Clinical trial NCT00876551: Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
Official title: Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mediastinitis
Esophageal Neoplasms
Anastomotic Leakage
Keywords: Negative-Pressure Wound Therapy
Endoscopic/endoluminal V.A.C. therapy
Esophagectomy
Anastomotic leakage
Anastomosis, Surgical
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Closure of postsurgical leak
timeFrame: 6 weeks
Secondary outcomes:
measure: Short term complications
timeFrame: 6 weeks
measure: Long term complications
timeFrame: 6 months
measure: number of endoscopic interventions
timeFrame: 6 weeks
measure: time to leak closure
timeFrame: 6 weeks
measure: C reactive protein
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
Study officials:
affiliation: Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
name: Jochen Wedemeyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.