Esophageal Neoplasms Clinical Trial
Official title:
Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
The purpose of this study is to determine the short and long term outcome of endoscopic vacuum assisted closure of intrathoracic postsurgical leaks.
Intrathoracic leakage is a serious complication after esophageal surgery. The reported
incidence of esophageal anastomotic leaks after gastrectomy and esophagectomy ranges from 5%
to almost 30%. Within the last 10 years endoscopic treatment has changed the approach to
intrathoracic anastomotic leakages. Application of metal clips, injection of fibrin glue and
placement of self expanding metal or plastic stents (SEMS/SEPS) have been reported to
successfully achieve closure of postoperative anastomotic leaks in approximately 66-100%.
Alternative endoscopically treatment modalities are welcome especially in cases of failure
of the above mentioned endoscopic treatment modalities to prevent the necessity of surgical
reintervention which is associated with high mortality or mutilating surgical outcome such
as proximal diversion with cervical esophagostomy.
Vacuum-assisted closure (V.A.C.) is an established treatment modality for extensive
cutaneous infected wounds. The V.A.C. system device is based on a negative pressure applied
to the wound via a vacuum sealed sponge tissue. The sponge results in formation of
granulation tissue, while the vacuum removes wound secretions and reduces edema and
therefore improves blood flow, all together achieving consecutive wound closure. Since its
introduction in the late 1990´s the number of indications for the V.A.C. system has steadily
increased. Recently the endoluminal application of a vacuum assisted wound closure system
for the closure of rectal anastomotic fistulas has been reported. Our group reported the
successful closure of intrathoracic anastomotic leaks in two cases by endoscopic placement
of a vacuum assisted closure system. Here we plan to study the efficacy, safety and long
term outcome of E-V.A.C. to treat major intrathoracic postsurgical leaks.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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