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Background Anastomotic leak (AL) is a common but severe complication after oesophagectomy. It is unknown how to determine the severity of AL objectively at diagnosis. Determining leak severity may guide treatment decisions and improve future research. This study aimed to identify leak-related prognostic factors for mortality, and to develop a Severity of oEsophageal Anastomotic Leak (SEAL) score. Methods This international, retrospective cohort study in 71 centres worldwide included patients with AL after oesophagectomy between 2011 and 2019. The primary endpoint was 90-day mortality. Leak-related prognostic factors were identified after adjusting for confounders and were included in multivariable logistic regression to develop the SEAL score. Four classes of leak severity (mild, moderate, severe, and critical) were defined based on the risk of 90-day mortality, and the score was validated internally. Results Some 1509 patients with AL were included and the 90-day mortality rate was 11.7 per cent. Twelve leak-related prognostic factors were included in the SEAL score. The score showed good calibration and discrimination (c-index 0.77, 95 per cent c.i. 0.73 to 0.81). Higher classes of leak severity graded by the SEAL score were associated with a significant increase in duration of ICU stay, healing time, Comprehensive Complication Index score, and Esophagectomy Complications Consensus Group classification. Conclusion The SEAL score grades leak severity into four classes by combining 12 leak-related predictors and can be used to the assess severity of AL after oesophagectomy.

Purpose Little is known about the optimal treatment of anastomotic leakage after low anterior resection (LAR) for rectal cancer and whether treatment strategy depends on leakage features and patient characteristics. The objective of this study was to determine which treatment principles are used by expert colorectal surgeons worldwide. Methods In this international case-vignette study, participants completed a survey on their preferred treatment for 11 clinical cases with varying leakage features and two patient scenarios depending on surgical risk (a total of 22 cases). Results In total, 42 of 64 invited surgeons completed the survey from 18 countries worldwide. The majority worked at a university training hospital (62%) and had more than 15 years of experience performing LAR for rectal cancer (52%). Early leaks in septic patients were preferably treated by major salvage surgery, to some extent depending on the patient scenario. In early leaks in non-septic patients, drainage and faecal diversion were the cornerstones of the proposed treatment. Endoscopic vacuum therapy was more often proposed than percutaneous drainage. A minority proposed anastomotic reconstruction, more often for larger defects. Treatment of late leaks ranged from watchful waiting, drainage, or transanal repair to major (non-)restorative salvage surgery, with minimal influence of the degree of symptoms on the proposed strategy. Leaks of the blind loop and rectovaginal fistulae showed high variability in the proposed treatment strategy. Conclusion This TENTACLE-Rectum case-vignette study demonstrates tailored treatment strategies depending on the clinical type of leak and patient characteristics, with variable degrees of consensus and knowledge gaps which should be addressed in future studies.

Anastomotic leak (AL) is a common and severe complication after esophagectomy. This study aimed to assess the performance of a consensus-based algorithm for diagnosing AL after minimally invasive esophagectomy. This study used data of the ICAN trial, a multicenter randomized clinical trial comparing cervical and intrathoracic anastomosis, in which a predefined diagnostic algorithm was used to guide diagnosing AL. The algorithm identified patients suspected of AL based on clinical signs, blood C-reactive protein (cut-off value 200 mg/L), and/or drain amylase (cut-off value 200 IU/L). Suspicion of AL prompted evaluation with contrast swallow computed tomography and/or endoscopy to confirm AL. Primary outcome measure was algorithm performance in terms of sensitivity, specificity, and positive and negative predictive values (PPV, NPV), respectively. AL was defined according to the definition of the Esophagectomy Complications Consensus Group. 245 patients were included, and 125 (51%) patients were suspected of AL. The algorithm had a sensitivity of 62% (95% confidence interval [CI]: 46–75), a specificity of 97% (95% CI: 89–100), and a PPV and NPV of 94% (95% CI: 79–99) and 77% (95% CI: 66–86), respectively, on initial assessment. Repeated assessment in 19 patients with persisting suspicion of AL despite negative or inconclusive initial assessment had a sensitivity of 100% (95% CI: 77–100). The algorithm showed poor performance because the low sensitivity indicates the inability of the algorithm to confirm AL on initial assessment. Repeated assessment using the algorithm was needed to confirm remaining leaks.

Contains fulltext : 288475.pdf (Publisher’s version ) (Open Access) Anastomotic leak (AL) is a severe complication after esophagectomy. Clinical presentation of AL is diverse and there is large practice variation regarding treatment of AL. This study aimed to explore different AL treatment strategies and their underlying rationale. This mixed-methods study consisted of an international survey among upper gastro-intestinal (GI) surgeons and focus groups with expert upper GI surgeons. The survey included 10 case vignettes and data sources were integrated after separate analysis. The survey was completed by 188 respondents (completion rate 69%) and 6 focus groups were conducted with 20 international experts. Prevention of mortality was the most important goal of primary treatment. Goals of secondary treatment were to promote tissue healing, return to oral feeding and safe hospital discharge. There was substantial variation in the preferred treatment principles (e.g. drainage or defect closure) and modalities (e.g. stent or endoVAC) within different presentations of AL. Patients with local symptoms were treated by supportive means only or by non-surgical drainage and/or defect closure. Drainage was routinely performed in patients with intrathoracic collections and often combined with defect closure. Patients with conduit necrosis were predominantly treated by resection and reconstruction of the anastomosis or by esophageal diversion. This mixed-methods study shows that overall treatment strategies for AL are determined by vitality of the conduit and presence of intrathoracic collections. There is large variation in preferred treatment principles and modalities. Future research may investigate optimal treatment for specific AL presentations and aim to develop consensus-based treatment guidelines for AL after esophagectomy.

Contains fulltext : 237885.pdf (Publisher’s version ) (Closed access) BACKGROUND: Transthoracic minimally invasive esophagectomy (MIE) is increasingly performed as part of curative multimodality treatment. There appears to be no robust evidence on the preferred location of the anastomosis after transthoracic MIE. OBJECTIVE: To compare an intrathoracic with a cervical anastomosis in a randomized clinical trial. DESIGN, SETTING, AND PARTICIPANTS: This open, multicenter randomized clinical superiority trial was performed at 9 Dutch high-volume hospitals. Patients with midesophageal to distal esophageal or gastroesophageal junction cancer planned for curative resection were included. Data collection occurred from April 2016 through February 2020. INTERVENTION: Patients were randomly assigned (1:1) to transthoracic MIE with intrathoracic or cervical anastomosis. MAIN OUTCOMES AND MEASURES: The primary end point was anastomotic leakage requiring endoscopic, radiologic, or surgical intervention. Secondary outcomes were overall anastomotic leak rate, other postoperative complications, length of stay, mortality, and quality of life. RESULTS: Two hundred sixty-two patients were randomized, and 245 were eligible for analysis. Anastomotic leakage necessitating reintervention occurred in 15 of 122 patients with intrathoracic anastomosis (12.3%) and in 39 of 123 patients with cervical anastomosis (31.7%; risk difference, -19.4% [95% CI, -29.5% to -9.3%]). Overall anastomotic leak rate was 12.3% in the intrathoracic anastomosis group and 34.1% in the cervical anastomosis group (risk difference, -21.9% [95% CI, -32.1% to -11.6%]). Intensive care unit length of stay, mortality rates, and overall quality of life were comparable between groups, but intrathoracic anastomosis was associated with fewer severe complications (risk difference, -11.3% [-20.4% to -2.2%]), lower incidence of recurrent laryngeal nerve palsy (risk difference, -7.3% [95% CI, -12.1% to -2.5%]), and better quality of life in 3 subdomains (mean differences: dysphagia, -12.2 [95% CI, -19.6 to -4.7]; problems of choking when swallowing, -10.3 [95% CI, -16.4 to 4.2]; trouble with talking, -15.3 [95% CI, -22.9 to -7.7]). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, intrathoracic anastomosis resulted in better outcome for patients treated with transthoracic MIE for midesophageal to distal esophageal or gastroesophageal junction cancer. TRIAL REGISTRATION: Trialregister.nl Identifier: NL4183 (NTR4333).

Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer planned for curative resection were recruited. Eligible patients were randomly assigned (1:1) to either Ivor Lewis MIE or McKeown MIE. The primary endpoint was anastomotic leakage (AL) requiring endoscopic, radiologic or surgical intervention. Secondary outcome parameters were overall AL rate, postoperative complications, length of stay and mortality. Results A total of 262 patients were randomly assigned to Ivor Lewis MIE (n = 130) or McKeown MIE (n = 132). Seventeen patients were excluded due to not meeting inclusion criteria (n = 2), physical unfitness for surgery (n = 3), patients’ choice (n = 3), interval metastases (n = 5) or peroperative metastases (n = 4). AL necessitating reintervention occurred in 15 (12.3%) of 122 patients after Ivor Lewis MIE and in 39 (31.7%) of 123 patients after McKeown MIE (RR 0.39, 95%CI 0.22–0.65). Severe complications (Clavien-Dindo ≥3b) were observed in 10.7% after Ivor Lewis MIE and in 22.0% after McKeown MIE (RR 0.49, 95%CI 0.25–0.88). Conclusion This study provides evidence for a lower rate of AL requiring reintervention after Ivor Lewis MIE compared to McKeown MIE for patients with mid to distal esophageal or GEJ cancer.

Anastomotic leakage (AL) is a common and severe complication after esophagectomy. It is largely unknown which primary treatments are most effective for which type of leak. We aimed to investigate the effectiveness of different primary treatments of AL. Methods International retrospective cohort study, in which patients with AL after esophagectomy with gastric tube reconstruction were included in the period 2011-2019. Detailed data regarding case mix, resection, leakage characteristics (e.g. organ failure, leak circumference, contamination, drains present) and leakage treatment (e.g. hours from diagnosis to treatment, primary and secondary treatment modalities) were collected. Primary outcome was 90-day mortality and secondary outcomes included length of stay and leak healing time. Different clinically relevant leakage groups have been defined. Efficacy of different treatment strategies adjusted for leakage severity will be analyzed in these clinical groups. The study protocol is accessible at www.tentaclestudy.com. Results Detailed data of 1451 patients with AL was collected from 71 centers in 20 countries. Data accuracy was 96.5%. Preliminary results showed that the overall 90-day mortality was 11.6%. The analysis of TENTACLE—Esophagus data is currently being performed and efficacy of different leakage treatment strategies is being assessed. The efficacy of initial leakage treatment strategies will be ready to be presented at the ISDE meeting. Conclusion This is the largest study on effectiveness of AL treatments. The final results of initial leak treatments, which will be available for presentation at the ISDE meeting, could provide an evidence-based basis that can be used by clinicians to determine the preferred primary treatment strategy in patients with a given type of anastomotic leakage.

Anastomotic leakage (AL) is a common and potentially life-threatening complication after esophagectomy. In patients with AL it is largely unknown which patient parameters and leakage characteristics are associated with leak severity and mortality. We aimed to identify prognostic factors for mortality in patients with anastomotic leakage after esophagectomy. Methods The TENTACLE—Esophagus study is an international retrospective cohort study, in which 1451 patients with AL after esophagectomy between 2011 and 2019 were included in 71 centers from 20 countries. Potential prognostic factors were selected from literature and a hypothetical association with mortality. Confounders of (individual) prognostic factors were identified using a directed acyclic graph approach to minimize bias. Primary outcome was 90-day mortality. Logistic regression analysis was performed to estimate crude and adjusted odds ratios (AOR) and 95% confidence intervals (95%CI). The study protocol is accessible at www.tentaclestudy.com. Results Overall 90-day mortality rate was 11.6%. Leakage characteristics with the largest prognostic effect on mortality were gastric conduit ischemia/necrosis (AOR 2.23, 95%CI 1.43-3.49), defect circumference ≥ 25% (AOR 2.10, 95%CI 1.32-3.36) and intrathoracic fluid collections (drained AOR 1.98, 95%CI 1.05-3.75; undrained AOR 2.43, 95%CI 1.57-3.75). Patient parameters with the largest prognostic effect were ASA-score ≥ 3 (AOR 4.18, 95%CI 1.67-10.51), ECOG-score ≥ 2 (AOR 2.83, 95%CI 1.56-5.14) and respiratory failure (AOR 3.89, 95%CI 2.67-5.66), hemodynamic failure (AOR 3.09, 95%CI 1.96-4.88) or renal failure (AOR 4.08, 95%CI 2.20-7.59) at time of AL diagnosis. Conclusion Defect circumference, intrathoracic fluid collections, gastric conduit condition and several patient parameters were identified as prognostic factors for mortality in patients with AL. Adjusting for these prognostic factors may reduce confounding bias in future studies assessing efficacy of AL treatments. The identified prognostic factors contribute to the understanding of the severity of anastomotic leakage after esophagectomy and may be used to recognize the severity of an anastomotic leak in individual patients.

IntroductionGrowing evidence is showing that complicated and uncomplicated appendicitis are two different entities that may be treated differently. A correct diagnosis of the type of appendicitis is therefore essential. The Scoring system of Appendicitis Severity (SAS) combines clinical, laboratory and imaging findings. The SAS rules out complicated appendicitis in 95% (negative predictive value, NPV) and detects 95% (sensitivity) of patients with complicated appendicitis in adults suspected of acute appendicitis. However, this scoring system has not yet been validated externally. In this study, we aim to provide a prospective external validation of the SAS in a new cohort of patients with clinical suspicion of appendicitis. We will optimise the score when necessary.Methods and analysisThe SAS will be validated in 795 consecutive adult patients diagnosed with acute appendicitis confirmed by imaging. Data will be collected prospectively in multiple centres. The predicted diagnosis based on the SAS score will be compared with the combined surgical and histological diagnosis. Diagnostic accuracy for ruling out complicated appendicitis will be calculated. If the SAS does not reach a sensitivity and NPV of 95% in its present form, the score will be optimised. After optimisation, a second external validation will be performed in a new group of 328 patients. Furthermore, the diagnostic accuracy of the clinical perspective of the treating physician for differentiation between uncomplicated and complicated appendicitis and the patient’s preferences for different treatment options will be assessed.Ethics and disseminationEthical approval was granted by the Amsterdam UMC Medical Ethics Committee (reference W19_416 # 19.483). Because of the observational nature of this study, the study does not fall under the scope of the Medical Research Involving Human Subjects Act. Results will be presented in peer-reviewed journals. This protocol is submitted for publication before analysis of the results.

Anastomotic leakage (AL) is a common and severe complication after esophagectomy. It is largely unknown which initial treatments are most effective for what type of leak. We aimed to investigate the effectiveness of initial treatments of AL in daily clinical practice. Methods The TENTACLE—Esophagus is a multinational retrospective cohort study, in which patients with AL after esophagectomy with gastric tube reconstruction in the period 2011–2019 were included. Detailed data regarding casemix, surgery, leak characteristics (e.g. organ failure, leak circumference, contamination, drains present) and treatment (e.g. hours from diagnosis to treatment, treatment modalities) were collected. Primary outcome was 90-day mortality and secondary outcomes included length of stay and leak healing time. Regression analysis will be used to analyze the effectiveness of primary treatments after correction for patient-, surgery- and leak characteristics. The full study protocol is accessible at www.tentaclestudy.com. Results Detailed data of 1407 patients with AL from 70 centers in 20 countries is currently being validated and is awaiting final analysis. Preliminary results showed that AL was diagnosed 0–43 days after surgery and 90-day mortality rate was 11.1%. Primary treatments included re-operation (23.0%), stenting (16.8%), radiological drainage (10.5%), tube placement through the defect in the leak cavity (8.7%) and endoVAC placement (3.4%). Re-operations (n = 323) were drainage only (54.6%), oversewing the leak (15.5%), anastomotic resection and re-anastomosis (5,3%), repair with muscle flap (2.5%), disconnection and esophagostomy (11.8%) and other or unknown procedures (10.3%). Conclusion This is the largest study on effectiveness of AL treatments. The final results of initial leak treatments, which will be available for presentation at the ISDE meeting, could provide an evidence based basis that can be used by clinicians to determine the preferred primary treatment strategy in patients with a given type of AL.