Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks (EVACoIL)
Primary Purpose
Mediastinitis, Esophageal Neoplasms, Anastomotic Leakage
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endoscopic vacuum assisted closure
Sponsored by
About this trial
This is an interventional treatment trial for Mediastinitis focused on measuring Negative-Pressure Wound Therapy, Endoscopic/endoluminal V.A.C. therapy, Esophagectomy, Anastomotic leakage, Anastomosis, Surgical
Eligibility 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
Sites / Locations
- Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School HannoverRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E-V.A.C.
Arm Description
Patients that are treated with E-V.A.C.
Outcomes
Primary Outcome Measures
Closure of postsurgical leak
Secondary Outcome Measures
Short term complications
Long term complications
number of endoscopic interventions
time to leak closure
C reactive protein
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00876551
Brief Title
Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
Acronym
EVACoIL
Official Title
Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hannover Medical School
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinitis, Esophageal Neoplasms, Anastomotic Leakage
Keywords
Negative-Pressure Wound Therapy, Endoscopic/endoluminal V.A.C. therapy, Esophagectomy, Anastomotic leakage, Anastomosis, Surgical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
E-V.A.C.
Arm Type
Experimental
Arm Description
Patients that are treated with E-V.A.C.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic vacuum assisted closure
Other Intervention Name(s)
Endoluminal vacuum assisted closure, E-V.A.C., Endosponnge
Intervention Description
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
Primary Outcome Measure Information:
Title
Closure of postsurgical leak
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Short term complications
Time Frame
6 weeks
Title
Long term complications
Time Frame
6 months
Title
number of endoscopic interventions
Time Frame
6 weeks
Title
time to leak closure
Time Frame
6 weeks
Title
C reactive protein
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jochen Wedemeyer, MD
Phone
+49 511 532
Ext
2406
Email
wedemeyer.jochen@mh-hannover.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea S Schneider, MD
Phone
+49 511 532
Ext
3307
Email
andrea.s.schneider@gmx.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Wedemeyer, MD
Organizational Affiliation
Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jochen Wedemeyer, MD
Phone
+49 511 532
Ext
2406
Email
wedemeyer.jochen@mh-hannover.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
18374029
Citation
Wedemeyer J, Schneider A, Manns MP, Jackobs S. Endoscopic vacuum-assisted closure of upper intestinal anastomotic leaks. Gastrointest Endosc. 2008 Apr;67(4):708-11. doi: 10.1016/j.gie.2007.10.064.
Results Reference
background
PubMed Identifier
19879566
Citation
Wedemeyer J, Brangewitz M, Kubicka S, Jackobs S, Winkler M, Neipp M, Klempnauer J, Manns MP, Schneider AS. Management of major postsurgical gastroesophageal intrathoracic leaks with an endoscopic vacuum-assisted closure system. Gastrointest Endosc. 2010 Feb;71(2):382-6. doi: 10.1016/j.gie.2009.07.011. Epub 2009 Oct 30.
Results Reference
derived
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Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
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