Diaphragmatic dysfunction is associated with postoperative pulmonary complications and phrenic nerve paresis in patients undergoing thoracic surgery.

PURPOSE: We aimed to quantify perioperative changes in diaphragmatic function and phrenic nerve conduction in patients undergoing routine thoracic surgery. METHODS: A prospective observational study was performed in patients undergoing esophageal resection or pulmonary lobectomy. Examinations were carried out the day prior to surgery, 3 days and 10-14 days after surgery. Endpoints for diaphragmatic function included ultrasonographic measurements of diaphragmatic excursion and thickening fraction. Endpoints for phrenic nerve conduction included baseline-to-peak amplitude, peak-to-peak amplitude, and transmission delay. Measurements were assessed on both the surgical side and the non-surgical side of the thorax. RESULTS: Forty patients were included in the study. Significant reductions in diaphragmatic excursion were seen on the surgical side of the thorax for all excursion measures (posterior part of the right hemidiaphragm, p < 0.001; hemidiaphragmatic top point, p < 0.001; change in intrathoracic area, p < 0.001). Significant changes were seen for all phrenic nerve measures (baseline-to-peak amplitude, p < 0.001; peak-to-peak amplitude, p < 0.001; transmission delay, p = 0.041) on the surgical side. However, significant changes were also seen on the non-surgical side for all phrenic nerve measures (baseline-to-peak amplitude, p < 0.001; peak-to-peak amplitude, p < 0.001; transmission delay, p = 0.022). A postoperative reduction in posterior diaphragmatic excursion of more than 50% was significantly associated with postoperative pulmonary complications (coefficient: 2.69 (95% CI [1.38, 4.01], p < 0.001). CONCLUSION: Thoracic surgery caused a significant unilateral reduction in diaphragmatic excursion on the surgical side of the thorax, which was accompanied by significant changes in phrenic nerve conduction. However, phrenic nerve conduction was also significantly affected on the non-surgical side to a lesser extent, which was not mirrored in diaphragmatic excursion. Our findings suggest that phrenic nerve paresis plays a role in postoperative diaphragmatic dysfunction, which may be a contributing factor in the pathogenesis of postoperative pulmonary complications. CLINICAL TRIALS REGISTRATION NUMBER: NCT04507594.

Efficacy of avoiding chest drains after video-assisted thoracoscopic surgery wedge resection: protocol for a randomised controlled trial.

INTRODUCTION: The use of routine postoperative chest drains after video-assisted thoracoscopic surgery (VATS) of the lung is a practice based on tradition with the aim of draining fluid and air. However, new evidence suggests that chest drains can be avoided in selected cases. With this randomised controlled trial, we wish to establish the efficacy and safety of avoiding postoperative chest drains compared with routine postoperative chest drains. METHODS AND ANALYSIS: This is a two-centre randomised controlled trial without allocation concealment, but where randomisation occurs after the end of procedure leaving operative personnel blinded during surgery. The sample size is calculated to show a difference in pain measurements using the Numeric Rating Scale under different circumstances and at different time points to show superiority of the intervention. The trial is pragmatic by design to reflect the daily clinical scenario and with the aim of increasing the external validity of the results. ETHICS AND DISSEMINATION: Approval by the local ethics committees has been obtained for both sites. The study was registered with ClinicalTrials.gov (NCT05358158) prior to inclusion. The results of the trial will be disseminated by publication in an international journal and presentation at major international thoracic surgical meetings. ARTICLE SUMMARY: This is a randomised controlled trial estimating the effects of avoiding a chest drain after VATS wedge resection of the lung on pain, total morphine use, quality of life and complications. TRIAL REGISTRATION NUMBER: NCT05358158.

Comparison of video assisted thoracoscopic surgery and thoracotomy for treatment of pleural infection stage II and III: a literature review.

Background and Objective: Pleural infection is associated with significant mortality and morbidity worldwide, with a steadily increasing incidence. We sought to investigate whether video-assisted thoracic surgery (VATS) or thoracotomy provides the best outcomes in the treatment of stage II and III pleural infection as indications remain controversial. Methods: Systematic review of relevant articles from the PubMed database. Key Content and Findings: Nine non-randomized retrospective studies published between 1996 and 2020 with a total of 2,121 patients were included. Results varied between studies, but overall shorter operative and recovery times and greater patient satisfaction were demonstrated using VATS compared with thoracotomy. Conclusions: Although VATS and thoracotomy are viable treatment options for stage II and III pleural infection, VATS has potential advantages in terms of decreased operation time, fewer days with tube drainage, shorter postoperative hospital stay, reduced postoperative pain, increased patient satisfaction with the procedure, and wound appearance. VATS has limitations in the treatment of patients with stage III pleural infection, where delayed surgical referral has been shown to increase the risk of intraoperative conversion to thoracotomy. The data to date implies that debridement by VATS should be proposed as soon as possible in stage II pleural infection and considered in cases of stage III pleural infection.

Safe and efficient 2-step implementation of totally minimally invasive esophagectomy.

Background: The clinical benefits of totally minimal invasive esophagectomy (TIME) compared to open esophagectomy are documented and include reduced morbidity like pulmonary infections, shorter hospital stay and an increase in short-term quality of life. However, transition to TIME can be associated with a learning curve associated increased morbidity. We report our implementation of TIME using a 2-step approach, where the thoracoscopic part was added to the laparoscopic part in carefully selected patients. The hypothesis was that the 2-step implementation provides a safe and efficient implementation without compromising the outcomes for the patients. The aim of this study was to evaluation the implementation of minimal invasive esophagectomy at Aarhus University Hospital, where a 2-step implementation strategy has been used. Methods: In this retrospective observational cohort study a total of 369 patients with esophagus or gastroesophageal cancers underwent esophagectomy from September 1st, 2016 to July 31st, 2021 in a single high-volume tertiary institution. Totally minimally invasive Ivor Lewis esophagectomy was performed by experienced minimal invasive surgeons in 120 of the cases. The study presents the complication rates of the TIME patients in the implementation phase. Results: Anastomotic leakage occurred in 7.5% of the cases and pneumonia occurred in 5.8% of the cases. The lymph node count reached 16 or more in 94.3% of the cases and R0-resection was performed in 98.3% of the cases. Textbook outcome for esophageal cancer surgery was achieved in 45.8% of the patients. Conclusions: Hybrid minimal invasive esophagectomy can serve as a step towards totally minimally invasive esophagectomy. In our institution, major learning curve associated complications was avoided and a high level of cancer control was achieved by a 2-step implementation strategy in carefully selected patients.

Endobronchial valve treatment in chronic obstructive pulmonary disease: A qualitative study of patients' expectations.

Objectives: Endobronchial valve (EBV) treatment is a treatment option for selected patients with severe chronic obstructive pulmonary disease (COPD) to reduce dyspnea and improve quality of life. However, the procedure is associated with risk of complications, and not all patients achieve the expected outcomes. The present study explores patients' expectations while waiting for EBV treatment. Methods: Fifteen patients accepted for EBV treatment at Aarhus University Hospital in Denmark from October 2020 to June 2021 participated in a 30-min, semi-structured interview about (1) the experience of living with COPD and (2) expectations regarding EBV. Results: Four themes were identified: a life of reduced quality; hopes and expectations; information about EBV; and perception of risks. Most patients described their lives as not worth living, and they hoped that EBV would give them their physical and social lives back, while also being aware that EBV would probably not work miracles. Patients' information seeking was influenced by their hopes and expectations to the treatment. They filtered out negative information, focusing on the hope for a positive outcome. This made them willing to run the risk of complications. Conclusion: Living a life of considerably reduced quality, patients might have an increased focus on potential positive effects of EBV treatment while filtering out information about potential side effects. This might bias their decision-making process.

Does the time to diagnosis and treatment influence outcome in adults with pleural infections.

Objective: To investigate the effect of early diagnosis and intervention in adult patients with complicated parapneumonic pleural effusion or pleural empyema and the impact on outcomes. Methods: A systematic review based on a literature search of the PubMed database was performed. Results: Eleven eligible studies were included; nine observational studies and two randomised controlled trials totalling a study population of 10,717 patients. The studies were conducted from 1992 to 2018, all in Europe and Northern America except one. Results varied between studies, but a trend towards better outcome in patients with shorter duration of symptoms and quicker initiation of treatment was found. We found that duration of symptoms before treatment may affect length of hospital stay, rate of conversion to open surgery, and frequency of complications. Conclusion: We found that an earlier intervention in adults suffering from complicated parapneumonic pleural effusion and pleural empyema may potentially improve the outcome of patients in terms of length of stay, conversion to open surgery, and general complications following treatment, but not regarding mortality. Further studies are required to specify the timing of each intervention, and direct comparison in early management of interventions.

Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial - surgery as first-line treatment.

INTRODUCTION: Pleural empyema is a frequent disease with a high morbidity and mortality. Current standard treatment includes antibiotics and thoracic ultrasound (TUS)-guided pigtail drainage. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of video-assisted thoracoscopic surgery (VATS) as first-line treatment. The aim of this study is to determine the difference in outcome in patients diagnosed with complex parapneumonic effusion (stage II) and pleural empyema (stage III) who are treated with either VATS surgery or TUS-guided drainage and intrapleural therapy (fibrinolytic (Alteplase) with DNase (Pulmozyme)) as first-line treatment. METHODS AND ANALYSIS: A national, multicentre randomised, controlled study. Totally, 184 patients with a newly diagnosed community acquired complicated parapneumonic effusion or pleural empyema are randomised to either (1) VATS procedure with drainage or (2) TUS-guided pigtail catheter placement and intrapleural therapy with Actilyse and DNase. The total follow-up period is 12 months. The primary endpoint is length of hospital stay and secondary endpoints include for example, mortality, need for additional interventions, consumption of analgesia and quality of life. ETHICS AND DISSEMINATION: All patients provide informed consent before randomisation. The research project is carried out in accordance with the Helsinki II Declaration, European regulations and Good Clinical Practice Guidelines. The Scientific Ethics Committees for Denmark and the Danish Data Protection Agency have provided permission. Information about the subjects is protected under the Personal Data Processing Act and the Health Act. The trial is registered at www. CLINICALTRIALS: gov, and monitored by the regional Good clinical practice monitoring unit. The results of this study will be published in peer-reviewed journals and presented at various national and international conferences. TRIAL REGISTRATION NUMBER: NCT04095676.

Development of and Gathering Validity Evidence for a Theoretical Test in Thoracic Ultrasound.

BACKGROUND: Thoracic ultrasound (TUS) has a high diagnostic accuracy for many common pulmonary diseases, but theoretic knowledge in sonographic physics, thoracic anatomy and physiology, and sonopathologic patterns is required to develop competence. OBJECTIVES: The aims of the study were to develop and gather validity evidence for a theoretical test in TUS and to establish a pass/fail standard. METHODS: Content was provided based on expert interviews, leading to the creation of 113 initial multiple-choice question (MCQ) items. Consensus was reached on 92 proceeding items through a Delphi process, and items were presented to physicians with different knowledge and experience in TUS. Answers were used for item statistics in order to select the items with the most optimal item discrimination and difficulty (i.e., level I items) to be included in the final test. Mean scores of the novice, intermediate and experienced groups were compared, and a pass/fail score was established using the contrasting groups' standard setting method. RESULTS: Item statistics revealed 38 level I items, of which 30 were selected to be included in the final test. The internal consistency was high (Cronbach's alpha = 0.88). Differences in mean scores were 8.6 points (p < 0.001), 6.3 points (p = 0.01), and 14.9 points (p < 0.001) between novices and intermediates, intermediates and experienced, and novices and experienced, respectively. A pass/fail standard of 20 points was established. CONCLUSION: The established MCQ test can distinguish between physicians with different levels of competence in TUS and enables an objective, evidence-based approach for assessing the theoretical knowledge of trainees undergoing an educational programme in TUS.

Cost-utility analysis of minimally invasive surgery for lung cancer: a randomized controlled trial.

OBJECTIVES: Minimally invasive video-assisted thoracic surgery (VATS) was first introduced in the early 1990s. For decades, numerous non-randomized studies demonstrated advantages of VATS over thoracotomy with lower morbidity and shorter hospital stay, but only recently did a randomized trial document that VATS results in lower pain scores and better quality of life. Opposing arguments for VATS have always been increased costs and concerns about oncological adequacy. In this paper, we aim to investigate the cost-effectiveness of VATS. METHODS: The study was designed as a cost-utility analysis of the first 12 months following surgery and was performed together with a clinical randomized controlled trial of VATS versus thoracotomy for lobectomy of stage 1 lung cancer during a 6-year period (2008-2014). All health-related expenses were retrieved from a national database (Statistics Denmark) including hospital readmissions, outpatient clinic visits, prescription medication costs, consultations with general practitioners, specialists, physiotherapists, psychologists and chiropractors. RESULTS: One hundred and three VATS patients and 103 thoracotomy patients were randomized. Mean costs per patient operated by VATS were 103 108 Danish Kroner (Dkr) (€13 818) and 134 945 Dkr (€18 085) by thoracotomy, making the costs for VATS 31 837 Dkr (€4267) lower than thoracotomy (P < 0.001). The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021 (P = 0.048, 95% confidence interval -0.04 to -0.00015) in favour of VATS. The median duration of the surgical procedure was shorter after thoracotomy (79 vs 100 min; P < 0.001). The mean length of hospitalization was shorter following VATS (4.8 vs 6.7 days; P = 0.027). The use of other resources was not significantly different between groups. The costs of resources were lower in the VATS group. This difference was primarily due to reduced costs of readmissions (VATS 29 247 Dkr vs thoracotomy 51 734 Dkr; P < 0.001) and costs of outpatient visits (VATS 51 412 Dkr vs thoracotomy 61 575 Dkr; P = 0.012). CONCLUSIONS: VATS is a cost-effective alternative to thoracotomy following lobectomy for stage 1 lung cancer. Economical outcomes as measured by quality-adjusted life years were significantly better and overall costs were lower for VATS. CLINICAL TRIAL REGISTRATION NUMBER: NCT01278888.

Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial.

BACKGROUND: Video-assisted thoracoscopic surgery (VATS) is used increasingly as an alternative to thoracotomy for lobectomy in the treatment of early-stage non-small-cell lung cancer, but remains controversial and worldwide adoption rates are low. Non-randomised studies have suggested that VATS reduces postoperative morbidity, but there is little high-quality evidence to show its superiority over open surgery. We aimed to investigate postoperative pain and quality of life in a randomised trial of patients with early-stage non-small-cell lung cancer undergoing VATS versus open surgery. METHODS: We did a randomised controlled patient and observer blinded trial at a public university-based cardiothoracic surgery department in Denmark. We enrolled patients who were scheduled for lobectomy for stage I non-small-cell lung cancer. By use of a web-based randomisation system, we assigned patients (1:1) to lobectomy via four-port VATS or anterolateral thoracotomy. After surgery, we applied identical surgical dressings to ensure masking of patients and staff. Postoperative pain was measured with a numeric rating scale (NRS) six times per day during hospital stay and once at 2, 4, 8, 12, 26, and 52 weeks, and self-reported quality of life was assessed with the EuroQol 5 Dimensions (EQ5D) and the European Organisation for Research and Treatment of Cancer (EORTC) 30 item Quality of Life Questionnaire (QLQ-C30) during hospital stay and 2, 4, 8, 12, 26, and 52 weeks after discharge. The primary outcomes were the proportion of patients with clinically relevant moderate-to-severe pain (NRS ≥3) and mean quality of life scores. These outcomes were assessed longitudinally by logistic regression across all timepoints. Data for the primary analysis were analysed by modified intention to treat (ie, all randomised patients with pathologically confirmed non-small-cell lung cancer). This trial is registered with ClinicalTrials.gov, number NCT01278888. FINDINGS: Between Oct 1, 2008, and Aug 20, 2014, we screened 772 patients, of whom 361 were eligible for inclusion and 206 were enrolled. We randomly assigned 103 patients to VATS and 103 to anterolateral thoracotomy. 102 patients in the VATS group and 99 in the thoracotomy group were included in the final analysis. The proportion of patients with clinically relevant pain (NRS ≥3) was significantly lower during the first 24 h after VATS than after anterolateral thoracotomy (VATS 38%, 95% CI 0·28-0·48 vs thoracotomy 63%, 95% CI 0·52-0·72, p=0·0012). During 52 weeks of follow-up, episodes of moderate-to-severe pain were significantly less frequent after VATS than after anterolateral thoracotomy (p<0·0001) and self-reported quality of life according to EQ5D was significantly better after VATS (p=0·014). By contrast, for the whole study period, quality of life according to QLQ-C30 was not significantly different between groups (p=0·13). Postoperative surgical complications (grade 3-4 adverse events) were similar between the two groups, consisting of prolonged air leakage over 4 days (14 patients in the VATS group vs nine patients in the thoracotomy group), re-operation for bleeding (two vs none), twisted middle lobe (one vs three) or prolonged air leakage over 7 days (five vs six), arrhythmia (one vs one), or neurological events (one vs two). Nine (4%) patients died during the follow-up period (three in the VATS group and six in the thoracotomy group). INTERPRETATION: VATS is associated with less postoperative pain and better quality of life than is anterolateral thoracotomy for the first year after surgery, suggesting that VATS should be the preferred surgical approach for lobectomy in stage I non-small-cell lung cancer. FUNDING: Simon Fougner Hartmanns Familiefond, Guldsmed AL & D Rasmussens Mindefond, Karen S Jensens legat, The University of Southern Denmark, The Research Council at Odense University Hospital, and Department of Cardiothoracic Surgery, Odense University Hospital.

[Treatment outcomes for patients with papilla of Vater cancer]. / Behandlingsresultater hos patienter med cancer i papilla Vateri.

INTRODUCTION: Cancer of the papilla of Vater is a relatively rare disease. It is difficult to separate from other periampullary tumours at the time of diagnosis. Recent studies have shown that patients with cancer of the papilla tend survive longer than patients with pancreatic cancer and cancers of biliary and duodenal origin. The aim of this study was to compare our results with those reported in the international literature. MATERIAL AND METHODS: The study included all patients who were referred with cancer of the papilla to the Department of Surgical Gastroenterology, Odense University Hospital, between 1995 and 2005. The data were collected retrospectively from hospital and departmental databases. RESULTS: Among the 35 patients, 30 underwent operation. A total of 27 had a Whipple resection performed, 26 of whom were radical resections. Three patients had a palliative gastroenteroanastomosis performed. Postoperative mortality was 7%, and the 1, 3 and 5-year survival was 74%, 59% and 43%, respectively. Resected patients without lymph node involvement had an estimated 5-year survival of 58%. CONCLUSION: The estimated 5-year survival of over 40% in resected patients was comparable with that reported in international studies. We found a significantly higher 5-year survival in patients without lymph node involvement, and the general prognosis for patients with cancer of the papilla was better than the prognosis reported for other periampullary tumours.

[Evaluation of curative and palliative treatment of duodenal adenocarcinoma]. / Resultaterne efter kurativ og palliativ behandling af duodenale adenokarcinomer.

INTRODUCTION: Primary adenocarcinoma of the duodenum is a rare disease in this part of the world, and data on survival following curative and palliative treatment are scarce. MATERIAL AND METHODS: All patients treated for duodenal cancer (DC) at the Department of Surgery, Odense University Hospital, between January 1995 and February 2006 were retrospectively evaluated. Tumours arising from the pancreatic head, the papilla of Vater, distal bile duct or tumour infiltration from surrounding organs (apart from the duodenum) were excluded. RESULTS: Eleven (31%) of the 35 included patients (17 women and 18 men, median age 62 years, range 45-88 years) received a curative resection (R0 resection), while 24 patients had surgical or endoscopic palliation. Survival following R0 resection was significantly higher than survival in the palliative group (p = 0.0002). The median survival was 45 months (confidence interval (CI) 6- ) in the R0 group versus 5.3 months (CI 2-11) in the palliative group. CONCLUSION: In a consecutive, but retrospective DC population, we found that only one third of the patients were candidates for a curative resection, and despite microscopical, radical surgery only one third were alive after five years.