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Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

18 Years
Open (Enrolling)
Mediastinitis, Esophageal Neoplasms, Anastomotic Leakage

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Trial Information

Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Closure of postsurgical leak

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Jochen Wedemeyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2008

Completion Date:

December 2012

Related Keywords:

  • Mediastinitis
  • Esophageal Neoplasms
  • Anastomotic Leakage
  • Negative-Pressure Wound Therapy
  • Endoscopic/endoluminal V.A.C. therapy
  • Esophagectomy
  • Anastomotic leakage
  • Anastomosis, Surgical
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Mediastinitis
  • Anastomotic Leak