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

Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

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

Study Overview

• Status: Unknown
• Conditions: Esophageal Neoplasms; Mediastinitis; Anastomotic Leakage
• Intervention / Treatment: Procedure: Endoscopic vacuum assisted closure

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jochen Wedemeyer, MD; Phone Number: 2406 +49 511 532; Email: wedemeyer.jochen@mh-hannover.de
• Study Contact Backup: Name: Andrea S Schneider, MD; Phone Number: 3307 +49 511 532; Email: andrea.s.schneider@gmx.de

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Recruiting
    • Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
    • Contact: Jochen Wedemeyer, MD; Phone Number: 2406 +49 511 532; Email: wedemeyer.jochen@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: E-V.A.C.; Patients that are treated with E-V.A.C.

Procedure: Endoscopic vacuum assisted closure; 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; Other Names: Endoluminal vacuum assisted closure; E-V.A.C.; Endosponnge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Closure of postsurgical leak	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Jochen Wedemeyer, MD, Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 3, 2009
• First Posted (ESTIMATE): April 6, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 26, 2010
• Last Update Submitted That Met QC Criteria: May 25, 2010
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Anastomotic leakage; Esophagectomy; Negative-Pressure Wound Therapy; Endoscopic/endoluminal V.A.C. therapy; Anastomosis, Surgical
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Mediastinal Diseases; Thoracic Diseases; Anastomotic Leak; Esophageal Neoplasms; Mediastinitis
• Other Study ID Numbers: Spongebop01