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| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
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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.
We analyze the outcome of using self-expanding metal stents (SEMS) and endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEMS Group | The outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy |
| |
| EVT Group | The outcome of using endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EsoSponge | Device | Endoscopically placed an EsoSponge for Negative pressure wound therapy in the area of the esophagogastric anastomotic leaks |
|
| 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 |
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Inclusion Criteria:
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Patient with an intrathoracic esophago-gastric anastomotic leak after oncologic esophagectomy (Ivor-Lewis).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung-Hun Chon, MD | Contact | +49221478 4864 | seung-hun.chon@uk-koeln.de | |
| Christiane Bruns, MD | Contact | 0049221 478 4801 | Christiane.bruns@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Seung-Hun Chon, MD | University Hospital of Cologne | Principal Investigator |
| Michael Tachezy, MD | Universitätsklinikum Hamburg-Eppendorf (UKE) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Cologne | Cologne | North Rhine-Westphalia | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31049889 | Result | Bartella I, Mallmann C, Burger 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. Epub 2019 May 2. No abstract available. | |
| 30374816 | Result | Berlth F, Bludau M, Plum PS, Herbold T, Christ H, Alakus H, Kleinert R, Bruns CJ, Holscher AH, Chon SH. Self-Expanding Metal Stents Versus Endoscopic Vacuum Therapy in Anastomotic Leak Treatment After Oncologic Gastroesophageal Surgery. J Gastrointest Surg. 2019 Jan;23(1):67-75. doi: 10.1007/s11605-018-4000-x. Epub 2018 Oct 29. |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| D015607 | Stents |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Self-Expanding Metal Stent | Device | Endoscopically placed self-expanding-metal-stent (SEMS) for negative pressure wound therapy in the area of the esophagogastric anastomotic leaks |
|
|
| Universitätsklinikum Hamburg-Eppendorf (UKE) | Hamburg | Germany |
|
| 29984413 | Result | 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 management of surgical complications following esophagectomy. Ann N Y Acad Sci. 2018 Dec;1434(1):254-273. doi: 10.1111/nyas.13920. Epub 2018 Jul 8. |
| 29653446 | Result | 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. Epub 2018 Apr 13. No abstract available. |
| 29218673 | Result | Bludau M, Fuchs HF, Herbold T, Maus MKH, Alakus H, Popp F, Leers JM, Bruns CJ, Holscher AH, Schroder 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/s00464-017-5883-4. Epub 2017 Dec 7. |
| 37353654 | Derived | Mandarino FV, Barchi A, Leone L, Fanti L, Azzolini F, Viale E, Esposito D, Salmeri N, Puccetti F, Barbieri L, Cossu A, Treppiedi E, Elmore U, Rosati R, Danese S. Endoscopic vacuum therapy versus self-expandable metal stent for treatment of anastomotic leaks < 30 mm following oncologic Ivor-Lewis esophagectomy: a matched case-control study. Surg Endosc. 2023 Sep;37(9):7039-7050. doi: 10.1007/s00464-023-10213-8. Epub 2023 Jun 23. |
| 34078426 | Derived | Tachezy M, Chon SH, Rieck I, Kantowski M, Christ H, Karstens K, Gebauer F, Goeser T, Rosch T, Izbicki JR, Bruns CJ. Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial. Trials. 2021 Jun 2;22(1):377. doi: 10.1186/s13063-021-05315-4. |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D019736 |
| Prostheses and Implants |
| D004864 | Equipment and Supplies |