Leaks, Anastomotic Clinical Trial
— EsoLeakOfficial title:
Endoscopic Management of ESOphago-gastric Anastomotic LEAKages (EsoLeak): Stent Therapy Versus Endoscopic Vacuum Therapy
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.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | December 31, 2023 |
| Est. primary completion date | April 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital of Cologne | Cologne | NRW |
| Germany | Universitätsklinikum Hamburg-Eppendorf (UKE) | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of Cologne | Universitätsklinikum Hamburg-Eppendorf |
Germany,
Bartella I, Mallmann C, Bürger M, Toex U, Goeser T, Bruns C, Chon SH. Stent-over-sponge (SOS): a rescue option in patients with complex postoperative anastomotic leaks after esophagectomy. Endoscopy. 2019 Aug;51(8):E227-E228. doi: 10.1055/a-0885-9659. Epu — View Citation
Berlth F, Bludau M, Plum PS, Herbold T, Christ H, Alakus H, Kleinert R, Bruns CJ, Hölscher AH, Chon SH. Self-Expanding Metal Stents Versus Endoscopic Vacuum Therapy in Anastomotic Leak Treatment After Oncologic Gastroesophageal Surgery. J Gastrointest Sur — View Citation
Bludau M, Fuchs HF, Herbold T, Maus MKH, Alakus H, Popp F, Leers JM, Bruns CJ, Hölscher AH, Schröder W, Chon SH. Results of endoscopic vacuum-assisted closure device for treatment of upper GI leaks. Surg Endosc. 2018 Apr;32(4):1906-1914. doi: 10.1007/s004 — View Citation
Chon SH, Toex U, Plum PS, Fuchs C, Kleinert R, Bruns C, Goeser T. Successful closure of a gastropulmonary fistula after esophagectomy using the Apollo Overstitch and endoscopic vacuum therapy. Endoscopy. 2018 Jul;50(7):E149-E150. doi: 10.1055/a-0592-6384. — View Citation
Grimminger PP, Goense L, Gockel I, Bergeat D, Bertheuil N, Chandramohan SM, Chen KN, Chon SH, Denis C, Goh KL, Gronnier C, Liu JF, Meunier B, Nafteux P, Pirchi ED, Schiesser M, Thieme R, Wu A, Wu PC, Buttar N, Chang AC. Diagnosis, assessment, and manageme — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |