we prospectively investigated the efficacy and safety of a novel suturing device. METHODS: After a pre-bariatric multidisciplinary work-up, class 1 and 2 obese patients were included. Using a simple triangulation platform, transmural sutures with serosa-to-serosa apposition were performed in the gastric cavity. Patients were followed according to the same routines as those performed for bariatric procedures. RESULTS: Between November 2015 and December 2016, 51 patients were included across three European Centers. Mean body mass index at baseline was 35.1 kg/m2 (SD 3.0). Excess weight loss and total body weight loss at 1 year were 29 % (SD 28) and 7.4 % (SD 7), respectively, for the whole cohort (45 patients). At follow-up gastroscopy, 88 % of sutures were still in place (30 patients). No severe adverse events were observed. CONCLUSIONS: Endoscopic sutured gastroplasty using this novel device is safe and achieved weight loss results in line with criteria expected for these endoluminal techniques. Further prospective studies vs. placebo or nutritional support are needed.
- MeSH
- dospělí MeSH
- gastroplastika škodlivé účinky přístrojové vybavení MeSH
- gastroskopie MeSH
- hmotnostní úbytek MeSH
- index tělesné hmotnosti MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- obezita chirurgie MeSH
- prospektivní studie MeSH
- šicí techniky škodlivé účinky přístrojové vybavení MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- audiovizuální média MeSH
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
BACKGROUND: Malignant gastric outlet obstruction is often treated by stent placement. OBJECTIVE: To investigate the outcomes of stent placement in the palliative treatment of malignant neoplasms. DESIGN: Prospective, observational, multicenter registry. SETTING: Six tertiary care centers in 5 countries. PATIENTS: A total of 108 adult patients with malignant gastric outlet obstruction. INTERVENTIONS: Placement of an uncovered, self-expandable, metal duodenal stent. MAIN OUTCOME MEASUREMENTS: The primary endpoint was stent patency at 14 days after stent implantation. Secondary endpoints included stent patency at 1, 2, 3, and 6 months, gastric outlet obstruction scoring system (GOOSS) scores at 14 days and 1, 2, 3, and 6 months after stent deployment, technical success, adverse events, and patient survival (ie, confirmed duration of the implant). RESULTS: Technical success was achieved in 99.1% of stent placements. Stent patency at 14 days was 94.6%. Kaplan-Meier estimates of stent patency were 92.9% at 1 month, 86.2% at 2 months, 81.9% at 3 months, and 63.4% at 6 months. At 14 days, GOOSS scores increased by a median of 1 point. The overall GI adverse event rate was 32.4%; however, the stent-related adverse event rate was 19.4%. The median implant duration was 47 days (range 0-195 days). LIMITATIONS: Observational study, no control group. CONCLUSIONS: Duodenal stent placement resulted in prompt relief of malignant gastric outlet obstruction and improved GOOSS scores. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00991614.).
- MeSH
- časové faktory MeSH
- dospělí MeSH
- gastrointestinální endoskopie škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory trávicího systému komplikace MeSH
- obstrukce vyprazdňování žaludku etiologie terapie MeSH
- paliativní péče * MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- stenty * škodlivé účinky MeSH
- stupeň závažnosti nemoci MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
26 stran : ilustrace ; 21 cm
42 stran : ilustrace ; 21 cm
- MeSH
- bronchiální nemoci diagnóza MeSH
- dolní gastrointestinální trakt patologie ultrastruktura MeSH
- gastrointestinální nemoci diagnóza MeSH
- horní gastrointestinální trakt patologie ultrastruktura MeSH
- sliznice patologie ultrastruktura MeSH
- úzkopásmové zobrazení metody využití MeSH
- Publikační typ
- atlasy MeSH
