Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

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

Detailed Description
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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.

Official Title
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Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

Conditions
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Mediastinitis, Esophageal Neoplasms, Anastomotic Leakage

Intervention / Treatment
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* Procedure: Endoscopic vacuum assisted closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients at the Medical School Hannover that present with intrathoracic postsurgical leakage that can be intubated with a regular 9.2mm diameter endoscope (Olympus GIF-165, Olympus Age over 18 years old Signed informed consent Exclusion Criteria: Small leakage that can be treated with clips Refusal to participate in study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-V.A.C.<br>Patients that are treated with E-V.A.C. | Procedure: Endoscopic vacuum assisted closure<br>* Endoscopic debridement of wound using a regular biopsy forceps. Introduction via the nose and oral exteriorization of a silicone duodenal tube (Freka Tube, 15 Ch, Fresenius Kabi, Bad Homburg v.d. H. Germany) Fixation of a polyurethane foam (sponge, pore size 400-600 µm, KCI, Wiesbaden Germany) to the tip of the duodenal tube with a mersilene suture (0,35mm, Johnson & Johnson, St-Stevens-Woluwe, Belgium). Trimming of the sponge to the specific wound size. Endoscopic placement of the sponge in the intrathoracic leak with a grasping forceps (Olympus, Germany) Application of continuous suction of 125mmHg using vacuum pump (KCI, Wiesbaden Germany). Sponge exchange twice a week until wound grounds are clean and closed<br>* Other names: Endosponnge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of postsurgical leak |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term complications |  | 6 weeks | 
| Long term complications |  | 6 months | 
| number of endoscopic interventions |  | 6 weeks | 
| time to leak closure |  | 6 weeks | 
| C reactive protein |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Negative-Pressure Wound Therapy, Endoscopic/endoluminal V.A.C. therapy, Esophagectomy, Anastomotic leakage, Anastomosis, Surgical