Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

NCT ID: NCT00876551

Last Updated: 2010-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Mediastinitis; Esophageal Neoplasms; Anastomotic Leakage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

E-V.A.C.

Patients that are treated with E-V.A.C.

Group Type: EXPERIMENTAL

Endoscopic vacuum assisted closure

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Endoluminal vacuum assisted closure; E-V.A.C.; Endosponnge

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Department of Gastroenterology, Hepatology and Endocrinology

Principal Investigators

Jochen Wedemeyer, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover

Locations

Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover

Hanover, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Jochen Wedemeyer, MD

Role: CONTACT

wedemeyer.jochen@mh-hannover.de

+49 511 532 ext. 2406

Andrea S Schneider, MD

Role: CONTACT

andrea.s.schneider@gmx.de

+49 511 532 ext. 3307

Facility Contacts

Jochen Wedemeyer, MD

Role: primary

wedemeyer.jochen@mh-hannover.de

+49 511 532 ext. 2406

References

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.

Reference Type: BACKGROUND

PMID: 18374029 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19879566 (View on PubMed)

Other Identifiers

Spongebop01

Identifier Type: -

Identifier Source: org_study_id