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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Satisfaction of treatment assessed by EORTC QLQ - OES18