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1000 Titel
  • Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial
1000 Autor/in
  1. Tachezy, Michael |
  2. Chon, Seung-Hun |
  3. Rieck, Isabel |
  4. Kantowski, Marcus |
  5. Christ, Hildegard |
  6. Karstens, Karl |
  7. Gebauer, Florian |
  8. Goeser, Tobias |
  9. Rösch, Thomas |
  10. Izbicki, Jakob R. |
  11. Bruns, Christiane J. |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-06-02
1000 Erschienen in
1000 Quellenangabe
  • 22(1):377
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s13063-021-05315-4 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8170795/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Background!#!Intrathoracic anastomotic leaks represent a major complication after Ivor Lewis esophagectomy. There are two promising endoscopic treatment strategies in the case of leaks: the placement of self-expanding metal stents (SEMS) or endoscopic vacuum therapy (EVT). Up to date, there is no prospective data concerning the optimal endoscopic treatment strategy. This is a protocol description for the ESOLEAK trial, which is a first small phase 2 randomized trial evaluating the quality of life after treatment of anastomotic leaks by either SEMS placement or EVT.!##!Methods!#!This phase 2 randomized trial will be conducted at two German tertiary medical centers and include a total of 40 patients within 2 years. Adult patients with histologically confirmed esophageal cancer, who have undergone Ivor Lewis esophagectomy and show an esophagogastric anastomotic leak on endoscopy or present with typical clinical signs linked to an anastomotic leak, will be included in our study taking into consideration the exclusion criteria. After endoscopic verification of the anastomotic leak, patients will be randomized in a 1:1 ratio into two treatment groups. The intervention group will receive EVT whereas the control group will be treated with SEMS. The primary endpoint of this study is the subjective quality of life assessed by the patient using a systematic and validated questionnaire (EORTC QLQ C30, EORTC QLQ-OES18 questionnaire). Important secondary endpoints are healing rate, period of hospitalization, treatment-related complications, and overall mortality.!##!Discussion!#!The latest meta-analysis comparing implantation of SEMS with EVT in the treatment of esophageal anastomotic leaks suggested a higher success rate for EVT. The ESOLEAK trial is the first study comparing both treatments in a prospective manner. The aim of the trial is to find suitable endpoints for the treatment of anastomotic leaks as well as to enable an adequate sample size calculation and evaluate the feasibility of future interventional trials. Due to the exploratory design of this pilot study, the sample size is too small to answer the question, whether EVT or SEMS implantation represents the superior treatment strategy.!##!Trial registration!#!ClinicalTrials.gov NCT03962244 . Registered on May 23, 2019. DRKS-ID DRKS00007941.
1000 Sacherschließung
lokal Interventional endoscopy
lokal Stents [MeSH]
lokal Esophagectomy
lokal Self-expanding metal stents
lokal Endoscopic vacuum therapy
lokal Anastomotic Leak/diagnosis [MeSH]
lokal Randomized Controlled Trials as Topic [MeSH]
lokal Esophageal Neoplasms/surgery [MeSH]
lokal Quality of Life [MeSH]
lokal Negative-Pressure Wound Therapy [MeSH]
lokal Clinical Trials, Phase II as Topic [MeSH]
lokal Meta-Analysis as Topic [MeSH]
lokal Anastomotic Leak/therapy [MeSH]
lokal Adult [MeSH]
lokal Study Protocol
lokal Humans [MeSH]
lokal Prospective Studies [MeSH]
lokal Treatment Outcome [MeSH]
lokal Retrospective Studies [MeSH]
lokal Endoscopy [MeSH]
lokal Anastomotic leaks
lokal Anastomotic Leak/etiology [MeSH]
lokal Esophagectomy/adverse effects [MeSH]
lokal Esophageal cancer
lokal Pilot Projects [MeSH]
1000 Liste der Beteiligten
  1. https://frl.publisso.de/adhoc/uri/VGFjaGV6eSwgTWljaGFlbA==|https://orcid.org/0000-0002-8923-6428|https://frl.publisso.de/adhoc/uri/UmllY2ssIElzYWJlbA==|https://frl.publisso.de/adhoc/uri/S2FudG93c2tpLCBNYXJjdXM=|https://frl.publisso.de/adhoc/uri/Q2hyaXN0LCBIaWxkZWdhcmQ=|https://frl.publisso.de/adhoc/uri/S2Fyc3RlbnMsIEthcmw=|https://frl.publisso.de/adhoc/uri/R2ViYXVlciwgRmxvcmlhbg==|https://frl.publisso.de/adhoc/uri/R29lc2VyLCBUb2JpYXM=|https://frl.publisso.de/adhoc/uri/UsO2c2NoLCBUaG9tYXM=|https://frl.publisso.de/adhoc/uri/SXpiaWNraSwgSmFrb2IgUi4=|https://frl.publisso.de/adhoc/uri/QnJ1bnMsIENocmlzdGlhbmUgSi4=
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