Camrelizumab, chemotherapy and apatinib in the neoadjuvant treatment of resectable oesophageal squamous cell carcinoma: a single-arm phase 2 trial.

Background: In resectable oesophageal squamous cell carcinoma (ESCC), the efficacy of camrelizumab combined with chemotherapy and apatinib followed by minimally invasive oesophagectomy is not clear. We aimed to fill this knowledge gap. Methods: This investigator-initiated, single-arm, prospective, phase 2 trial was performed at the Second Affiliated Hospital of Zhejiang University, China. Patients (aged 18-75 years) who were histologically or cytologically diagnosed with ESCC were deemed suitable to participate in this trial. Patients received 2-3 cycles of neoadjuvant therapy with camrelizumab, nedaplatin, albumin paclitaxel, and apatinib; each cycle was repeated every 14 days. Surgery occurred 4-6 weeks after the last neoadjuvant treatment cycle. The primary outcome was the pathological complete response (PCR) rate of the tumour and lymph nodes. The changes in the peripheral blood immunoprofile among patients without PCR (ie, non-PCR [NPCR]) and with PCR were assessed by mass cytometry. This study was registered with ClinicalTrials.gov, NCT04666090. Findings: 42 patients were enrolled between November 23, 2020 and December 31, 2022. The disease control rate was 100.0% (95% CI, 91.6-100%), and the objective response rate was 83.3% (95% CI, 68.6-93.0%). Six (14.3%) patients experienced grade 3 adverse events. The most common were white blood cell count decrease (31.0%), alopecia (81.0%), asthenia (38.1%), and reactive cutaneous capillary endothelial proliferation (35.7%). 41 patients received minimally invasive oesophagectomy; all 41patients achieved R0 resection, and 18 (43.9%, 95% CI, 28.5-60.3%) patients achieved PCR. The median follow-up was 23 months and the 2-year survival rate was 85.9%. T-cell subsets in both the PCR and NPCR groups exhibited consistency in response to neoadjuvant therapy. In contrast, some of natural killer (NK) cells (NK-C03, NK-C11), B cells (B-C06) and monocytes (M-C05), exhibited significant differences between the PCR and NPCR groups before neoadjuvant therapy. M-C06 had a significant difference in the PCR group and NPCR group after neoadjuvant therapy. NK-C12 and B-C15 showed significant differences both before and after neoadjuvant therapy. Interpretation: The application of camrelizumab, chemotherapy and apatinib in the neoadjuvant setting for locally advanced ESCC has shown promising antitumour activity and an acceptable safety profile in this single-arm study. In the neoadjuvant setting, NK cell, B cell, and monocyte subsets exhibited greater predictive power for immunotherapy responsiveness than T-cell subsets. Longer follow-up to assess survival outcomes and a phase 3 randomised trial are needed to further evaluate the proposed treatment. Funding: The China Anti-Cancer Association and the "Leading Goose" Research and Development Project of Zhejiang Province.

Minimally invasive surgery for gastro-oesophageal junction adenocarcinoma: Current evidence and future perspectives.

Minimally invasive surgery is increasingly indicated in the management of malignant disease. Although oesophagectomy is a difficult operation, with a long learning curve, there is actually a shift towards the laparoscopic/thoracoscopic/ robotic approach, due to the advantages of visualization, surgeon comfort (robotic surgery) and the possibility of the whole team to see the operation as well as and the operating surgeon. Although currently there are still many controversial topics, about the surgical treatment of patients with gastro-oesophageal junction (GOJ) adenocarcinoma, such as the type of open or minimally invasive surgical approach, the type of oesophago-gastric resection, the type of lymph node dissection and others, the minimally invasive approach has proven to be a way to reduce postoperative complications of resection, especially by decreasing pulmonary complications. The implementation of new technologies allowed the widening of the range of indications for this type of surgical approach. The short-term and long-term results, as well as the benefits for the patient - reduced surgical trauma, quick and easy recovery - offer this type of surgical treatment the premises for future development. This article reviews the updates and perspectives on the minimally invasive approach for GOJ adenocarcinoma.

The efficacy and feasibility of neoadjuvant immunotherapy plus chemotherapy followed by McKeown minimally invasive oesophagectomy for locally advanced oesophageal squamous cell carcinoma.

Introduction: In immunotherapy, antibodies are activated to block immune checkpoints, resist tumour immunosuppression, shrink tumours and prevent a recurrence. As the science behind tumour immunotherapy continuously develops and improves, neoadjuvant immunotherapy bears more prominent advantages: antigen exposure not only enhances the degree of tumour-specific T-cell response but also prolongs the duration of actions. In this study, we evaluated the efficacy and safety of McKeown minimally invasive oesophagectomy (McKeown MIO) following neoadjuvant immunotherapy combined with chemotherapy (NICT) in patients with locally advanced oesophageal cancer (OC). Patients and Methods: In this retrospective study, 94 patients underwent either NICT or neoadjuvant chemotherapy (NCT) followed by MIO at our institution from January 2020 to October 2022. We assessed the therapy-related adverse events and perioperative outcomes and compared them between the two groups. Results: After completing at least two cycles of neoadjuvant therapy, all patients underwent McKeown MIO with negative margins within 4-7 weeks. Demographic data of the two cohorts were similar. Regarding perioperative characteristics, the median intraoperative blood loss was 50 ml in the NICT group, lower than that of the NCT group (100 ml, P < 0.05). In addition, the NICT group had significantly more harvested lymph nodes than the NCT group (P < 0.05). No significant differences were found in post-operative complications. The rate of objective response rate in the NICT group was higher than that in the NCT group (88.3% vs. 58.8%). Regarding tumour regression, the number of patients with TRG Grades 1-3 in the NICT group was more than that in the NCT. Adverse events experienced by the two groups included anaemia and elevated transaminase. We found no difference in the adverse events between the two groups. Conclusions: This study showed the efficacy and feasibility of NICT followed by McKeown MIO in treating locally advanced OC.

A rare cause of tracheopleural fistula following minimally invasive oesophagectomy.

Totally minimally invasive oesophagectomy (TMIE) has been utilised to reduce respiratory and cardiac complications, offering favourable clinical and oncological outcomes. A 62-year-old male patient underwent two-stage TMIE for a Siewert type I tumour. During thoracoscopic oesophageal mobilisation and lymphadenectomy, a 10-mm bone-like mass was recognised and dissected along the subcarinal nodes, revealing a 2-3mm opening on the inferomedial aspect of the right main bronchus. The airway opening was repaired after conversion. This is the first report of an accessory cardiac bronchus encountered during oesophagectomy. Recognition of its characteristic position and features may result in early diagnosis and avoidance of a potentially lethal injury.

Robot-assisted versus thoracolaparoscopic oesophagectomy for locally advanced oesophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy.

INTRODUCTION: Robot-assisted oesophagectomy (RAE) and thoracolaparoscopic oesophagectomy (TLE) are surgical techniques for the treatment of oesophageal cancer. This study aimed to compare the perioperative and mid-term outcomes of RAE versus TLE for patients with locally advanced oesophageal squamous cell carcinoma (ESCC) undergoing neoadjuvant chemoradiotherapy (nCRT). METHODS: Consecutive patients receiving nCRT plus RAE or TLE were retrospectively included in this single-institution study from January 2016 to January 2021. Perioperative outcomes were compared and survival analysis was performed. RESULTS: This study enrolled 251 patients, 80 (31.9%) in RAE and 171 (68.1%) in TLE. The conversion rate was equivalent in RAE versus TLE (3.8% vs 2.9%, P = 1). Median operative time in RAE was significantly shorter than that in TLE (254 vs 289 min, P < 0.001). Compared to TLE, RAE harvested more lymph nodes along the recurrent laryngeal nerve [4 (3-6) vs 3 (1-5), P < 0.001]. Overall complications were similar in RAE compared to TLE (38.8% vs 38.0%, P = 0.911). No statistically significant difference in disease-free survival (log-rank P = 0.721) or overall survival (log-rank P = 0.325) was found between groups. CONCLUSIONS: Compared to TLE, RAE could achieve shorter operative duration and better lymph nodes dissection along the bilateral RLN for locally advanced ESCC after nCRT, with comparable short-term outcomes. A long-term survival remains to be verified.

A 25 mm Circular Stapler Anastomosis Is Associated with Higher Anastomotic Leakage Rates Following Minimally Invasive Ivor Lewis Operation.

(1) Background: Minimally invasive oesophagectomy (MIE) with intrathoracic anastomosis is increasingly used in treating patients with oesophageal cancer. Anastomotic leakage (AL) remains a critical perioperative complication, despite recent advances in surgical techniques. It remains unclear to what extent the size of the circular stapler (CS), a 25 mm CS or a bigger CS, may affect the incidence of AL. This study aimed to evaluate whether the CS size in oesophagogastrostomy affects the postoperative AL rates and related morbidity in MIE. (2) Methods: We conducted a retrospective review of consecutive patients who had undergone thoracic MIE between August 2014 and July 2019 using a CS oesophagogastric anastomosis at the level of the Vena azygos. The patients were grouped according to CS size (mm): small-sized (SS25) and large-sized (LS29). The patient demographics, data regarding morbidity, and clinical outcomes were compared. The primary outcome measure was the AL rate related to the stapler size. (3) Results: A total of 119 patients were included (SS25: n = 65; LS29: n = 54). Except for the distribution of squamous cell carcinoma, the demographics were similar in each group. The AL rate was 3.7% in the LS29 group and 18.5% in the SS25 group (p = 0.01). The major morbidity (CD ≥ 3a) was significantly more frequent in the SS25 group compared with the LS29 group (p = 0.02). CS size, pulmonary complications, and cardiovascular disease were independent risk factors for AL in the multivariate analysis. (4) Conclusions: A 29 mm CS is associated with significantly improved surgical outcomes following standard MIE at the level of the azygos vein and should be conducted whenever technically feasible.

Feasibility, safety and oncological outcomes of minimally invasive oesophagectomy following neoadjuvant chemoradiotherapy for oesophageal squamous cell carcinoma - Experience from a tertiary care centre.

Background: Neoadjuvant chemoradiotherapy (nCRT) has improved the resectability and survival of operable oesophageal squamous cell carcinoma (OSCC). We aimed to study if nCRT for OSCC makes minimally invasive oesophagectomy (MIO) technically more challenging and if the peri-operative and oncological outcomes are acceptable for MIO following nCRT. Materials and Methods: A retrospective review of patients with OSCC (cT1-2N1-2, cT3-4aN0-2) treated with nCRT and MIO between 2013 and 2019 was performed. The operative details including the technical difficulty in tumour dissection and lymphadenectomy, the post-operative complications and oncological outcomes were studied. Results: Seventy-five patients (male:female - 50:25; mean [range] age - 55.49 ± 8.43 [22-72] years; stage II - 34.7%; stage III - 37.3%; stage IVA - 28.0%) were enrolled. The concurrent chemotherapy course was completed by 25.3% of patients and the most common reason limiting the completion of chemotherapy was neutropaenia (66.0%). A thoraco-laparoscopic (n = 60) or hybrid (n = 15) McKeown's oesophagectomy with a two-field lymphadenectomy was performed. The increased surgical difficulty was reported in 41 (54.7%) patients, particularly for mid-thoracic tumours and tumours exhibiting incomplete response. The 30-day overall and major complication rate was 48.0% and 20.0%, respectively, and there was no mortality. The rate of R0 resection, pathological complete response and median lymph nodal yield were 93.3%, 48% and 8 (range: 1-25), respectively. The mean overall survival (OS) was 62.2 months (95% confidence interval [CI]: 52.6-71.8) and recurrence-free survival (RFS) was 53.5 months (95% CI: 43.5-63.5). The 1-, 2- and 3-year OS and RFS were 89.5%, 78.8% and 64.4% and 71.1%, 61.3% and 56.6%, respectively. Conclusion: Minimally invasive McKeown's oesophagectomy is feasible and safe in patients with OSCC receiving nCRT. The radiation component of nCRT increases the degree of operative difficulty, especially in relation to the supracarinal dissection and lymphadenectomy. However, this drawback did not adversely affect the short-term surgical or the long-term oncological outcomes.

Short- and Long-Term Outcomes of Totally Versus Hybrid Minimally Invasive Ivor Lewis Oesophagectomy for Oesophageal Cancer: A Propensity Score-Matched Analysis.

Background: Few objective studies have compared totally minimally invasive Ivor Lewis oesophagectomy with hybrid procedure. Here we investigated whether the choice between totally and hybrid minimally invasive Ivor Lewis oesophagectomy influenced short-term outcomes and long-term patient survival. Methods: Patients who underwent totally or hybrid minimally invasive Ivor Lewis oesophagectomy between January 2014 and December 2017 were propensity score matched in a 1:1 ratio. The short- and long-term outcomes between the two groups were compared before and after matching. Results: Of 138 totally and 156 hybrid minimally invasive oesophagectomy patients were eligible, 104 patients from each group were propensity score matched. Totally minimally invasive oesophagectomy was associated significantly with less blood loss (median(IQR) 100(60-150) vs 120(120-200) ml respectively; P < 0.001), pneumonia (13.5 vs 25.0%; P = 0.035), pleural effusion (3.8 vs 13.5%; P = 0.014), and chest drainage (7.5(6-9) vs 8(7-9) days; P = 0.009) than hybrid procedure. There was no significant difference in 3-year overall survival rate and 3-year disease-free survival rate between the two group. Conclusions: Totally minimally invasive Ivor Lewis oesophagectomy may improve short-term outcomes and specifically reduce the incidence of pulmonary complications compared with hybrid procedure. The long-term overall survival and disease-free survival rates between the two groups were similar.

Paraconduit hiatal hernia following minimally invasive oesophagectomy in an emergent setting.

Paraconduit hiatal hernia (PHH) remains a rare complication from oesophagectomies. Although minimally invasive oesophagectomies (MIO) for oesophageal cancer offer many advantages over open oesophagectomies (OO), the incidence of PHH appears to buckle this trend. As such, there is paucity in the current literature on the preferred approach as well as the management of PHH post-MIO. We present 2 emergent cases of post-MIO PHH. The laparoscopic approach of PHH repair appears feasible and safe even in the emergent setting. However, most advocate for the avoidance of emergent surgery altogether by astute care and prevention of PHH formation, or with early repair, if found asymptomatic PHH during surveillance scan.

Completely minimally invasive versus hybrid Ivor-Lewis oesophagectomy for oesophageal and gastro-oesophageal junctional cancer: a UK multi-centre comparative study.

BACKGROUND: Limited robust evidence exists comparing outcomes following completely minimally invasive oesophagectomy (CMIO) to hybrid oesophagectomy (HO) in the treatment of resectable oesophageal and gastro-oesophageal junctional (GOJ) cancer. This multi-centre study aims to assess postoperative morbidity between HO and CMIO according to the full Esophagectomy Complications Consensus Group (ECCG) complication platform. METHODS: All consecutive patients undergoing an Ivor-Lewis HO or Ivor-Lewis CMIO for cancer between 2016 and 2018 in three UK tertiary centres were included. The primary study outcome was 30-day overall complications, evaluated by the ECCG complication subgroups. Secondary outcomes included survival outcomes and perioperative parameters between the two approaches. RESULTS: Of the 382 patients included, 228 (59.7%) patients had HOs and 154 (40.3%) patients had CMIOs with no inter-group baseline differences. Patients undergoing CMIO experienced less 30-day postoperative complications compared to those under undergoing HO (43.5% vs 57.0%, p = 0.010). ECCG defined pulmonary and infective complications were less frequent in the CMIO group. Anastomotic leak rates and oncological outcomes were similar between the two groups. Independent predictors of 30-day postoperative complications include surgical approach with HO and high ASA grade on multivariable analysis. CONCLUSIONS: Ivor-Lewis CMIO demonstrates superior short-term surgical outcomes when compared to Ivor-Lewis HO with no compromise in oncological feasibility. Anastomotic leak rates were equivalent between both groups. A robust randomised controlled trial is required to validate the findings of this study.

Pre-Emptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy (the preSPONGE Trial): Study Protocol for a Multicenter Randomized Controlled Trial.

INTRODUCTION: Anastomotic leakage (AL) accounts for a significant proportion of morbidity following oesophagectomy. Endoluminal negative pressure (ENP) therapy via a specifically designed polyurethane foam (EsoSponge®, B.Braun Medical, Melsungen, Germany) has become the standard of care for AL in many specialized centres. The prophylactic (pENP) application of this technique aims to reduce postoperative morbidity and is a novel approach which has not yet been investigated in a prospective study. The aim of this study is therefore to assess the effect of pENP at the anastomotic site in high-risk patients undergoing minimally invasive transthoracic Ivor Lewis oesophagectomy. METHODS AND ANALYSIS: The study design is a prospective, multi-centre, two-arm, parallel-group, randomised controlled trial and will be conducted in two phases. Phase one is a randomised feasibility and safety pilot trial involving 40 consecutive patients. After definitive sample size calculation, additional patients will be included accordingly during phase two. The primary outcome of the study will be the postoperative length of hospitalization until reaching previously defined "fit for discharge criteria". Secondary outcomes will include postoperative morbidity, mortality and postoperative AL-rates based on 90-day follow-up. A confirmatory analysis based on intention-to-treat will be performed. ETHICS AND DISSEMINATION: The ethics committee of the University of Zurich approved this study (2019-00562), which has been registered with ClinicalTrials.gov on 14.11.2019 (NCT04162860) and the Swiss National Clinical Trials Portal (SNCTP000003524). The results of the study will be published and presented at appropriate conferences.

Does robot-assisted minimally invasive oesophagectomy have superiority over thoraco-laparoscopic minimally invasive oesophagectomy in lymph node dissection?

Although robotic techniques have been used for oesophagectomy for many years, whether robot-assisted minimally invasive oesophagectomy (RAMIE) can actually improve outcomes and surpass thoraco-laparoscopic minimally invasive oesophagectomy (MIE) in the success rate of lymph node dissection remains to be empirically demonstrated. Therefore, we performed this systematic review and meta-analysis of case-control studies to systematically compare the effect of lymph node dissection and the incidence of vocal cord palsy between RAMIE and MIE. The PubMed, EMBASE, and Web of Science databases were systematically searched up to December 1, 2019, for case-control studies that compared RAMIE with MIE. Thirteen articles were included, with a total of 1,749 patients with esophageal cancer, including 866 patients in the RAMIE group and 883 patients in the MIE group. RAMIE yielded significantly larger numbers of total dissected lymph nodes (WMD = 1.985; 95% CI, 0.448-3.523; P = 0.011) and abdominal lymph nodes (WMD = 1.686; 95% CI, 0.420-2.951; P = 0.009) as well as lymph nodes along RLN (WMD = 0.729; 95% CI, 0.348-1.109; P < 0.001) than MIE. Additionally, RAMIE could significantly decrease estimated blood loss (WMD = -11.208; 95% CI, -19.358 to -3.058; P = 0.007) and the incidence of vocal cord palsy (OR = 0.624; 95% CI, 0.411-0.947; P = 0.027) compared to MIE. Compared with MIE, RAMIE resulted in a higher total lymph node yield and a higher lymph node yield in the abdomen and along RLN, along with reduced blood loss during surgery and the incidence of vocal cord palsy. Therefore, RAMIE could be considered to be a standard treatment, with less blood loss, lower incidence of vocal cord palsy, and more radical lymph node dissection, exhibiting superiority over MIE.

Severe weight loss after minimally invasive oesophagectomy is associated with poor survival in patients with oesophageal cancer at 5 years.

BACKGROUND: Patients often experience severe weight loss after oesophagectomy. Enteral nutrition via a feeding jejunostomy tube (FT) is commonly practised. This study aimed to assess the effect of severe weight loss postoperatively and enteral nutrition via an FT on long-term prognosis after oesophagectomy. METHODS: This study analysed 317 patients who underwent minimally invasive oesophagectomy at Kobe University Hospital and Hyogo Cancer Center from 2010 to 2015. The patients' body weight was evaluated at 3 months postoperatively. They were organised into the severe weight loss (n = 65) and moderate weight loss (n = 252) groups. Furthermore, they were categorised into the FT group (184 patients who had an FT placed during oesophagectomy) and no-FT group (133 patients without FT). Patients (119 per group) matched for the FT and no-FT groups were identified via propensity score matching. RESULTS: The 5-year overall survival (OS) rate in the severe weight loss group was significantly lower (p = 0.024). In the multivariate analysis, tumour invasion depth (pT3-4), preoperative therapy and severe weight loss had a worse OS (hazard ratio = 1.89; 95% confidence interval = 1.12-3.17, hazard ratio = 2.11; 95% confidence interval = 1.25-3.54, hazard ratio = 1.82; 95% confidence interval = 1.02-3.524, respectively). No significant differences in the number of severe weight loss patients and OS were found between the FT and no-FT groups. CONCLUSION: Severe weight loss is significantly associated with poor OS. In addition, enteral nutrition via an FT did not improve the severe weight loss and OS.

Minimally invasive oesophagectomy: The first case report of a thoracolaparoscopic oesophagectomy done in the Caribbean.

INTRODUCTION: Minimally invasive oesophagectomy is one of the options in the armamentarium of a modern surgeon when faced with treating oesophageal cancer. Trinidad and Tobago has successfully treated a patient using this method. This case report adds to the rich surgical history in the Caribbean. CASE PRESENTATION: Our patient presented with progressive dysphagia, and after being worked up was diagnosed with oesophageal cancer. He underwent neoadjuvant chemotherapy and had a minimally invasive McKeown oesophagectomy done by a fellowship trained, advanced laparoscopic oesophageal and gastric surgeon. CONCLUSION: The patient had an uneventful recovery and was tumor free with excellent quality of life at 4 years, showing that the Caribbean is keeping up with the rest of the surgical world.

Robotic-assisted single-incision gastric mobilization for minimally invasive oesophagectomy for oesophageal cancer: preliminary results.

OBJECTIVES: With the gradual acceptance of robotic-assisted surgery to treat oesophageal cancer and the application of a single-port approach in several abdominal procedures, we adopted a single-port technique in robotic-assisted minimally invasive oesophagectomy during the abdominal phase for gastric mobilization and abdominal lymph node dissection. METHODS: Robotic-assisted oesophagectomy and mediastinal lymph node dissection in the chest were followed by robotic-assisted gastric mobilization and conduit creation with abdominal lymph node dissection, which were performed via a periumbilicus single incision. The oesophagogastrostomy was accomplished either in the chest (Ivor Lewis procedure) or neck (McKeown procedure) depending on the status of the proximal resection margin. RESULTS: The procedure was successfully performed on 11 patients with oesophageal cancer from January 2017 to December 2018 in our institute. No surgical or in-hospital deaths occurred, though we had one case each of anastomotic leakage, pneumonia and hiatal hernia (9%). CONCLUSIONS: Robotic single-incision gastric mobilization for minimally invasive oesophagectomy for treating oesophageal cancer seems feasible. Its value in terms of perioperative outcome and long-term survival results awaits future evaluation.

Effectiveness and safety of minimally invasive Ivor Lewis and McKeown oesophagectomy in Chinese patients with stage IA-IIIB oesophageal squamous cell cancer: a multicentre, non-interventional and observational study.

OBJECTIVES: To compare the long-term overall survival and outcomes of patients with oesophageal squamous cell cancer treated with minimally invasive McKeown or Ivor Lewis oesophagectomy. METHODS: A multicentre, non-interventional, retrospective, observational study was performed in oesophageal squamous cell cancer patients pathologically confirmed with stage IA-IIIB middle or lower thoracic tumours who underwent minimally invasive oesophagectomy between 1 January 2010 and 30 June 2017 in 7 hospitals in China. Cox proportional hazards models assessed factors associated with overall survival and disease recurrence. The primary outcome was overall survival and cancer recurrence; the secondary outcomes included number of lymph nodes resected, 30-day mortality and postoperative complications. RESULTS: A total of 1540 patients were included (950 McKeown, 590 Ivor Lewis). The mean age was 61.6 years, and 1204 were male. The mean number of lymph nodes removed during the McKeown procedure was 21.2 ± 11.4 compared with 14.8 ± 8.9 in Ivor Lewis patients (P < 0.001). The 5-year overall survival rates were 67.9% (McKeown) and 55.0% (Ivor Lewis). McKeown oesophagectomy was associated with improved overall survival (Ivor Lewis versus McKeown hazard ratio 1.36, 95% confidence interval 1.11-1.66; P = 0.003), particularly in patients with stage T3 tumours (middle thoracic oesophagus). However, postoperative complications occurred more frequently following McKeown oesophagectomy (42.2% vs 17.6% Ivor Lewis; P < 0.001). CONCLUSIONS: Minimally invasive McKeown oesophagectomy was associated with improved overall survival and a decreased risk of disease recurrence, while Ivor Lewis patients had fewer postoperative complications. McKeown oesophagectomy may represent the optimal technique for patients with stage T3 tumours. CLINICAL TRIAL REGISTRATION: CLINICALTRIAL.GOV: NCT03428074.

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.

Paravertebral catheter analgesia for minimally invasive Ivor Lewis oesophagectomy.

BACKGROUND: Oesophagectomy is a major complex operation associated with significant morbidity and mortality. Epidural analgesia has long been the gold standard postoperative analgesia but is associated with side-effects like hypotension, epidural haematoma and infection. In an attempt to lower morbidity and enhance recovery postoperatively, we have adopted the use of paravertebral catheter analgesia (PVCA) for patients undergoing totally minimal invasive oesophagectomy (TMIO). METHODS: Our objective was to review the current literature about the use of both PVCA and epidural analgesia. In addition, we evaluated the effect of PVCA in a large group of patients undergoing TMIO for cancer. We reviewed the records of 100 consecutive patients who had a TMIO with PVCA, spinal morphine, and PCA. Prospective independent scoring of postoperative pain, length of stay, high-dependency unit (HDU) stay, PVCA failure, the use of patient-controlled analgesia (PCA), and the use of vasoconstrictor medication postoperatively was analysed. RESULTS: One hundred consecutive patients received PVCA with PCA after the TMIO. Catheter related failures occurred in 4 cases. The median pain score over each of the 5 days were 0. The average pain score was highest in the first 24 hours and decreased over the next 4 days postoperatively. The use of PCA was highest in the first 2 days and reduced daily over the subsequent 3 days. Seven patients required rescue analgesia in the form of intercostal nerve (ICN) block. Spinal morphine was successful in 94% of cases. Vasoconstrictors were required in 19% on day 1 and 3% on day 2, postoperatively. CONCLUSIONS: Intraoperative placement of PVCA results in good postoperative pain control after a TMIO. This technique is simple, safe, reproducible and with very low failure rates. Therefore, it should be used instead of epidural catheter analgesia.