Leaks, Anastomotic
Conditions
Keywords
Esophagectomy, Esophageal Cancer, Vacuum therapy, Stents
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.
Interventions
DEVICEEsoSponge
Endoscopically placed an EsoSponge for Negative pressure wound therapy in the area of the esophagogastric anastomotic leaks
DEVICESelf-Expanding Metal Stent
Endoscopically placed self-expanding-metal-stent (SEMS) for negative pressure wound therapy in the area of the esophagogastric anastomotic leaks
Sponsors
Universitätsklinikum Hamburg-Eppendorf
University Hospital of Cologne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Contacts
Primary ContactSeung-Hun Chon, MD
Backup ContactChristiane Bruns, MD
Outcome results
None listed