Robotic Techniques in Esophagogastric Cancer Surgery: An Assessment of Short- and Long-Term Clinical Outcomes.

BACKGROUND: Robotic esophagogastric cancer surgery is gaining widespread adoption. This population-based cohort study aimed to compare rates of textbook outcomes (TOs) and survival from robotic minimally invasive techniques for esophagogastric cancer. METHODS: Data from the United States National Cancer Database (NCDB) (2010-2017) were used to identify patients with non-metastatic esophageal or gastric cancer receiving open surgery (to the esophagus, n = 11,442; stomach, n = 22,183), laparoscopic surgery (to the esophagus [LAMIE], n = 4827; stomach [LAMIG], n = 6359), or robotic surgery (to the esophagus [RAMIE], n = 1657; stomach [RAMIG], n = 1718). The study defined TOs as 15 or more lymph nodes examined, margin-negative resections, hospital stay less than 21 days, no 30-day readmissions, and no 90-day mortalities. Multivariable logistic regression and Cox analyses were used to account for treatment selection bias. RESULTS: Patients receiving robotic surgery were more commonly treated in high-volume academic centers with advanced clinical T and N stage disease. From 2010 to 2017, TO rates increased for esophageal and gastric cancer treated via all surgical techniques. Compared with open surgery, significantly higher TO rates were associated with RAMIE (odds ratio [OR], 1.41; 95% confidence interval [CI], 1.27-1.58) and RAMIG (OR 1.30; 95% CI 1.17-1.45). For esophagectomy, long-term survival was associated with both TO (hazard ratio [HR 0.64, 95% CI 0.60-0.67) and RAMIE (HR 0.92; 95% CI 0.84-1.00). For gastrectomy, long-term survival was associated with TO (HR 0.58; 95% CI 0.56-0.60) and both LAMIG (HR 0.89; 95% CI 0.85-0.94) and RAMIG (HR 0.88; 95% CI 0.81-0.96). Subset analysis in high-volume centers confirmed similar findings. CONCLUSION: Despite potentially adverse learning curve effects and more advanced tumor stages captured during the study period, both RAMIE and RAMIG performed in mostly high-volume centers were associated with improved TO and long-term survival. Therefore, consideration for wider adoption but a well-designed phase 3 randomized controlled trial (RCT) is required for a full evaluation of the benefits conferred by robotic techniques for esophageal and gastric cancers.

Randomised controlled trial to establish the clinical and cost-effectiveness of expectant management versus preoperative imaging with magnetic resonance cholangiopancreatography in patients with symptomatic gallbladder disease undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones (The Sunflower Study): a study protocol.

INTRODUCTION: Surgery to remove the gallbladder (laparoscopic cholecystectomy (LC)) is the standard treatment for symptomatic gallbladder disease. One potential complication of gallbladder disease is that gallstones can pass into the common bile duct (CBD) where they may remain dormant, pass spontaneously into the bowel or cause problems such as obstructive jaundice or pancreatitis. Patients requiring LC are assessed preoperatively for their risk of CBD stones using liver function tests and imaging. If the risk is high, guidelines recommend further investigation and treatment. Further investigation of patients at low or moderate risk of CBD stones is not standardised, and the practice of imaging the CBD using magnetic resonance cholangiopancreatography (MRCP) in these patients varies across the UK. The consequences of these decisions may lead to overtreatment or undertreatment of patients. METHODS AND ANALYSIS: We are conducting a UK multicentre, pragmatic, open, randomised controlled trial with internal pilot phase to compare the effectiveness and cost-effectiveness of preoperative imaging with MRCP versus expectant management (ie, no preoperative imaging) in adult patients with symptomatic gallbladder disease undergoing urgent or elective LC who are at low or moderate risk of CBD stones. We aim to recruit 13 680 patients over 48 months. The primary outcome is any hospital admission within 18 months of randomisation for a complication of gallstones. This includes complications of endoscopic retrograde cholangiopancreatography for the treatment of gallstones and complications of LC. This will be determined using routine data sources, for example, National Health Service Digital Hospital Episode Statistics for participants in England. Secondary outcomes include cost-effectiveness and patient-reported quality of life, with participants followed up for a median of 18 months. ETHICS AND DISSEMINATION: This study received approval from Yorkshire & The Humber - South Yorkshire Research Ethics Committee. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10378861.

Quality of life and symptom assessment in paraesophageal hernias: a systematic literature review of reporting standards.

BACKGROUND: Paraesophageal hernias (PEH) present with a range of symptoms affecting physical and mental health. This systematic review aims to assess the quality of reporting standards for patients with PEH, identify the most frequently used quality of life (QOL) and symptom severity assessment tools in PEH and to ascertain additional symptoms reported by these patients not captured by these tools. METHODS: A systematic literature review according to PRISMA protocols was carried out following a literature search of MEDLINE, Embase and Cochrane databases for studies published between January 1960 and May 2020. Published abstracts from conference proceedings were included. Data on QOL tools used and reported symptoms were extracted. RESULTS: This review included 220 studies reporting on 28 353 patients. A total of 46 different QOL and symptom severity tools were used across all studies, and 89 different symptoms were reported. The most frequently utilized QOL tool was the Gastro-Esophageal Reflux Disease-Health related quality of life questionnaire symptom severity instrument (47.7%), 57.2% of studies utilized more than 2 QOL tools and 'dysphagia' was the most frequently reported symptom, in 55.0% of studies. Notably, respiratory and cardiovascular symptoms, although less common than GI symptoms, were reported and included 'dyspnea' reported in 35 studies (15.9%). CONCLUSIONS: There lacks a QOL assessment tool that captures the range of symptoms associated with PEH. Reporting standards for this cohort must be improved to compare patient outcomes before and after surgery. Further investigations must seek to develop a PEH specific tool, that encompasses the relative importance of symptoms when considering surgical intervention and assessing symptomatic improvement following surgery.

Validation of the NUn score as a predictor of anastomotic leak and major complications after Esophagectomy.

Predicting major anastomotic leak (AL) and major complications (Clavien-Dindo 3-5) following esophagectomy improves postoperative management of patients. The role of the NUn score in their prediction is controversial. This study aims to evaluate the predictive ability of this simple score. Data were retrospectively collected for consecutive esophagectomies over a 10-year period, and NUn scores were retrospectively calculated for each patient from informatics data. A standardized definition of major AL was used, excluding minor asymptomatic, radiologically detected leaks. The predictive accuracy of the NUn score and its constituent parts, for major AL and major complications, was assessed using area under receiver operating characteristics curves (AUROCs). Of 382 patients, 48 (13%) developed major AL and 123 (32%) developed major complications. The NUn score calculated on postoperative day 4 was significantly predictive of both outcomes, with AUROCs of 0.77 and 0.71, respectively (both P < 0.001). A NUn score cut-off of 10 had a negative predictive value of 95% for major AL. The NUn score was predictive of major complications on multivariable analysis. The NUn score was found to be a significant predictor of major AL, suggesting that this is a useful early warning score for major AL. The score may also be useful in identifying patients that are the most likely to benefit from enhanced recovery protocols.

Should routine assessment of anastomotic integrity be undertaken using radiological contrast swallow after oesophagectomy with intra-thoracic anastomosis? Best evidence topic (BET).

Thoracic anastomotic leak is associated with significant postoperative morbidity and mortality. Routine contrast oesophagograms are consequently employed by a number of centres to routinely screen for this complication yet there exists little consensus as to if and when this assessment should occur. We have demonstrated within this BestBET analysis of five level IV case series that routine contrast oesophagograms lack adequate sensitivity or positive predictive value to be effective as screening tools, with leaks often arising clinically prior to scheduled routine assessment. We additionally demonstrate the significant risk of aspiration associated with contrast swallow use. The use of contrast swallow studies as diagnostic tools in patients for whom a leak is considered likely on the basis of clinical examination is nevertheless supported by relatively greater negative predictive values and specificity reported within the literature. There is additional evidence to support the use of CT imaging with oral contrast and endoscopic assessment of the anastomosis as valuable tools to assess for anastomotic integrity.

Should routine radiological assessment of anastomotic integrity be performed after oesophagectomy with cervical anastomosis? Best evidence topic (BET).

Rates of anastomotic leak in patients who undergo oesophagectomy with cervical anastomosis formation are reported within the literature to surpass those of patients undergoing thoracic anastomosis formation. Though preferred by a number of surgeons, cervical anastomosis is associated with higher rates of anastomotic leak, the consequences of which can be severe. Routine contrast oesophagograms are therefore utilised in a number of institutions as a means of recognising leaks early. They are not without potential complications, however, and the predictive value of contrast imaging has previously been debated. This best evidence topic reviews the use of contrast oesophagograms in screening for cervical anastamotic leak, concluding that their inherent risk of aspiration combined with poor sensitivity should preclude their use as a screening tool. High rates of specificity nevertheless indicate the potential utility of these studies in patients for whom there is clinical suspicion of a leak.

FGFR2, HER2 and cMet in gastric adenocarcinoma: detection, prognostic significance and assessment of downstream pathway activation.

Receptor tyrosine kinase pathways are potential therapeutic targets in gastric adenocarcinoma patients. We evaluated HER2 and cMet protein expression, and FGFR2 gene amplification to assess their prognostic significance, and downstream mediators pS6 and pERK for their potential utility as pharmacodynamic biomarkers in patients with gastric adenocarcinoma. Tissue microarrays were constructed from resection samples of 184 patients who underwent surgery for gastric/gastro-oesophageal junction adenocarcinoma. Tissue cores were obtained from the tumour body (TB), luminal surface (LS) and invasive edge (IE), and immunohistochemical and fluorescence in situ hybridisation (FGFR2) analysis was performed. FGFR2 amplification was identified in 2 % of cases and associated with worse survival (P = 0.005). HER2 overexpression was observed in 10 % of cases and associated with increased survival (P = 0.041). cMet overexpression was observed in 4 % of cases and associated with worse survival (P < 0.001). On multivariate analysis, only cMet retained significance (P = 0.006). pS6 and pERK expression were observed in 73 % and 30 % of tumours, respectively, with no association with survival. HER2 (P = 0.004) and pERK (P = 0.001) expression differed between tumour regions with HER2 expression increased in the LS compared with the TB and IE. These findings confirm subpopulations in gastric adenocarcinoma with poor outcome that may benefit from specific therapeutic strategies. However, we found heterogeneous HER2, pS6 and pERK overexpression, which presents challenges for their use as predictive biomarkers in gastric biopsies. The potential downstream pharmacodynamic markers pS6 and pERK were expressed across tumour regions, providing evidence that resections and biopsies would yield comparative results in clinical trials.

An assessment of radiologically inserted transoral and transgastric gastroduodenal stents to treat malignant gastric outlet obstruction.

INTRODUCTION: Self-expanding metallic stents (SEMS) are used to palliate malignant gastric outlet obstruction (GOO) and are useful in patients with limited life expectancy or severe medical comorbidity, which would preclude surgery. Stenting can be performed transorally or by a percutaneous transgastric technique. Our goal was to review the outcome of patients who underwent radiological SEMS insertion performed by a single consultant interventional radiologist. METHODS: Patients were identified from a prospectively collected database held by one consultant radiologist. Data were retrieved from radiological reports, multidisciplinary team meetings, and the patients' case notes. Univariate survival analysis was performed. RESULTS: Between December 2000 and January 2011, 100 patients (63 males, 37 females) had 110 gastroduodenal stenting procedures. Median age was 73 (range 39-89) years. SEMS were inserted transorally (n = 66) or transgastrically (n = 44). Site of obstruction was the stomach (n = 37), duodenum (n = 50), gastric pull-up (n = 10), or gastroenterostomy (n = 13). Seven patients required biliary stents. Technical success was 86.4 %: 83.3 % for transoral insertion, 90.9 % for transgastric insertion. Eleven patients developed complications. Median GOO severity score: 1 pre-stenting, 2 post-stenting (p = 0.0001). Median survival was 54 (range 1-624) days. Post-stenting GOO severity score was predictive of survival (p = 0.0001). CONCLUSIONS: The technical success rate for insertion of palliative SEMS is high. Insertional technique can be tailored to the individual depending on the location of the tumor and whether it is possible to access the stomach percutaneously. Patients who have successful stenting and return to eating a soft/normal diet have a statistically significant increase in survival.