Clinical trial NCT03962179: Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
Official title: VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perforation Esophagus
Esophageal Cancer
Esophageal Achalasia
Esophageal Diseases
Keywords: Perforation Esophagus, Esophageal Anastomotic Leak,
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication.

Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

Detailed description: The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract

Eligibility criteria: Inclusion Criteria:

* Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination
* Accessibility of the leak with the delivery system of the VAC stent

Exclusion Criteria:

* Simultaneous participation in other interventional exams
* Endoscopic inaccessibility of the affected section
* Full anticoagulation with international normalized ratio (INR) \> 1.5 and / or partial thromboplastin time (PTT) \> 50 sec, or platelets \<20.000 / μl (after therapeutic correction an inclusion is possible)
* Unstable patients with severe septic disease, who have a clinical history
* Assessment an immediate operation for safe focus switch-off requires
* Ileus image with constant vomiting (after nasogastric tube and gastric emptying an inclusion possible)
* Persons who are in a dependency / employment relationship with the sponsor or examiner stand
* Accommodation in an institution for judicial or regulatory purposes arrangement

Primary outcomes:
measure: Technique - % of patients with successful implantation of VACStent
timeFrame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Secondary outcomes:
measure: Healing of leak - % of patients with successful implantation of VACStent
timeFrame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
measure: Treatment of sepsis
timeFrame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
measure: Migration rate
timeFrame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
measure: Bleeding
timeFrame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
measure: Arrosion of tissue structures
timeFrame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
measure: Sealing of leak - % of patients with successful implantation of VACStent
timeFrame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
Study officials:
affiliation: University Hospital of Cologne
name: Seung-Hun Chon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chon SH, Bartella I, Burger M, Rieck I, Goeser T, Schroder W, Bruns CJ. VACStent: a new option for endoscopic vacuum therapy in patients with esophageal anastomotic leaks after upper gastrointestinal surgery. Endoscopy. 2020 May;52(5):E166-E167. doi: 10.1055/a-1047-0244. Epub 2019 Dec 2. No abstract available.
citation: Chon SH, Scherdel J, Rieck I, Lorenz F, Dratsch T, Kleinert R, Gebauer F, Fuchs HF, Goeser T, Bruns CJ. A new hybrid stent using endoscopic vacuum therapy in treating esophageal leaks: a prospective single-center experience of its safety and feasibility with mid-term follow-up. Dis Esophagus. 2022 Apr 19;35(4):doab067. doi: 10.1093/dote/doab067.