MediastinitisEVACoILNCT00876551
Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
A study testing Endoscopic vacuum assisted closure in people with Mediastinitis and Esophageal Neoplasms, run by Hannover Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinitis, Esophageal Neoplasms, Anastomotic Leakage
- What is being tested?
- Endoscopic vacuum assisted closure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Small leakage that can be treated with clips
- Refusal to participate in study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
Hanover, 30625
Jochen Wedemeyer, MD, +49 511 532 ext. 2406, wedemeyer.jochen@mh-hannover.de
About this study
Official title: 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.
Read the 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
- Being tested
- Endoscopic vacuum assisted closure
- Keywords
- Negative-Pressure Wound Therapy, Endoscopic/endoluminal V.A.C. therapy, Esophagectomy, Anastomotic leakage, Anastomosis, Surgical
- Medical subject headings
- Mediastinitis, Esophageal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic vacuum assisted closureProcedure or surgery
Also called Endoluminal vacuum assisted closure, E-V.A.C., Endosponnge
- 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
| Study group | Role | What they receive |
|---|---|---|
| E-V.A.C. | Experimental | Patients that are treated with E-V.A.C. Receives: Procedure: Endoscopic vacuum assisted closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of postsurgical leak
Measured: 6 weeks
Secondary outcomes (5)
Short term complications
Measured: 6 weeks
Long term complications
Measured: 6 months
number of endoscopic interventions
Measured: 6 weeks
time to leak closure
Measured: 6 weeks
C reactive protein
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MediastinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Jochen Wedemeyer, MD, Principal investigator, Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876551
- Sponsor's protocol ID
- Spongebop01
- Acronym
- EVACoIL
- Status last verified
- Apr 2009
- First submitted
- 3 Apr 2009
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18374029Wedemeyer 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.
PubMed 19879566
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
- ClinicalTrials.gov ID
- NCT00876551
- Acronym / sponsor ID
- EVACoIL / Spongebop01
- Conditions
- Mediastinitis, Esophageal Neoplasms, Anastomotic Leakage
- Keywords
- Negative-Pressure Wound Therapy, Endoscopic/endoluminal V.A.C. therapy, Esophagectomy, Anastomotic leakage, Anastomosis, Surgical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 6 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-V.A.C. | Experimental | Procedure: Endoscopic vacuum assisted closurePatients that are treated with E-V.A.C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Small leakage that can be treated with clips
- Refusal to participate in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic vacuum assisted closureAlso: Endoluminal vacuum assisted closure, E-V.A.C., Endosponnge1. 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 | Procedure or surgery | E-V.A.C. |
Primary outcome
Closure of postsurgical leak
Time frame: 6 weeks
5 secondary outcomes
Short term complications
Time frame: 6 weeks
Long term complications
Time frame: 6 months
number of endoscopic interventions
Time frame: 6 weeks
time to leak closure
Time frame: 6 weeks
C reactive protein
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
- Background: PubMed 18374029Wedemeyer 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.
- Derived from this study: PubMed 19879566Wedemeyer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Wedemeyer, MD principal investigator
Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic vacuum assisted closure in people with Mediastinitis and Esophageal Neoplasms, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jochen Wedemeyer, MD (+49 511 532 ext. 2406, wedemeyer.jochen@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure of postsurgical leak (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876551, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2010.