Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy

Study Overview
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Brief Summary
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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
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We analyze the outcome of using self-expanding metal stents (SEMS) and endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy.

Official Title
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Endoscopic Management of ESOphago-gastric Anastomotic LEAKages (EsoLeak): Stent Therapy Versus Endoscopic Vacuum Therapy

Conditions
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Leaks, Anastomotic

Intervention / Treatment
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* Device: EsoSponge
* Device: Self-Expanding Metal Stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SEMS Group<br>The outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy | Device: Self-Expanding Metal Stent<br>* Endoscopically placed self-expanding-metal-stent (SEMS) for negative pressure wound therapy in the area of the esophagogastric anastomotic leaks<br>* Other names: SEMS, stent;|
| EVT Group<br>The outcome of using endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy | Device: EsoSponge<br>* Endoscopically placed an EsoSponge for Negative pressure wound therapy in the area of the esophagogastric anastomotic leaks<br>* Other names: Negative pressure wound therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of treatment assessed by EORTC QLQ - OES18 | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagectomy, Esophageal Cancer, Vacuum therapy, Stents