Pre-Emptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy (the preSPONGE Trial): Study Protocol for a Multicenter Randomized Controlled Trial

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.

Endoscopic vacuum therapy in the upper gastrointestinal tract: when and how to use it

“…Furthermore, it has been shown that EVT can be an effective salvage strategy to avert AL in early postoperative anastomotic ischemia and imminent leakage [ 49 ]. Considering the high incidence and the deleterious effects of AL, our group has recently demonstrated the clinical efficacy and feasibility of pEVT with PU foam drains in patients undergoing minimally invasive esophagectomy with excellent patient safety outcome parameters [ 47 , 50 ], and we have currently initiated a randomized controlled trial comparing pEVT with standard postoperative care in high-risk patients undergoing minimally invasive Ivor Lewis esophagectomy [ 51 ]. Similarly, prevention of reflux and protection of the anastomotic area from duodeno-gastric juices using double-lumen open-pored foil drains is being investigated by other groups [ 40 ].…”

Endoscopic Management for Post-Surgical Complications after Resection of Esophageal Cancer

“…PU-Sponge placement and start of the ENPT will be established intraoperatively in the intervention group. The investigators are planning to enroll a total of 100 patients (approximately 50 per group) to reach sufficient statistical power [ 89 ].…”

“…The use of fully covered metal stents in addition to CT-guided or laparoscopic placed drains or the use of ENPT can significantly reduce patients´ mortality and morbidity. The prevention of anastomotic insufficiencies after EC resection in high-risk patients using pENPT is a new, promising approach [ 88 , 89 ]. Future publications will help to define the role of preventive negative pressure therapy in the anastomosis area.…”

Adequate Management of Postoperative Complications after Esophagectomy: A Cornerstone for a Positive Outcome

“…The results did not show any side effects and were not associated with higher morbidity or mortality rates [ 103 ]. As a consequence, this working group started a randomized controlled multicenter trial (the preSponge Trial) in 2021 [ 104 ]. Halvax et al published data in which they demonstrated adequate and sufficient closure of transmural defects of up to 3 cm at a rate of 100%, using an endoluminal full-thickness suture in an animal model [ 105 ].…”