Efficacy and Safety of the Luso-Cor Esophageal Stent Compared to Other Endoscopic Techniques in the Management of Fistulas and Anastomotic Dehiscences After Upper Digestive Tract Surgery (ES-LCCE-UDFM)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Compare the efficacy of the Luso-Cor versus conventional stents versus endoscopic vacuum therapy in the management of fistulas after oncologic surgery on the stomach and esophagus and bariatric surgery in terms of fistula closure.
研究概览
简要总结
The global prevalence of obesity has prompted an increase in bariatric surgery, which is the only management strategy that provides long-term weight loss and improvement of obesity-related diseases. Bariatric surgeries include sleeve gastrectomy(SG), Roux-en-Y gastric bypass(RYGB),and laparoscopically adjustable gastric banding(LAGB). The incidence of adverse events depends on the type of bariatric surgery performed, with serious adverse events occurring in approximately 4% and mortality in 0.1% patients. The incidence of fistulas after SG varies between 0.2% to 2.5% and between 1% and 4.9% in patients who have undergone an RYGB. The incidence of strictures after SG is approximately 0.35%. Older, more obese, and male patients with multiple comorbidities related to obesity are at increased risk for the development of fistulas and mortality following bariatric surgery. Additionally, surgery after LAGB increases the risk of adverse events.
This study will compare the efficacy and safety of the Luso-Cor esophageal stent versus conventional covered metallic stents versus endoscopic vacuum therapy in the management of fistulas and anastomotic dehiscences after oncologic or bariatric surgery on the stomach and esophagus.
详细描述
The morbidity and mortality related to adverse events increases with surgical re-exploration at the site of a fistula orifice. For this reason, management of fistulas after bariatric surgery has shifted from a surgical to a primarily endoscopic approach, primarily with covered metallic stents, with fistula closure success rates between 75% and 100%. However, a primarily endoscopic approach is demanding in terms of resource use, and the high incidence of stent migration often requires multiple reinterventions - both endoscopically and surgically.
The Luso-Cor esophageal stent was designed to take into account altered anatomy after bariatric surgery and to overcome strictures in the gastric tube, which can be concomitantly present in patients with fistulas following SG. A pilot study involving 15 patients with fistulas after sleeve gastrectomy managed with the Luso-Cor esophageal stent showed a 100% rate of fistula closure, low rate of adverse events with only one episode of stent dysfunction.
A recent meta-analysis suggested that endoscopic vacuum therapy (EVT) was associated with a 21% increase in successful fistula closure compared to self expanding metallic stents (RD 0.21, CI 0.10-0.32; P = 0.0003), a 12% reduction in mortality compared to stenting (RD 0.12, CI 0.03-0.21; P = 0.006) and an average reduction of 14.22 days in duration of treatment (CI 8.38-20.07; P < 0.00001). Additionally, EVT was associated with a 24% reduction in adverse events (RD 0.24, CI 0.13-0.35; P = 0.0001. There were no statistical differences between the studied therapies regarding the length of hospital stay.
Therefore, this study aims to evaluate and compare the success of the novel Luso-Cor esophageal stent in the exclusion of fistulas, reinterventions, stent-related adverse events, duration of hospitalization and its efficacy in the management of fistulas after SG compared to other stents or EVT.
Hypothesis of the study The novel concept of esophageal anchoring of a specially designed long stent may be useful in management of fistulas after gastric surgery with high success rate and minimal morbidity compared to conventionally available esophageal or bariatric surgery stents and EVT.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing endoscopic management of fistulas after bariatric surgery or dehiscences of esophago-jejunal or gastro-jejunal anastomosis after esophageal or gastric oncologic surgery will be included in the study.
排除标准
- •Pregnancy
- •Age < 18years
- •Inability to give informed consent.
研究组 & 干预措施
Fistulas after oncologic or bariatric surgery on the stomach or esophagus
Patients who develop fistulas after oncologic surgery on the stomach or esophagus or those patients who develop fistulas after bariatric surgery (Vertical or sleeve gastrectomy or gastric bypass) managed endoscopically with endoscopic vacuum therapy group.
干预措施: Endoscopic management of fistulas with stents or vacum therapy (Procedure)
结局指标
主要结局
Compare the efficacy of the Luso-Cor versus conventional stents versus endoscopic vacuum therapy in the management of fistulas after oncologic surgery on the stomach and esophagus and bariatric surgery in terms of fistula closure.
时间窗: 36 months for recruitment of 180 patients.
To evaluate and compare the performance of the Luso-Cor oesophageal stent with other stents or EVT in management of fistulas after bariatric and oncologic surgery on the upper digestive tract with regard to fistula closure rate expressed as percentage
Compare the safety of the Luso-Cor versus conventional stents versus endoscopic vacuum therapy in the management of fistulas after oncologic surgery on the stomach and esophagus and bariatric surgery in terms of rate of adverse events
时间窗: 36 months for recruitment of 180 patients.
To evaluate and compare the safety of the Luso-Cor oesophageal stent with other stents or EVT in management of fistulas after bariatric and oncologic surgery on the upper digestive tract with regard to early and late adverse event rate expressed as percentage.
次要结局
- Compare the technical success of the Luso-Cor versus conventional stents versus endoscopic vacuum therapy in the management of fistulas after oncologic surgery on the stomach and esophagus and bariatric surgery(36 months for recruitment of 180 patients.)
- Compare duration of hospitalization in patients developing fistulas after oncologic surgery on the stomach and esophagus or bariatric surgery managed with the Luso-Cor versus conventional stents versus endoscopic vacuum therapy.(36 months for recruitment of 180 patients.)
- Compare the number of endoscopies till fistula closure in patients managed with the Luso-Cor versus conventional stents versus endoscopic vacuum therapy who developed fistulas after oncologic surgery on the stomach and esophagus or bariatric surgery.(36 months for recruitment of 180 patients.)
- Compare the mortality in patients who developed fistulas after oncologic surgery on the stomach and esophagus and bariatric surgery, managed with the Luso-Cor versus conventional stents versus endoscopic vacuum therapy.(36 months for recruitment of 180 patients.)
研究者
Carlos Noronha Ferreira
Professor Dr.
Unidade Local de Saúde Santa Maria