Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy (NCT03962244) | Clinical Trial Compass
UnknownNot Applicable
Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy
Germany40 participantsStarted 2021-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Satisfaction of treatment assessed by EORTC QLQ - OES18