Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

Not Applicable

• Conditions: Mediastinitis; Esophageal Neoplasms; Anastomotic Leakage
• Interventions: Procedure: Endoscopic vacuum assisted closure

• Registration Number: NCT00876551
• Lead Sponsor: Hannover Medical School

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 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.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-26
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E-V.A.C.	Endoscopic vacuum assisted closure	Patients that are treated with E-V.A.C.

Primary Outcome Measures

Name	Time	Method
Closure of postsurgical leak	6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover; 🇩🇪 Hannover, Germany