Endoscopic treatment in anastomotic leakage after upper gastrointestinal surgery: endoscopic self-expandable metallic stent or endoluminal vacuum therapy?

BackgroundMetabolic bariatric surgery (MBS) is standardized and safe. Nevertheless, complications such as anastomotic leakage (AL) or staple-line leakage (SLL) can occur. In upper GI or colorectal surgery, endoluminal vacuum therapy (EVT) offers a therapeutic alternative to revisional surgery. Data on EVT in patients with leakage after MBS remain scarce. The aim of this study is to evaluate the efficacy of EVT and its potential as endoscopic alternative to revisional surgery.Material and MethodsAll patients treated for AL or SLL with EVT after MBS between 01/2016 and 08/2023 at the Department for General Surgery, Medical University Vienna, were included in this retrospective, single-center study. Therapeutic value of EVT as management option for acute postoperative leakage after MBS in daily practice was evaluated. Statistical analyses were performed descriptively.ResultsTwenty-one patients were treated with EVT within the observational period of 7 years. In 11 cases (52.4%), the index surgery was a primary bariatric intervention; in 10 cases (47.6%), a secondary surgery after initial MBS was performed. Favored approach was a combination of revisional surgery and EVT (n = 18; 85.7%), intermediate self-expanding metal stent (SEMS) in 16 (76.2%) cases. EVT was changed six times (0–33) every 3–4 days. Mean EVT time was 25.1 days (3–97). No severe associated complications were detected and EVT showed an efficacy of 95.2%.ConclusionThis small case series supports the trend to establish EVT in daily clinical practice when revisional surgery after MBS is needed, thus preventing further reoperation and reducing associated morbidity and mortality in critically ill patients.Graphical

Introduction: Management of esophageal anastomotic leaks (AL) and esophageal perforations (EP) remains difficult and often requires an interdisciplinary treatment modality. For primary endoscopic management, self-expanding metallic stent (SEMS) placement is often considered first-line therapy. Recently, endoscopic vacuum therapy (EVT) has emerged as an alternative or adjunct for management of these conditions. So far, data for EVT in the upper gastrointestinal-tract is restricted to single centre, non-randomized trials. No studies on optimal negative pressure application during EVT exist. The aim of our study is to describe our centre’s experience with low negative pressure (LNP) EVT for these indications over the past 5-years. Patients and Methods: Between January 2014 and December 2018, 30 patients were endoscopically treated for AL (n = 23) or EP (n = 7). All patients were primarily treated with EVT and LNP between –20 and –50 mm Hg. Additional endoscopic treatment was added when EVT failed. Procedural and peri-procedural data, as well as clinical outcomes including morbidity and mortality, were analysed. Results: Clinical successful endoscopic treatment of EP and AL was achieved in 83.3% (n = 25/30), with 73.3% success using EVT alone (n = 22/30). Mean treatment duration until leak closure was 16.1 days (range 2–58 days). Additional treatment modalities for complete leak resolution was necessary in 10% (n = 3/30), including SEMS placement and fibrin glue injection. Mean hospital stay for patients with EP was shorter with 33.7 days compared to AL with 54.4 days (p = 0.08). Estimated preoperative 10-year overall survival (Charlson comorbidity score) was 39.4% in patients with AL and 59.9% in patients with EP (p = 0.26). A mean of 5.1 EVT changes (range 1–12) was needed in EP and 3.6 changes (range 1–13) in AL to achieve complete closure, switch to other treatment modality, or reach endoscopic failure (p = 0.38). Conclusion: LNP EVT enables effective minimally – invasive endoluminal leak closure from anastomotic esophageal leaks and EP in high-morbid patients. In this study, EVT was combined with other endoscopic treatment options such as SEMS placement or fibrin glue injection in order to achieve leak or perforation closure in the vast majority of patients (83.3%). Low aspiration pressures led to slower but still sufficient clinical results.

Anastomotic leaks and staple line disruptions are among the most serious complications following upper gastrointestinal (GI) surgery, contributing significantly to postoperative morbidity and mortality. This case series describes the clinical application, outcomes, and technical aspects of EVT in patients with postoperative leaks after partial pharyngectomy, gastrectomy, and esophageal diverticulectomy. We retrospectively reviewed three consecutive patients treated with EVT for postoperative leaks between January 2023 and March 2025 at Intermed Hospital. EVT was performed using a polyurethane sponge attached to a nasogastric or nasoesophageal tube, applying continuous negative pressure (−115-125 mmHg) via an external suction device. The patients (2 males, 1 female; mean age 53.4 years) developed leaks after various upper GI procedures, including esophageal diverticulectomy, partial pharyngectomy, and remnant total gastrectomy. EVT duration ranged from 10 to 28 days, with 3 to 8 sponge changes per patient. EVT is an effective and safe treatment for anastomotic leaks after upper GI surgery. It promotes healing, reduces the need for surgical reintervention, and can be successfully applied across a range of postoperative leak scenarios. Early diagnosis, proper sponge positioning, and multidisciplinary care are key to achieving optimal outcomes.

Background: Anastomotic leakage (AL) is a major complication after esophago-gastric surgery, with incidence rates of 11-21% and mortality up to 14%. Early intervention is essential to reduce morbidity. Endoscopic treatments have advanced, with self-expandable metal stents (SEMSs) as the traditional standard (success ~90%), but they carry risks like migration, stenosis, and need for drainage. Endoscopic vacuum therapy (EVT), applying negative pressure to drain secretions and promote healing, has shown success rates of 66-100%. Limited comparative data exists from small retrospective studies. This study compares SEMS and EVT for safety and efficacy in AL management. Methods: A retrospective case-control study from a prospective database at our institution was performed (March 2012-2025). We included patients with AL post-esophageal/gastric surgery treated endoscopically (SEMS or EVT). We excluded patients treated with conservative or surgical management. Demographics, comorbidities, oncology, surgery type, leak details, treatments, and outcomes were collected. Primary outcome was complete healing of the leak, while secondary outcomes were time to success, number of procedures needed, hospital stay, complications, mortality. Results: From 592 resections, we extracted 68 AL (11.5%), 45 of which met the inclusion criteria (22 SEMS, 23 EVT). Groups were similar demographically, but SEMS had more respiratory issues (43% vs. 8.7%, p = 0.018). SEMS were used more after esophagectomy (86.4% vs. 56.5%, p = 0.004); EVT was performed mostly after gastrectomy (34.7% vs. 9.1%, p = 0.009). Success rate was 86.4% for SEMS vs. 95.6% for EVT (p = 1.000). Complications were significantly lower in EVT (8.3% vs. 50%, p = 0.001; SEMS: 36.4% migrations, 18.2% stenoses). Leak onset time, modality of diagnosis, and leak size were comparable among the groups. Need for jejunostomy was higher in EVT (43.5% vs. 9.1%, p = 0.015), while chest drains in SEMS (63.7% vs. 13.1%, p < 0.001). Hospital stays (33-38 days, p = 0.864) and mortality (22.7% vs. 8.7%, p = 0.225) were similar. No differences were observed in terms of long-term mortality (log-rank p = 0.815). Conclusions: SEMS and EVT are both effective for AL after esophago-gastric surgery. EVT offers fewer complications and shorter treatment, so it is favored especially for esophago-jejunal leaks.

Recently, endoscopic vacuum therapy (EVT) was introduced as treatment for anastomotic leakage after upper gastrointestinal (GI) surgery. The aim of this study was to describe the initial experience with EVT for anastomotic leakage after upper GI surgery in a tertiary referral center. Patients treated with EVT for anastomotic leakage after upper GI surgery were included retrospectively (January 2018-June 2021) and prospectively (June 2021-October 2021). The primary end point was the EVT success rate. Secondary end points included mortality and adverse events. 38 patients were included (31 men; mean age 66 years): 27 had undergone an esophagectomy with gastric conduit reconstruction and 11 a total gastrectomy with esophagojejunal anastomosis. EVT was successful in 28 patients (74 %, 95 %CI 57 %-87 %). In 10 patients, EVT failed: deceased owing to radiation pneumonitis (n = 1), EVT-associated complications (n = 2), and defect closure not achieved (n = 7). Mean duration of successful EVT was 33 days, with a median of six EVT-related endoscopies. Median hospital stay was 45 days. This initial experience with EVT for anastomotic leakage after upper GI surgery demonstrated a success rate of 74 %. EVT is a promising therapy that could prevent further major surgery. More experience with the technique and its indications will likely improve success rates in the future.

Most anastomotic leaks in the upper gastrointestinal (GI) tract can be treated with minimally invasive techniques dominated by endoluminal vacuum therapy (EVT) or stent implantation. Chronic leaks often require additional solutions, such as tissue adhesives or cellular growth stimulants. To present a treatment strategy for postoperative leakage of upper GI anastomoses with noninvasive procedures. A group of 19 patients treated in the period 2015-2023 with postoperative upper GI tract leakage was enrolled for endoscopic treatment. The indication for the therapy was anastomotic dehiscence not exceeding half of the circumference and the absence of severe septic complications. All patients were managed using endoscopic vacuum therapy (EVT) or a self-expanding stent while persistent fistulas were additionally treated with alternative methods. The EVT was successfully implemented in 13 cases, but 7 patients required alternative methods to achieve definitive healing. Self-expanding stent placement was performed in 6 patients; however, in 3 cases a periprosthetic leakage occurred. In this group, 2 patients had the stent removed and the third one died due to septic complications. Post-treatment stenosis was identified in 5 patients after EVT that required balloon dilation with acceptable resolution in all cases. Early detected anastomotic dehiscence limited to half of the circumference most effectively responded to the noninvasive treatment. Nutritional support as well as complementary endoscopic solutions such as tissue adhesives, growth stimulants and hemostatic clips increase the percentage of complete healing.

Anastomotic leakage (AL) is one of the most serious complications of upper gastro-intestinal (UGI) surgery. Recently endoscopic vacuum therapy (EVT), using an endoscopically placed sponge, was introduced as treatment of AL. The aim of this study was to describe the initial experiences with EVT in a tertiary referral center, in the treatment of AL after esophago-gastric surgery. For this retrospective cohort study, all patients treated with EVT for AL in the UGI tract at a tertiary referral center, between January 2018 and October 2021, were included. In this period, patients with AL, based on CT-scan or endoscopic findings, were primarily treated with EVT. Cases were identified from the endoscopy reporting system, with a search including all available terms for EVT, and from the prospective UGI surgery database. Data on patient characteristics, EVT and outcomes were analyzed. The primary endpoint was success rate of EVT alone, defined as closure of the defect assessed by endoscopy or CT-scan. A total of 38 patients were included (Table 1). Successful treatment with EVT was achieved in 28 patients (74%, 95%CI[57,87]). In 10 patients EVT failed: one deceased during treatment (due to radiation pneumonitis) and 9 underwent additional surgery: two due to an EVT-related complication (a trachea-esophageal fistula and iatrogenic expansion of the defect during overtube placement) and 7 because defect closure was not achieved. EVT-associated complications occurred in two patients, as described above. Median hospital stay was 42 days. Median duration of EVT was 27 days, with median 6 EVT-related endoscopies and 5 days between sponge-exchanges. EVT is a paradigm shifting treatment, potentially preventing surgical re-intervention in patients with AL after UGI surgery, with a success rate of 74%. More experience with the technique and indications for use will likely improve success rates in the future.

Endoscopic treatment of post-esophagectomy/gastrectomy anastomotic dehiscence includes Self-Expandable Metal Stents (SEMS), which have represented the "gold standard" for many years, and Endoscopic Vacuum Therapy (EVT), which was recently introduced, showing promising results. The aim of the study was to compare outcomes of SEMS and EVT in the treatment of post-esophagectomy/gastrectomy anastomotic leaks, focusing on oncologic surgery. A systematic search was performed on Pubmed and Embase, identifying studies comparing EVT versus SEMS for the treatment of leaks after upper gastro-intestinal surgery for malignant or benign pathologies. The primary outcome was the rate of successful leak closure. A meta-analysis was conducted, performing an a priori-defined subgroup analysis for the oncologic surgery group. Eight retrospective studies with 357 patients were eligible. Overall, the EVT group showed a higher success rate (odd ratio [OR] 2.58, 95% CI 1.43-4.66), a lower number of devices (pooled mean difference [pmd] 4.90, 95% CI 3.08-6.71), shorter treatment duration (pmd -9.18, 95% CI -17.05--1.32), lower short-term complication (OR 0.35, 95% CI 0.18-0.71) and mortality rates (OR 0.47, 95% CI 0.24-0.92) compared to stenting. In the oncologic surgery subgroup analysis, no differences in the success rate were found (OR 1.59, 95% CI 0.74-3.40, I2 = 0%). Overall, EVT has been revealed to be more effective and less burdened by complications compared to stenting. In the oncologic surgery subgroup analysis, efficacy rates were similar between the two groups. Further prospective data need to define a unique management algorithm for anastomotic leaks.

Modified endoscopic vacuum therapy: Are we ready for prime time?

BackgroundComplications after surgery for esophageal cancer are associated with significant resource utilization. The aim of this study was to analyze the economic burden of two frequently used endoscopic treatments for anastomotic leak management after esophageal surgery: Treatment with a Self-expanding Metal Stent (SEMS) and Endoscopic Vacuum Therapy (EVT).Materials and methodsBetween January 2012 and December 2016, we identified 60 German-Diagnosis Related Group (G-DRG) cases of patients who received a SEMS and / or EVT for esophageal anastomotic leaks. Direct costs per case were analyzed according to the Institute for Remuneration System in Hospitals (InEK) cost-accounting approach by comparing DRG payments on the case level, including all extra fees per DRG catalogue.ResultsIn total, 60 DRG cases were identified. Of these, 15 patients were excluded because they received a combination of SEMS and EVT. Another 6 cases could not be included due to incomplete DRG data. Finally, N = 39 DRG cases were analyzed from a profit-center perspective. A further analysis of the most frequent DRG code -G03- including InEK cost accounting, revealed almost twice the deficit for the EVT group (N = 13 cases, € - 9.282 per average case) compared to that for the SEMS group (N = 9 cases, € - 5.156 per average case).ConclusionEndoscopic treatments with SEMS and EVT for anastomotic leaks following oncological Ivor Lewis esophagectomies are not cost-efficient for German hospitals. Due to longer hospitalization and insufficient reimbursements, EVT is twice as costly as SEMS treatment. An adequate DRG cost compensation is needed for SEMS and EVT.

Endoscopic vacuum therapy for anastomotic leakage after esophagectomy: a retrospective analysis at a tertiary university center

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

BackgroundTraumatic esophageal perforations (TEP) are a grave medical condition and require immediate intervention. Techniques such as Esophageal Self-Expandable Metal Stent (E-SEMS) and Endoscopic Vacuum Therapy (EVT) show promise in reducing tissue damage and controlling esophageal leakage. The present study aims to compare the application of EVT to E-SEMS placement in TEP.MethodsRetrospective cohort study valuated 30 patients with TEP. The E-SEMS and EVT groups were assessed for time of hospitalization, treatment duration, costs, and clinical outcome.ResultsPatients treated with EVT (24.4 ± 13.2) demonstrated significantly shorter treatment duration (p < 0.005) compared to the group treated with E-SEMS (45.8 ± 12.9) and patients submitted to E-SEMS demonstrated a significant reduction (p = 0.02) in the time of hospitalization compared to the EVT (34 ± 2 vs 82 ± 5 days). Both groups demonstrated a satisfactory discharge rate (E-SEMS 93.7% vs EVT 71.4%) but did not show statistically significant difference (p = 0.3155). E-SEMS treatment had a lower mean cost than EVT (p < 0.05). Descriptive statistics were utilized, arranged in table form, where frequencies, percentages, mean, median, and standard deviation of the study variables were calculated and counted. The Fisher's Exact Test was used to evaluate the relationship between two categorical variables. To evaluate differences between means and central points, the parametric t-test was utilized. Comparisons with p value up to 0.05 were considered significant.ConclusionE-SEMS showed a shorter time of hospitalization, but a longer duration of treatment compared to EVT. The placement of E-SEMS and EVT had the same clinical outcome. Treatment with E-SEMS had a lower cost compared with EVT.

A transmural defect of the upper gastrointestinal (UGI) tract is a life-threatening condition associated with high morbidity and mortality. Recently, endoscopic vacuum therapy (EVT) was used for managing UGI defects and showed promising results. We conducted a systematic review and meta-analysis to synthesize evidence on the efficacy of EVT in patients with transmural defects of the UGI tract. We searched the PubMed, Cochrane Library, and Embase databases for publications on the effect of EVT on successful closure, mortality, complications, and post-EVT strictures. Methodological quality was assessed using the Newcastle–Ottawa quality assessment scale. This meta-analysis included 29 studies involving 498 participants. The pooled estimate rate of successful closure with EVT was 0.85 (95% confidence interval [CI]: 0.81–0.88). The pooled estimate rates for mortality, complications, and post-EVT strictures were 0.11, 0.10, and 0.14, respectively. According to the etiology of the transmural defect (perforation vs. leak and fistula), no significant difference was observed in successful closure (odds ratio [OR]: 1.45, 95% CI: 0.45–4.67, p = 0.53), mortality (OR: 0.77, 95% CI: 0.24–2.46, p = 0.66), complications (OR: 0.94, 95% CI: 0.17–5.15, p = 0.94), or post-EVT stricture rates (OR: 0.70, 95% CI: 0.12–4.24, p = 0.70). The successful closure rate was significantly higher with EVT than with self-expanding metal stent (SEMS) placement (OR: 3.14, 95% CI: 1.23–7.98, p = 0.02). EVT is an effective and safe treatment for leaks and fistulae, as well as for perforations in the UGI. Moreover, EVT seems to be a better treatment option than SEMS placement for UGI defects.

Esophagectomy, while a pivotal treatment for esophageal cancer, is not without adverse events. Among these, anastomotic leak (AL) is the most feared complication, threatening patient lives and incurring significant healthcare costs. The management of AL is complex and lacks standardization. Given the high morbidity and mortality rates associated with redo-surgery, which poses risks for already fragile patients, various endoscopic treatments have been developed over time. Self-expandable metallic stents (SEMSs) were the most widely used treatment until the early 2000s. The mechanism of action of SEMSs includes covering the wall defect, protecting it from secretions, and promoting healing. In 2010, endoscopic vacuum therapy (EVT) emerged as a viable alternative for treating ALs, quickly gaining acceptance in clinical practice. EVT involves placing a dedicated sponge under negative pressure inside or adjacent to the wall defect, aiming to clear the leak and promote granulation tissue formation. More recently, the VAC-Stent entered the scenario of endoscopic treatment of post-esophagectomy ALs. This device combines a fully covered SEMS with an integrated EVT sponge, blending the ability of SEMSs to exclude defects and maintain the patency of the esophageal lumen with the capacity of EVT to aspirate secretions and promote the formation of granulation tissue. Although the literature on this new device is not extensive, early results from the application of VAC-Stent have shown promising outcomes. This review aims to synthesize the preliminary efficacy and safety data on the device, thoroughly analyze its advantages over traditional techniques and disadvantages, explore areas for improvement, and propose future directions.