Transgastric drainage of the perforated esophagus: our experiences over 10 years.

We first described the technique of transgastric drainage of esophageal injuries in 2008. The method establishes vacuum drainage of the lumen of the esophagus, while maintaining patency, effectively exteriorizing the perforation to allow healing. We summarize this technique and present our experiences from the largest published series of patients. Our unit has treated selected esophageal injuries with transgastric drainage for 10 years. Indications include perforations not amenable to primary repair and treatment failure following prior surgical intervention. A 36 French silastic chest drain is pulled through the abdominal and stomach wall and introduced into the esophagus so that it crosses the perforation. Gastropexy is performed. Mediastinal decontamination and drainage are performed as needed. Continuous suction of -10 cm water is applied. Leak resolution is assessed with weekly water-soluble swallows. For this retrospective observational study, we analyzed data for patients with esophageal perforation, between 2012 and 2022. Inpatient mortality and time to leak resolution were set as primary and secondary outcomes. Esophageal perforations were treated with transgastric drain in 35 patients, of whom 68% (n = 24) were men. Median age was 67 (26-84). Spontaneous perforations accounted for 60% (n = 21), 31% (n = 11) were iatrogenic and 6% (n = 2) were ischemic. Inpatient and 30-day mortality was 14% (n = 5). Among successful treatments, the median length to resolution of leak on imaging was 34.5 days (6-80). Transgastric drainage can successfully treat esophageal perforations, where primary repair is not feasible. The mortality rate of 14% and reduced morbidity compares favorably with other traditional methods of management for esophageal perforation.

Systematic review of quality of life after esophagectomy and total gastrectomy in patients with gastro-esophageal junction cancer.

The optimal management of cancer of the gastro-esophageal junction (GEJ) is an area of contention. GEJ tumors are typically resected via total gastrectomy or esophagectomy. Despite many studies aiming to determine the superiority of either procedure based on surgical or oncological outcomes, the evidence is equivocal. Data focusing specifically on quality of life (QoL), however, is limited. This systematic review was performed to determine if there is any difference in patient's QoL after total gastrectomy or esophagectomy. A systematic search of PubMed, Medline and Cochrane libraries was conducted for literature published between 1986 and 2023. Studies that used the internationally validated questionnaires EORTC QLQ-C30 and EORTC-QLQ-OG25, to compare QoL after esophagectomy to gastrectomy for the management of GEJ cancer were included. Five studies involving 575 patients undergoing either esophagectomy (n = 365) or total gastrectomy (n = 210) for GEJ tumors were included. QoL was predominantly assessed at 6, 12 and 24 months postoperatively. Although individual studies demonstrated significant differences in certain domains, these differences were not consistently demonstrated in more than one study. There is no evidence to suggest any significant differences in QoL after total gastrectomy compared to esophagectomy for management of gastro-esophageal junction cancer.

Oesophagectomy or Total Gastrectomy for the Management of Siewert II Gastroesophageal Junction Cancer: a Systematic Review and Meta-analysis.

BACKGROUND: There is no consensus on the ideal surgical management of patients with Siewert type II gastroesophageal junctional (GEJ) cancers. Due to its anatomical location, total gastrectomy and oesophagectomy are widely used methods of resection. The aim of this study was to determine the optimal surgical treatment of these patients. METHOD: A systematic search of PubMed, Medline and Cochrane libraries was conducted for literature published between 2000 and 2022. Studies directly comparing oesophagectomy to gastrectomy for Siewert type II tumours were included. Outcome measures included rates of anastomotic leak, 30-day mortality, R0 resection and 5-year survival. Statistical analysis was performed using Review Manager 5.4. RESULTS: Eleven studies involving 18,585 patients undergoing either oesophagectomy (n = 8618) or total gastrectomy (n = 9967) for Siewert type II GEJ cancer were included. There were no significant differences between the rates of anastomotic leak (OR 0.91, CI 0.59-1.40, p = 0.66) and R0 resection (OR 1.51, CI 0.93-2.42, p = 0.09). Patients undergoing total gastrectomy had a lower 30-day mortality (OR 0.66, CI 0.45-0.95, p = 0.03) and a greater 5-year overall survival (OR 1.49, CI 1.34-1.67, p < 0.001) compared to patients undergoing oesophagectomy. These differences were not statistically significant after excluding two large studies, which accounted for the majority of the total population in the analysis. CONCLUSION: These results suggest that total gastrectomy results in lower 30-day mortality and improved overall survival in patients with Siewert type II GEJ cancer. However, interpretation of these results may be biased by the effect of two large studies.

Gut hormones profile after an Ivor Lewis gastro-esophagectomy and its relationship to delayed gastric emptying.

Delayed gastric emptying (DGE) is common after an Ivor Lewis gastro-esophagectomy (ILGO). The risk of a dilated conduit is the much-feared anastomotic leak. Therefore, prompt management of DGE is required. However, the pathophysiology of DGE is unclear. We proposed that post-ILGO patients with/without DGE have different gut hormone profiles (GHP). Consecutive patients undergoing an ILGO from 1 December 2017 to 31 November 2019 were recruited. Blood sampling was conducted on either day 4, 5, or 6 with baseline sample taken prior to a 193-kcal meal and after every 30 minutes for 2 hours. If patients received pyloric dilatation, a repeat profile was performed post-dilatation and were designated as had DGE. Analyses were conducted on the following groups: patient without dilatation (non-dilated) versus dilatation (dilated); and pre-dilatation versus post-dilatation. Gut hormone profiles analyzed were glucagon-like peptide-1 (GLP-1) and peptide tyrosine tyrosine (PYY) using radioimmunoassay. Of 65 patients, 24 (36.9%) had dilatation and 41 (63.1%) did not. For the non-dilated and dilated groups, there were no differences in day 4, 5, or 6 GLP-1 (P = 0.499) (95% confidence interval for non-dilated [2822.64, 4416.40] and dilated [2519.91, 3162.32]). However, PYY levels were raised in the non-dilated group (P = 0.021) (95% confidence interval for non-dilated [1620.38, 3005.75] and dilated [821.53, 1606.18]). Additionally, after pyloric dilatation, paired analysis showed no differences in GLP-1, but PYY levels were different at all time points and had an exaggerated post-prandial response. We conclude that DGE is associated with an obtunded PYY response. However, the exact nature of the association is not yet established.

Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials.

OBJECTIVE: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts. SUMMARY OF BACKGROUND DATA: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence. METHODS: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory. RESULTS: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700. CONCLUSIONS: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials. ETHICAL APPROVAL: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.

Systematic review and meta-analysis of the influence of prophylactic pyloric balloon dilatation in the prevention of early delayed gastric emptying after oesophagectomy.

BACKGROUND: Early delayed gastric emptying (DGE) occurs in up to 50% of patients following oesophagectomy, which can contribute to increased anastomotic leak and respiratory infection rates. Although the treatment of DGE in the form of pyloric balloon dilatation (PBD) post-operatively is well established, there is no consensus on the optimal approach in the prevention of DGE. The aim of this review was to determine the efficacy of prophylactic PBD in the prevention of DGE following oesophagectomy. METHOD: PubMed, MEDLINE and the Cochrane Library (January 1990 to April 2021) were searched for studies reporting the outcomes of prophylactic PBD in patients who underwent oesophagectomy. The primary outcome measure was the rate of DGE. Secondary outcome measures include anastomotic leak rate and length of hospital stay. RESULTS: Three studies with a total of 203 patients [mean age 63 (26-82) years, 162 males (79.8%)] were analyzed. PBD with a 20-mm balloon was performed in 165 patients (46 patients had PBD and botox therapy) compared with 38 patients who had either no intervention or botox alone (14 patients). The pooled rates of early DGE [16.27%, 95% CI (12.29-20.24) vs. 39.02% (38.87-39.17) (P < 0.001)] and anastomotic leak [8.55%, 95% CI (8.51-8.59) vs. 12.23% (12.16-12.31), P < 0.001] were significantly lower in the PBD group. CONCLUSION: Prophylactic PBD with a 20-mm balloon significantly reduced the rates of early delayed gastric emptying and anastomotic leak following oesophagectomy.

Nutritional deficiency post esophageal and gastric cancer surgery: A quality improvement study.

BACKGROUND: Esophagectomy or gastrectomy for malignant tumors can have a profound effect on nutritional status of patients undergoing the procedure. Hence, postoperative nutritional status is an important prognostic factor to consider in ensuring optimal recovery. In this study, we looked at assessing the prevalence of micronutrient deficiencies post esophagectomy or gastrectomies and the efficiency of Allied Health Professionals (AHP) led clinics in identifying and appropriately managing the deficiencies. METHOD: Between February 2017 and February 2018, all patients who attended the AHP clinic, had micronutrient screening, which includes ferritin, folate, vitamin B12 and vitamin D. Patients were screened for exocrine pancreatic insufficiency (EPI) through series of questions related to symptoms of EPI including steatorrhea, flatulence and urgency to defecate. All patients included in the study were started on A-Z multivitamin tablets from their first visit. Patients reporting symptoms indicative of EPI were started on Creon. Patients found deficient in any micronutrients were invited for a follow-up measurement of the respective deficiency. RESULTS: A total of 63 patients were included in the study period with a median follow-up of 18 months (range: 2-60 months) post esophagectomy and/or subtotal/total gastrectomy for malignant tumors. Proportion of patients with deficiency in ferritin, folate, vitamin B12 and vitamin D were 42.86%, 9.52%, 6.35% and 36.67% respectively. The proportion of patients identified with symptoms indicative of EPI was 31.75%. At re-test follow-up, 66.67% patient noticed settlement of symptoms of EPI. Ferritin, Folate, Vitamin B12 and D levels significantly improved post initial AHP follow-up (significance level p < 0.05). CONCLUSION: This study highlights that nutritional deficiencies post esophagectomy and/or subtotal/total gastrectomy for malignant tumors are prevalent. AHP run follow-up clinics in our unit helps identify these deficiencies and manage them accordingly. This study shows statistically significant improvement in deficiencies thereby making AHP led follow-up clinics to be cost effective and improve patient outcome.

Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT).

INTRODUCTION: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life. METHODS AND ANALYSIS: We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery. ETHICS AND DISSEMINATION: This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10386621.

How to select patients for antireflux surgery? The ICARUS guidelines (international consensus regarding preoperative examinations and clinical characteristics assessment to select adult patients for antireflux surgery).

OBJECTIVE: Antireflux surgery can be proposed in patients with GORD, especially when proton pump inhibitor (PPI) use leads to incomplete symptom improvement. However, to date, international consensus guidelines on the clinical criteria and additional technical examinations used in patient selection for antireflux surgery are lacking. We aimed at generating key recommendations in the selection of patients for antireflux surgery. DESIGN: We included 35 international experts (gastroenterologists, surgeons and physiologists) in a Delphi process and developed 37 statements that were revised by the Consensus Group, to start the Delphi process. Three voting rounds followed where each statement was presented with the evidence summary. The panel indicated the degree of agreement for the statement. When 80% of the Consensus Group agreed (A+/A) with a statement, this was defined as consensus. All votes were mutually anonymous. RESULTS: Patients with heartburn with a satisfactory response to PPIs, patients with a hiatal hernia (HH), patients with oesophagitis Los Angeles (LA) grade B or higher and patients with Barrett's oesophagus are good candidates for antireflux surgery. An endoscopy prior to antireflux surgery is mandatory and a barium swallow should be performed in patients with suspicion of a HH or short oesophagus. Oesophageal manometry is mandatory to rule out major motility disorders. Finally, oesophageal pH (±impedance) monitoring of PPI is mandatory to select patients for antireflux surgery, if endoscopy is negative for unequivocal reflux oesophagitis. CONCLUSION: With the ICARUS guidelines, we generated key recommendations for selection of patients for antireflux surgery.

Prospective cohort study of neoadjuvant therapy toxicity in the treatment of oesophageal adenocarcinoma.

BACKGROUND: Early studies investigating the benefits of neoadjuvant therapy in oesophageal cancer showed conflicting results, taking many years before a survival advantage was demonstrated in randomised trials. Gains are modest, limited by progressive disease and toxicity. This study aimed to investigate the relationship between neoadjuvant therapy-associated toxicity and clinical outcomes including survival in patients with potentially curable oesophageal adenocarcinoma. MATERIALS AND METHODS: A cohort of 286 patients undergoing neoadjuvant therapy followed by surgical resection at a single institution was identified from a prospective database. Adverse events from neoadjuvant therapy were recorded and graded. Patients were divided into two groups according to whether they suffered toxicity or not. Clinical outcomes including whether patients completed the neoadjuvant course, whether they proceeded to resection and overall survival, were compared between the groups. RESULTS: Neoadjuvant therapy-related toxicity was identified in 67/286 patients. 46 patients suffered severe, life-threatening or fatal adverse events. In patients with toxicity, 47% did not complete the chemotherapy course compared to 17% without toxicity, RR 2.7 (95%CI 1.7-4.4), (P < 0.001). In patients suffering toxicity, 17.9% failed to proceed to resection compared with 7.8% in those without toxicity, RR 2.3 (95%CI 1.2-4.6) P = 0.02. Median overall survival was shorter in patients suffering toxicity (20.7 months) compared to those without toxicity (37.8 months), P = 0.008. When patients failing to proceed to resection were excluded, median overall survival was shorter in patients suffering toxicity (26.2 months) compared with those without toxicity (47.8), P = 0.039. CONCLUSION: Neoadjuvant therapy-related toxicity is common and can have serious consequences including failure to complete chemotherapy cycles, a higher risk of not proceeding to surgical resection and poorer overall survival. Efforts should be made to reduce toxicity and research should aim to identify responders and factors predictive of toxicity.

Loco-regional staging accuracy in oesophageal cancer-How good are we in the modern era?

INTRODUCTION: Accuracy of locoregional staging in patients with oesophageal cancer is critical in determining operability and the need for neoadjuvant treatment. Imaging technology has advanced significantly in recent years but it is not known whether this translates to improved staging accuracy. This study investigates staging accuracy in relation to CT, EUS, PET-CT and final pre-operative stage. It specifically addresses the accuracy of staging with respect to the threshold for administering neoadjuvant therapies. MATERIALS AND METHODS: Pre-operative staging according to CT, EUS, PET-CT and final pre-operative stage were compared to the postoperative histological staging in 133 patients undergoing potentially curative surgery (without neoadjuvant therapy) for oesophageal cancer between January 2010 and January 2015. T and N stage accuracies were reported separately for each imaging modality. Patients were also divided into two groups depending on whether the final pre-operative stage was below (≤T2, N0, early tumours) or above (≥T3 and/or ≥N1, locally advanced tumours) the threshold for offering neoadjuvant therapy. Accuracy of pre-operative staging was then analysed with respect to identification of patients below/above this threshold. The additional benefit offered by EUS for this purpose was investigated. RESULTS: T stage accuracies were 72.6%, 76.7% and 79.3% for CT, EUS and final pre-operative stage respectively. N stage accuracies were 75.6%, 77.2%, 74.5% and 78.6% for CT, EUS, PET-CT and final pre-operative stage respectively. Staging accuracy with respect to threshold for neoadjuvant treatment showed 62.0% early tumours were correctly staged and 80.5% advanced tumours were correctly staged. Whether or not patients underwent EUS did not affect the staging accuracy with respect to neoadjuvant treatment threshold. CONCLUSIONS: Staging accuracy with respect to the threshold for treatment with neoadjuvant therapy is poor, leading to potential over/under treatment. Predicting individual response to neoadjuvant therapy would provide a better way to determine which patients should receive this additional treatment.

A randomised trial of post-discharge enteral feeding following surgical resection of an upper gastrointestinal malignancy.

BACKGROUND: Patients undergoing upper gastrointestinal surgery often eat poorly post-operatively, despite dietetic input. A pilot study was conducted to examine the benefit of a 6 week nutritional supplementation via a feeding jejunostomy on fatigue, quality of life and independent living. METHODS: A feeding jejunostomy was placed routinely at oesophagectomy or total gastrectomy for cancer. At discharge, patients were randomised to nutritional supplementation (600 kcal/day) via their feeding jejunostomies or no jejunal supplement. Patients were assessed at discharge and 3, 6, 12 and 24 weeks following discharge for fatigue (MFI-20), quality of life (QLQ-OES18), health economic analysis (EQ5D) as well as completing a two-day dietary diary. RESULTS: 44 patients (M:F, 29:15) were randomised, 23 received jejunal supplements. There were no differences between the groups. Percentage of calculated energy requirement received was greater in the supplemented group at weeks 3 and 6 (p < 0.0001). Oral energy intake was not different between the groups at any time period. After hospital discharge, there were no differences in MFI-20, EQ5D and QLQ-OES18 scores at any time point. From hospital discharge fatigue improved and plateaued at 6 weeks (p < 0.05 for both groups), independence at 12 weeks (p < 0.05 for both groups). No improvement was seen in quality of life until 24 weeks in the active group alone (p < 0.02) and not at all in the control group. CONCLUSIONS: Addition of jejunal feeding is effective in providing patients with an adequate energy intake. Increased energy intake however, produced no obvious improvement in measures of fatigue, quality of life or health economics.

Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial.

BACKGROUND: Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6-9 months. Minimal-access surgery may accelerate recovery. OBJECTIVES: The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches. DESIGN: Pilot parallel three-arm randomised controlled trial nested within feasibility work. SETTING: Two UK NHS departments of upper gastrointestinal surgery. PARTICIPANTS: Patients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy. INTERVENTIONS: Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access. MAIN OUTCOME MEASURE: The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited. RESULTS: During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing, allowing a seamless transition into the definitive trial. Consequently, the database is unlocked at the time of writing and data presented here are for patients recruited by 31 August 2014. Random allocation achieved a good balance between the arms of the study, which, as a high proportion of patients underwent their allocated surgery (69/79, 87%), ensured a fair comparison between the interventions. Dressing patients with large bandages, covering all possible incisions, was successful in keeping patients blind while pain was assessed during the first week post surgery. Postsurgical length of stay and risk of adverse events were within the typical range for this group of patients, with one death occurring within 30 days among 76 patients. There were good completion rates for the assessment of pain at 6 days post surgery (88%) and of the patient-reported outcomes at 6 weeks post randomisation (74%). CONCLUSIONS: Rapid recruitment to the pilot trial and the successful refinement of methodology indicated the feasibility of a definitive trial comparing different approaches to oesophagectomy. Although we have shown a full trial of open compared with minimally invasive oesophagectomy to be feasible, this is necessarily based on our findings from the two clinical centres that we could include in this small preliminary study. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59036820. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 48. See the NIHR Journals Library website for further project information.

DiPALS: Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis - a randomised controlled trial.

BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease resulting in death, usually from respiratory failure, within 2-3 years of symptom onset. Non-invasive ventilation (NIV) is a treatment that when given to patients in respiratory failure leads to improved survival and quality of life. Diaphragm pacing (DP), using the NeuRx/4(®) diaphragm pacing system (DPS)™ (Synapse Biomedical, Oberlin, OH, USA), is a new technique that may offer additional or alternative benefits to patients with ALS who are in respiratory failure. OBJECTIVE: The Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis (DiPALS) trial evaluated the effect of DP on survival over the study duration in patients with ALS with respiratory failure. DESIGN: The DiPALS trial was a multicentre, parallel-group, open-label, randomised controlled trial incorporating health economic analyses and a qualitative longitudinal substudy. PARTICIPANTS: Eligible participants had a diagnosis of ALS (ALS laboratory-supported probable, clinically probable or clinically definite according to the World Federation of Neurology revised El Escorial criteria), had been stabilised on riluzole for 30 days, were aged ≥ 18 years and were in respiratory failure. We planned to recruit 108 patients from seven UK-based specialist ALS or respiratory centres. Allocation was performed using 1 : 1 non-deterministic minimisation. INTERVENTIONS: Participants were randomised to either standard care (NIV alone) or standard care (NIV) plus DP using the NeuRX/4 DPS. MAIN OUTCOME MEASURES: The primary outcome was overall survival, defined as the time from randomisation to death from any cause. Secondary outcomes were patient quality of life [assessed by European Quality of Life-5 Dimensions, three levels (EQ-5D-3L), Short Form questionnaire-36 items and Sleep Apnoea Quality of Life Index questionnaire]; carer quality of life (EQ-5D-3L and Caregiver Burden Inventory); cost-utility analysis and health-care resource use; tolerability and adverse events. Acceptability and attitudes to DP were assessed in a qualitative substudy. RESULTS: In total, 74 participants were randomised into the trial and analysed, 37 participants to NIV plus pacing and 37 to standard care, before the Data Monitoring and Ethics Committee advised initial suspension of recruitment (December 2013) and subsequent discontinuation of pacing (on safety grounds) in all patients (June 2014). Follow-up assessments continued until the planned end of the study in December 2014. The median survival (interquartile range) was 22.5 months (lower quartile 11.8 months; upper quartile not reached) in the NIV arm and 11.0 months (6.7 to 17.0 months) in the NIV plus pacing arm, with an adjusted hazard ratio of 2.27 (95% confidence interval 1.22 to 4.25; p = 0.01). CONCLUSIONS: Diaphragmatic pacing should not be used as a routine treatment for patients with ALS in respiratory failure. FUTURE WORK: It may be that certain population subgroups benefit from DP. We are unable to explain the mechanism behind the excess mortality in the pacing arm, something the small trial size cannot help address. Future research should investigate the mechanism by which harm or benefit occurs further. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53817913. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 45. See the HTA programme website for further project information. Additional funding was provided by the Motor Neurone Disease Association of England, Wales and Northern Ireland.

Less is more: a project to reduce the number of PIMs (potentially inappropriate medications) on an elderly care ward.

Potentially inappropriate prescribing in healthcare of the elderly (HCE) is associated with avoidable adverse drug events (ADEs).1(,)2 A recent set of prescribing criteria has been designed and validated, called "Screening Tool of Older Persons' Prescriptions" (STOPP), to rationalise prescribing in hospitalised patients on HCE wards.1(,)3 The aim of this quality improvement project was to identify how many potentially inappropriate medications (PIMs) were prescribed on these wards, and remove them. This was executed by implementing a ward round checklist, which incorporated STOPP criteria, for the twice weekly, consultant led ward rounds. This quality improvement project was carried out over four months. In a pilot study, we identified eight inappropriate medical prescriptions among 148 medications (5.4% ) prescribed on one ward. After applying a checklist for a structured ward round, we reviewed the medications prescribed on that ward, and found 10 PIMs out of 192 (5.2% ). Utilising the increasingly recognised "plan, do, study, act" (PDSA) cycle,4 we implemented departmental teaching and meetings with other members of the multidisciplinary team, which raised awareness of PIMs among junior doctors, as well as involving our pharmacists in drug chart screening. During this process we continued with a further six cycles on a bi-weekly basis, and saw a gradual decrease in PIM to 1.5%. In conclusion, a structured ward round, facilitated by a checklist that included review of drug charts based on STOPP criteria, demonstrated a considerable reduction of PIMs. It would be interesting to apply this quality improvement project to non-HCE wards, including general surgical wards or adult psychiatry wards, as a means of not only reducing the effects of ADEs, but also the expenditure associated with unnecessary drug prescriptions, and the costs associated with additional care arising from associated ADEs.

Positron emission tomography-computed tomography in oesophageal cancer staging: a tailored approach.

BACKGROUND: Positron emission tomography-computed tomography (PET-CT) scanning is used routinely in the staging of oesophageal cancer to identify occult metastases not apparent on CT and changes the management in typically 3-18% patients. The authors aim to re-evaluate its role in the management of oesophageal cancer, investigating whether it is possible to identify a group of patients that will not benefit and can safely be spared from this investigation. METHODS: Consecutive patients with oesophageal cancer undergoing PET-CT staging between 2010 and 2013 were identified from a specialist modern multidisciplinary team database. Without knowledge of the PET-CT result, patients were stratified into low-risk or high-risk groups according to the likelihood of identifying metastatic disease on PET-CT based on specified criteria routinely available from endoscopy and CT reports. Clinical outcomes in the two groups were investigated. RESULTS: In 383 undergoing PET-CT, metastatic disease was identified in 52 (13.6%) patients. Eighty-three patients were stratified as low risk and 300 as high risk. None of the low-risk patients went on to have metastatic disease identified on PET-CT. Of the high-risk patients, 17% had metastatic disease identified on PET-CT. CONCLUSIONS: In one of the largest studies to date investigating the influence of staging PET-CT on management of patients with oesophageal cancer, the authors report a classification based on endoscopy/CT criteria is able to accurately stratify patients according to the risk of having metastatic disease. This could be used to avoid unnecessary PET-CT 22% of patients, saving cost, inconvenience and reducing potential delay to definitive treatment in this group.

The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer--the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial.

BACKGROUND: There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. METHODS/DESIGN: A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. DISCUSSION: The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. TRIAL REGISTRATION: The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol.

Surgical time out checklist with debriefing and multidisciplinary feedback improves venous thromboembolism prophylaxis in thoracic surgery: a prospective audit.

OBJECTIVES: There is a significant global burden of preventable morbidity and mortality after surgery caused by avoidable adverse events. Venous thromboembolism (VTE) prophylaxis, despite evidence for its efficacy, is not reliably and consistently prescribed, and is currently a serious concern for patient safety. The aim of this study was to prospectively audit errors captured by an extended surgical time out checklist and relate them to the introduction of a safety culture. METHODS: The use of an extended surgical time out checklist was prospectively audited, in consecutive patients in one operating theatre over a period of two years. Errors captured were analysed and related to other improvements to safety culture; human factors training, debriefing and regular departmental meetings. RESULTS: Time out was performed in 959 patients of 990 (96.8%) undergoing thoracic surgery. Performance was consistent over time. Errors were categorized as VTE prophylaxis (n = 53, 6%), blood products (n = 11), clerical (n = 5), imaging (n = 2) and miscellaneous (n = 2). After a lag period of 15 months, during which the team underwent human factors training, introduced debriefing and escalated VTE prophylaxis to regular departmental meetings, VTE prophylaxis errors were substantially reduced. The temporal relationship between error capture and error elimination is explored. CONCLUSIONS: Use of checklists alongside appropriate human factors training, debriefing and regular multidisciplinary communication can substantially improve VTE prophylaxis in patients undergoing surgery.

Video-assisted approach combined with the open Brompton technique for intracavitary drainage of giant bullae.

The modified Monaldi procedure represents a nonexcisional treatment option for patients with giant bullous emphysema as an alternative to bullectomy. We want to highlight its role in the surgical treatment of emphysema and discuss changes made to the open-access Brompton approach through introduction of video-assisted thoracic surgical technique.