Trial record 4 of 9 for:    Open Studies | "Thoracic Diseases"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00876551
First received: April 3, 2009
Last updated: May 25, 2010
Last verified: April 2009
  Purpose

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


Condition Intervention
Mediastinitis
Esophageal Neoplasms
Anastomotic Leakage
Procedure: Endoscopic vacuum assisted closure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Closure of postsurgical leak [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short term complications [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Long term complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • number of endoscopic interventions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • time to leak closure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • C reactive protein [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876551

Contacts
Contact: Jochen Wedemeyer, MD +49 511 532 ext 2406 wedemeyer.jochen@mh-hannover.de
Contact: Andrea S Schneider, MD +49 511 532 ext 3307 andrea.s.schneider@gmx.de

Locations
Germany
Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover Recruiting
Hannover, Germany, 30625
Contact: Jochen Wedemeyer, MD    +49 511 532 ext 2406    wedemeyer.jochen@mh-hannover.de   
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Jochen Wedemeyer, MD Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Jochen Wedemeyer, Department of Gastroenterology, Hepatology and Endocrinology
ClinicalTrials.gov Identifier: NCT00876551     History of Changes
Other Study ID Numbers: Spongebop01
Study First Received: April 3, 2009
Last Updated: May 25, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Negative-Pressure Wound Therapy
Endoscopic/endoluminal V.A.C. therapy
Esophagectomy
Anastomotic leakage
Anastomosis, Surgical

Additional relevant MeSH terms:
Thoracic Diseases
Neoplasms
Esophageal Neoplasms
Mediastinitis
Anastomotic Leak
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Mediastinal Diseases
Respiratory Tract Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014