Project description:IntroductionEndoscopic vacuum therapy (EVT) has gained a greater role in management of transmural defects in the upper gastrointestinal (GI) tract, including anastomotic leakage and esophageal perforation (e.g. Boerhaave syndrome and iatrogenic causes). The vacuum-stent is a new treatment modality, combining the benefits of EVT and an intraluminal stent.Patients and methodsThis prospective case series describes the first ten cases of a transmural defect in the upper GI tract treated with a vacuum-stent in a tertiary referral center. All patients signed informed consent for prospective registration of relevant data on treatment and outcomes in a specially designed database. Outcome parameters were successful closure of the defect, number of endoscopies, duration of treatment and adverse events.ResultsIn total, ten patients treated with a vacuum-stent were included. Eight patients had anastomotic leakage after esophageal resection, of whom six were treated with vacuum-sponge and vacuum-stent, and two with vacuum-stent only. One patient had Boerhaave syndrome, treated with vacuum-sponge and vacuum-stent, and one had an iatrogenic perforation during pneumodilation for achalasia, treated with vacuum-stent only. Success rate was 100%, requiring a median of 5 (IQR 3-12) EVT-related endoscopies with a treatment course of median 18 (IQR 12-59) days. One patient developed an esophageal stricture, but no other vacuum-stent related adverse events were observed.ConclusionThe vacuum-stent, which combines benefits of EVT and an intraluminal stent, shows great feasibility and efficacy in treatment of transmural defects in the upper GI tract. Future studies should point out whether this device can prevent major (re-)surgery in these patients.
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:Endoscopic Vacuum Therapy (EVT) has been reported as a novel treatment option for esophageal leakage. We present our results in the treatment of iatrogenic perforation with EVT in a case series of 10 patients.An open pore polyurethane drainage was placed either intracavitary through the perforation defect or intraluminal covering the defect zone. Application of vacuum suction with an electronic device (continuous negative pressure, -125 mmHg) resulted in defect closure and internal drainage.Esophageal perforations were located from the cricopharyngeus (4/10) to the esophagogastric junction (2/10). EVT was feasible in all patients. Eight patients were treated with intraluminal EVT, one with intracavitary EVT, and one with both types of treatments. All perforations (100 %) were healed in within a median of (3 - 7) days. No stenosis occurred, no complications were observed, and no additional operative treatment was necessary.Our study suggests that intraluminal EVT will play an important role in endoscopic management of esophageal perforation.
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.
Project description:IntroductionGastric leaks constitute some of the most severe complications after obesity surgery. Resulting peritonitis can lead to inflammatory changes of the stomach wall and might necessitate drainage. The inflammatory changes make gastric leak treatment difficult. A common endoscopic approach of using stents causes the problem of inadequate leak sealing and the need for an external drainage. Based on promising results using endoscopic vacuum therapy (EVT) for esophageal leaks, we implemented this concept for gastric leak treatment after bariatric surgery (Ahrens et al., Endoscopy 42(9):693-698, 2010; Schniewind et al., Surg Endosc 27(10):3883-3890, 2013).MethodsWe retrospectively analyzed data of 31 gastric leaks after bariatric surgery. For leak therapy management, we used revisional laparoscopy with suturing and drainage. EVT was added for persistent leaks in sixteen cases and was used in four cases as standalone therapy.ResultsTwenty-one gastric leaks occurred in 521 sleeve gastrectomies (leakage rate 4.0%), 9 in 441 Roux-en-Y gastric bypasses (leakage rate 2.3%), and 1 in 12 mini-bypasses. Eleven of these gastric leaks were detected within 2 days after bariatric surgery and successfully treated by revision surgery. Sixteen gastric leaks, re-operated later than 2 days, remained after revision surgery, and EVT was added. Without revision surgery, we performed EVT as standalone therapy in 4 patients with late gastric leaks. The EVT healing rate was 90% (18 of 20). In 2 patients with a late gastric leak in sleeve gastrectomy, neither revisional surgery, EVT, nor stent therapy was successful. EVT patients showed no complications related to EVT during follow-up.ConclusionEVT is highly beneficial in cases of gastric leaks in obesity surgery where local peritonitis is present. Revisional surgery was unsuccessful later than 2 days after primary surgery (16 of 16 cases). EVT shows a similar healing rate to stent therapy (80-100%) but a shorter duration of treatment. The advantages of EVT are endoscopic access, internal drainage, rapid granulation, and direct therapy control. In compartmentalized gastric leaks, EVT was successful as a standalone therapy without external drainage.
Project description:Esophageal perforation is associated with a significant risk of morbidity and mortality. We report herein a case of lye-induced esophageal perforation managed successfully by employing endoscopic T-tube placement with a successful outcome.
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.