Abstract
Introduction:Anastomotic leakage (AL) accounts for a significant proportion of morbidity following oesophagectomy. Endoluminal negative pressure (ENP) therapy via a specifically designed polyurethane foam (EsoSponge®, B.Braun Medical, Melsungen, Germany) has become the standard of care for AL in many specialized centres. The prophylactic (pENP) application of this technique aims to reduce postoperative morbidity and is a novel approach which has not yet been investigated in a prospective study. The aim of this study is therefore to assess the effect of pENP at the anastomotic site in high-risk patients undergoing minimally invasive transthoracic Ivor Lewis oesophagectomy.Methods and analysis:The study design is a prospective, multi-centre, two-arm, parallel-group, randomised controlled trial and will be conducted in two phases. Phase one is a randomised feasibility and safety pilot trial involving 40 consecutive patients. After definitive sample size calculation, additional patients will be included accordingly during phase two. The primary outcome of the study will be the postoperative length of hospitalization until reaching previously defined “fit for discharge criteria”. Secondary outcomes will include postoperative morbidity, mortality and postoperative AL-rates based on 90-day follow-up. A confirmatory analysis based on intention-to-treat will be performed.Ethics and dissemination:The ethics committee of the University of Zurich approved this study (2019-00562), which has been registered with ClinicalTrials.gov on 14.11.2019 (NCT04162860) and the Swiss National Clinical Trials Portal (SNCTP000003524). The results of the study will be published and presented at appropriate conferences.
Highlights
Anastomotic leakage (AL) accounts for a significant proportion of morbidity following oesophagectomy
Protocol modifications will be reported to all investigators, the local ethics committee, the Clinical Trials Register, all trial participants, and the journal. This prospective multi-centre, parallel-group Randomised controlled trial serious adverse events (SAE) (RCT) aims to assess the effect of prophylactic ENP (pENP) on AL after ttMILE in high-risk patients
Endoscopic placement of the polyurethane foam at the level of the anastomosis with Endoluminal negative pressure (ENP) has been exclusively used for the treatment of AL, whilst published data regarding its prophylactic application remains scarce [11,12,13, 24, 25]
Summary
Anastomotic leakage (AL) accounts for a significant proportion of morbidity following oesophagectomy. The aim of this study is to assess the effect of pENP at the anastomotic site in high-risk patients undergoing minimally invasive transthoracic Ivor Lewis oesophagectomy. A recent hypothesis is that the pathophysiology of this entity involves a triad of local ischaemia, bacterial infection, and inflammation [4,5,6] Predisposing factors such as arteriosclerosis, diabetes, and lung disease have been associated as risk factors for the development of AL in patients undergoing oesophagectomy [7,8,9,10]. Endoscopic placement of a specially designed polyurethane foam at the level of the anastomosis with subsequent endoluminal negative pressure (ENP) therapy has a high success rate in treating AL [11,12,13]. No adverse events attributable to pENP therapy were observed in this series [15]
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