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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00876551
Other study ID # Spongebop01
Secondary ID
Status Recruiting
Phase N/A
First received April 3, 2009
Last updated May 25, 2010
Start date January 2008
Est. completion date December 2012

Study information

Verified date April 2009
Source Hannover Medical School
Contact Jochen Wedemeyer, MD
Phone +49 511 532
Email wedemeyer.jochen@mh-hannover.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Germany Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover Hannover

Sponsors (1)

Lead Sponsor Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Closure of postsurgical leak 6 weeks No
Secondary Short term complications 6 weeks Yes
Secondary Long term complications 6 months Yes
Secondary number of endoscopic interventions 6 weeks No
Secondary time to leak closure 6 weeks No
Secondary C reactive protein 6 weeks Yes
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