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Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks (EVACoIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876551
Recruitment Status : Unknown
Verified April 2009 by Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : April 6, 2009
Last Update Posted : May 26, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Mediastinitis Esophageal Neoplasms Anastomotic Leakage Procedure: Endoscopic vacuum assisted closure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
Study Start Date : January 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: E-V.A.C.
Patients that are treated with E-V.A.C.
Procedure: Endoscopic vacuum assisted closure
  1. Endoscopic debridement of wound using a regular biopsy forceps.
  2. Introduction via the nose and oral exteriorization of a silicone duodenal tube (Freka Tube, 15 Ch, Fresenius Kabi, Bad Homburg v.d. H. Germany)
  3. 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).
  4. Trimming of the sponge to the specific wound size.
  5. Endoscopic placement of the sponge in the intrathoracic leak with a grasping forceps (Olympus, Germany)
  6. Application of continuous suction of 125mmHg using vacuum pump (KCI, Wiesbaden Germany).
  7. Sponge exchange twice a week until wound grounds are clean and closed
Other Names:
  • Endoluminal vacuum assisted closure
  • E-V.A.C.
  • Endosponnge

Primary Outcome Measures :
  1. Closure of postsurgical leak [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Short term complications [ Time Frame: 6 weeks ]
  2. Long term complications [ Time Frame: 6 months ]
  3. number of endoscopic interventions [ Time Frame: 6 weeks ]
  4. time to leak closure [ Time Frame: 6 weeks ]
  5. C reactive protein [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876551

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Contact: Jochen Wedemeyer, MD +49 511 532 ext 2406
Contact: Andrea S Schneider, MD +49 511 532 ext 3307

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Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover Recruiting
Hannover, Germany, 30625
Contact: Jochen Wedemeyer, MD    +49 511 532 ext 2406   
Sponsors and Collaborators
Hannover Medical School
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Principal Investigator: Jochen Wedemeyer, MD Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Jochen Wedemeyer, Department of Gastroenterology, Hepatology and Endocrinology Identifier: NCT00876551    
Other Study ID Numbers: Spongebop01
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: April 2009
Keywords provided by Hannover Medical School:
Negative-Pressure Wound Therapy
Endoscopic/endoluminal V.A.C. therapy
Anastomotic leakage
Anastomosis, Surgical
Additional relevant MeSH terms:
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Esophageal Neoplasms
Anastomotic Leak
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Postoperative Complications
Pathologic Processes
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases