Luso-Cor Stent Compared to Other Endoscopic Techniques for Management of Fistulas and Anastomotic Dehiscences(ES-LCCE-UDFM)

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic management of fistulas with stents or vacum therapy: A prospective registry of patients who develop fistulas after oncologic surgery on the stomach or esophagus as well as those after bariatric surgery and managed endoscopically with stents or endoscopic vacuum therapy will be evaluated to assess and compare the efficacy and safety of the Luso-Cor versus conventional partially or fully covered metallic stents or bariatric stents or endoscopic vacuum therapy.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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. — 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 — 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.

Trial sites (1)

Other trials for the same condition