Project description:Injuries to the esophageal wall, such as perforations and anastomotic leaks, are serious complications of surgical and endoscopic interventions. Since 2006, a new treatment has been introduced, in the form of endoscopically placed vacuum sponge therapy.Between April 2012 and October 2014, 10 patients (5 men and 5 women) aged 57 to 94 years were treated at our institution using endoscopic vacuum therapy (EVT) in the upper gastrointestinal tract.The defect in the esophageal wall was successfully closed in seven of the 10 patients (70 %). No severe complications occurred.EVT is a valuable tool for management of defects in the esophageal wall and should be considered as a treatment option for patients with this condition.
Project description:Esophageal wall defects, including perforations and postoperative leaks, are associated with high morbidity and mortality and pose a significant management challenge. In light of the high morbidity of surgical management or revision, in recent years, endoscopic vacuum therapy (EVT) has emerged as a novel alternative treatment strategy. EVT involves transoral endoscopic placement of a polyurethane sponge connected to an externalized nasogastric tube to provide continuous negative pressure with the intention of promoting defect healing, facilitating cavity drainage, and ameliorating sepsis. In the last decade, EVT has become increasingly adopted in the management of a diverse spectrum of esophageal defects. Its popularity has been attributed in part to the growing body of evidence suggesting superior outcomes and defect closure rates in excess of 80%. This growing body of evidence, coupled with the ongoing evolution of the technology and techniques of deployment, suggests that the utilization of EVT has become increasingly widespread. Here, we aimed to review the current status of the field, addressing the mechanism of action, indications, technique methodology, efficacy, safety, and practical considerations of EVT implementation. We also sought to highlight future directions for the use of EVT in esophageal wall defects.
Project description:Background and study aims Esophageal defects (leaks, fistulas, and perforations) are associated with significant morbidity and mortality. Endoluminal vacuum-assisted closure (EVAC) is a novel intervention that entails the use of sponges in the defect along with negative pressure to achieve granulation tissue formation and healing and has been gaining popularity. We performed a systematic review and pooled analysis of available literature to assess the safety and effectiveness of EVAC for esophageal defects. Patients and methods We queried PubMed/Medline, Embase, Cochrane, and Web of Science through September 25, 2020 to include all pertinent articles highlighting the safety and effectiveness profile of EVAC for esophageal defects. Pooled rates, 95 % confidence intervals (CIs), and heterogeneity ( I 2 ) were assessed for each outcome. Results A total of 18 studies with 423 patients were included (mean age 64.3 years and males 74.4 %). The technical success for EVAC was 97.1 % (CI: 95.4 %-98.7 %, I 2 = 0 %). The clinical success was 89.4 % (CI: 85.6 %-93.1 %, I 2 = 36.8 %). The overall all-cause mortality and adverse events (AEs) noted were 7.1 % (CI: 4.7 %-9.5 %, I 2 = 0 %) and 13.6 % (CI: 8.0 %-19.1 %, I 2 = 68.9 %), respectively. The pooled need for adjuvant therapy was 15.7 % (CI: 9.8 %-21.6 %, I 2 = 71.1 %). Conclusions This systematic review and meta-analysis showed high rates of technical success, clinical success, and low all-cause mortality and AEs using EVAC. Although the technique is a promising alternative, the lack of comparative studies poses a challenge in making definite conclusions regarding use of EVAC compared to other endoscopic modalities, such as clips and stents.
Project description:BackgroundEndoluminal vacuum-assisted therapy (EVT) has been introduced recently to treat colorectal anastomotic leakage. The aim of this study was to evaluate the safety and efficacy of EVT in the treatment of anastomotic leakage and rectal stump insufficiency after Hartmann's procedure.MethodsA systematic search of MEDLINE, Scopus and Cochrane databases was performed using search terms related to EVT and anastomotic leakage or rectal stump insufficiency in line with the PRISMA checklist. Observational studies, RCTs and case series studies published to July 2017 were included. Primary outcomes of the review were the success of EVT, defined as complete or partial healing of the anastomotic defect and associated cavity, and the rate of stoma reversal after EVT. Secondary outcomes included the duration of treatment to complete healing, complications of treatment and the need for further intervention. A meta-analysis was conducted. The potential effect of clinical confounders on the failure of EVT was investigated using the random-effects meta-regression model.ResultsOf 476 articles identified, 17 studies reporting on 276 patients were ultimately included. The weighted mean rate of success was 85·3 (95 per cent c.i. 80·1 to 90·5) per cent, with a median duration from inception of EVT to complete healing of 47 (range 40-105) days. The weighted mean rate of stoma reversal across the studies was 75·9 (64·6 to 87·2) per cent. Twenty-five patients (9·1 per cent) required additional interventions after EVT. Thirty-eight patients (13·8 per cent) developed complications. The weighted mean complication rate across the studies was 11·1 (6·0 to 16·2) per cent. Variables significantly associated with failure included preoperative radiotherapy, absence of diverting stoma, complications and male sex.ConclusionEVT is associated with a high rate of complete healing of anastomotic leakage and stoma reversal. It is an effective option in appropriately selected patients with anastomotic leakage.
Project description:Esophageal anastomotic leak is the most common and serious complication following esophagectomy. However, the standard treatment for anastomotic leaks remains unclear. Recently, endoscopic vacuum therapy has become an important non-surgical alternative treatment method for patients with esophageal anastomotic leak. This treatment involves the endoscopic placement of a sponge connected to a nasogastric tube into the defect cavity or lumen. Subsequently, continuous negative pressure is delivered to the cavity through the tube. Several studies have reported a treatment success rate of 80% to 100%. In this study, we review the mechanism of action, the method of performing the procedure, its safety and efficacy, and prognostic factors for failure of endoscopic vacuum therapy in the management of patients with anastomotic leak, and on this basis attempted to confirm the possibility of establishing a standardized treatment protocol using endoscopic vacuum therapy.
Project description:Background and Aims:GI perforations, leaks, and fistulas are types of full-thickness mural defects that frequently occur as adverse events from GI surgeries such as esophagectomy for malignancy and bariatric surgery. Historically, treatment has entailed a combination of reoperation, percutaneous drainage, and bowel rest. Recently, there has been a changing paradigm in the management of these defects. Endoscopic interventions, including endoclipping and placement of self-expanding metal stents (SEMSs), have been increasingly used with good success. Despite this, some defects remain refractory to these techniques. Endoscopic vacuum-assisted closure (EVAC) is a new, promising endoscopic approach to repairing these defects. EVAC works through applying continuous, controlled negative pressure at the defect with the use of an endoscopically placed polyurethane sponge connected to an electronic vacuum device. EVAC has been shown to be feasible, safe, and effective. Methods:We present a video series of 3 cases demonstrating the successful application of EVAC for the treatment of anastomotic leakage after esophagectomy and of fistula formation after bariatric surgery. Results:Two patients experienced anastomotic leakage after esophagectomy for esophageal adenocarcinoma, and 1 patient experienced a chronic gastric fistula after Roux-en-Y gastric bypass. The gastric bypass patient's fistula failed to resolve with over-the-scope-clip placement, and all 3 patients' defects did not heal despite SEMS placement; therefore, EVAC was performed. The bariatric surgery patient required 9 sponge exchanges over 35 days, and the 2 esophagectomy patients each required 3 sponge exchanges over 13 days. All 3 patients had resolution of their defects with EVAC. No adverse events occurred, and all patients have had no recurrence for several months. Conclusions:These cases help to highlight the feasibility, safety, and efficacy of EVAC for the closure of full-thickness GI defects. On the basis of our experience, the use of EVAC should be considered for these complex and refractory cases.
Project description:BackgroundIntrathoracic 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov NCT03962244 . Registered on May 23, 2019. DRKS-ID DRKS00007941.