Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy
- Conditions
- Leaks, Anastomotic
- Registration Number
- NCT03962244
- Lead Sponsor
- University Hospital of Cologne
- Brief Summary
Exploratory study of the efficiency of endoscopic stenting versus endoscopic vacuum therapy in patients with intrathoracic esophago-gastric anastomotic leakage after oncological resection of the esophagus.
- Detailed Description
We analyze the outcome of using self-expanding metal stents (SEMS) and endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Histologically confirmed oesophageal carcinoma or similarly operated neoplasia (e.g., GIST, NET, subepithelial tumors)
- Esophagectomy with an intrathoracic esophago-gastric anastomosis
- Radiologically or endoscopically diagnosed esophago-gastric anastomotic leakage
- Clinical symptoms / symptoms due to insufficiency or increase in signs of inflammation, most likely as a result of anastomotic leakage
- Age ≥18 years
- To empower the patient to understand the scope of the study and its consequences or information, to consent to it and to sign the educational documents.
- Written declaration of consent of the patient to be included. If the patient is unable to sign by hand, a witness must confirm the oral examination by signature.
- Macroscopically incompletely resected tumor (R2), palliative resection
- Endoscopically verified necrosis or critical ischemia of the anastomotic region of the interponate
- Size of insufficiency more than 50% of circumference
- Impossibility of radiological interventional insertion of a drainage
- Early anastomotic leak (≤ 48 hours postoperatively), late insufficiencies (> 4 weeks)
- Therapeutic anticoagulation
- Severe septic shock that indicates surgical therapy
- Pregnant and lactating women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Satisfaction of treatment assessed by EORTC QLQ - OES18 6 months Assessing the quality of life of patients during the treatment of stent and EVT with a questionnaire by EORTC QLQ - OES18. This Questionnaire was developed to assess the quality of life of cancer patients.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University Hospital of Cologne
🇩🇪Cologne, NRW, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
🇩🇪Hamburg, Germany
University Hospital of Cologne🇩🇪Cologne, NRW, GermanySeungHun Chon, MDContact+49 221 478 4864seung-hun.chon@uk-koeln.deSeung-Hun Chon, MDPrincipal Investigator