Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
Conditions
Mediastinitis - Esophageal Neoplasms - Anastomotic Leakage
Conditions: official terms
Anastomotic Leak - Esophageal Neoplasms - Mediastinitis
Conditions: Keywords
Negative-Pressure Wound Therapy, Endoscopic/endoluminal V.A.C. therapy, Esophagectomy, Anastomotic leakage, Anastomosis, Surgical
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Endoscopic vacuum assisted closure
Type: Procedure
Overall Status
Recruiting
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 Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
Hannover, Germany
Status: Recruiting
Contact: Jochen Wedemeyer, MD - +49 511 532 - wedemeyer.jochen@mh-hannover.de
Start Date
January 2008
Completion Date
December 2012
Sponsors
Hannover Medical School
Source
Hannover Medical School
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page