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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

Summary Self-expandable metal stents (SEMS) and endoscopic vacuum therapy (EVT) are endoscopic options for treating leaks of the esophagus. VACStent® is a variant of SEMS that aims to combine the advantages of SEMS and EVT in one device. Due to this unique construction, VACStent® can build a barrier to the leak and facilitate wound healing with EVT, all while maintaining intestinal passage. We present the first prospective feasibility study of VACStent® for treating leaks of the upper gastrointestinal tract. Between September 2019 and November 2020, we performed a prospective, investigator-initiated, single-center study and included all patients who underwent endoscopic stenting with VACStent® for various kinds of esophageal leaks, such as spontaneous, iatrogenic or anastomotic leaks. We included 20 patients, who underwent a total of 24 endoscopic VACStent® implantations. Technical success of the application of the VACStent® was achieved in all interventions (n = 24, 100%). Overall, clinical success in closing the leaks with VACStent® treatment was achieved in 60% of patients (12/20). No severe VACStent® treatment-related adverse events occurred. Oral feeding with supplement high-energy drinks failed in all patients due to clogging of the suction tube. VACStent® is a safe and feasible endoscopic treatment option for leaks of the upper gastrointestinal tract. However, our data could not show the expected advantage of orally feeding the patients during the treatment with the VACStent® in its current form. Efficacy of VACStent® compared to EVT or SEMS needs to be investigated in a further study. ClinicalTrials.gov Identifier: NCT03962179.

Introduction: Self-expanding metal stents (SEMS) are an established option for treating leaks in the upper gastrointestinal tract, and endoscopic vacuum therapy (EVT) has become a promising alternative. A novel approach is the use of an esophageal hybrid SEMS (VACStent®), which can maintain esophageal passage during EVT. We present the first study demonstrating successful use of the VACStent® for treating leaks of the upper gastrointestinal tract. Method: We performed a retrospective, single-center study of all patients who underwent endoscopic stenting with the VACStent® of leaks in the upper gastrointestinal tract. Results: Indications for treatment with the VACStent® were: iatrogenic esophageal perforation (n = 1), spontaneous perforation (n = 2), esophageal fistula (n = 2), and anastomotic leak after upper gastrointestinal surgery (n = 5). Successful application of the VACStent® was achieved in all patients (n = 10; 100%) with a total of 15 interventions. VACStent® therapy was used as a first-line treatment in 5 patient (success rate 80%; 4 out 5 patients) and as a second-line treatment after failed previous endoscopic therapy in 5 patients (success rate 60%; 3 out of 5 patients). Overall, VACStent® treatment was successful in 70% of the patients (7 out of 10). No severe VACStent® treatment-related adverse events occurred. Conclusion: The initial experience has been that the technical application of the VACStent® is safe and technically feasible. However, due to the small number of patients this study could not show the clear advantages of this novel hybrid stent. More studies are necessary to show significant advantages.

Self-expanding metal stents (SEMSs) in different geometric shapes are an established palliative treatment for malignant tumors of the esophagus. Mechanical properties and stent design have an impact on patient comfort, migration rate, and removability. SEMS with a segmented design (segSEMS) have recently become available on the market, promising new biomechanical properties for stent placement in benign and malignant esophageal diseases. In this study, we evaluated recurrent dysphagia, quality of life as well as technical success and complications for segmented SEMS-implantation in a retrospective study in palliative patients with dysphagia caused by malignant tumors of the esophagus.Between May 2017 and December 2018, patients presented to the interdisciplinary department of endoscopy of the University Hospital Cologne underwent segmented SEMS placement for malignant dysphagia. Patient follow-up was evaluated, and complications were monitored. Quality of life and functional improvement were monitored using the EORTC QLQ-C30 and QLQ-OE18.A total of 20 consecutive patients (16 men, 4 women; mean age: 65.5, range: 46-82) participated in the study and were treated with 20 segSEMS in total. The success rate of stent placement was 100%. Stent migration occurred in 3 patients (15.0%). Insertion of segSEMS immediately lead to a 48.0% reduction of dysphagia in the first 2 months (P