Clinical Trial: Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

Brief Summary: The purpose of this study is to determine the short and long term outcome of endoscopic vacuum assisted closure of intrathoracic postsurgical leaks.

Detailed Summary:

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.


Sponsor: Hannover Medical School

Current Primary Outcome: Closure of postsurgical leak [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Short term complications [ Time Frame: 6 weeks ]
  • Long term complications [ Time Frame: 6 months ]
  • number of endoscopic interventions [ Time Frame: 6 weeks ]
  • time to leak closure [ Time Frame: 6 weeks ]
  • C reactive protein [ Time Frame: 6 weeks ]


Original Secondary Outcome: Same as current

Information By: Hannover Medical School

Dates:
Date Received: April 3, 2009
Date Started: January 2008
Date Completion: December 2012
Last Updated: May 25, 2010
Last Verified: April 2009