Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial

<p>Abstract</p> <p>Background</p> <p>Open transthoracic oesophagectomy is the standard treatment for infracarinal resectable oesophageal carcinomas, although it is associated with high mortality and morbidity rates of 2 to 10% and 30 to 50%, respectively, for both the abdominal and thoracic approaches. The worldwide popularity of laparoscopic techniques is based on promising results, including lower postoperative morbidity rates, which are related to the reduced postoperative trauma. We hypothesise that the laparoscopic abdominal approach (laparoscopic gastric mobilisation) in oesophageal cancer surgery will decrease the major postoperative complication rate due to the reduced surgical trauma.</p> <p>Methods/Design</p> <p>The MIRO trial is an open, controlled, prospective, randomised multicentre phase III trial. Patients in study arm A will receive laparoscopic-assisted oesophagectomy, i.e., a transthoracic oesophagectomy with two-field lymphadenectomy and laparoscopic gastric mobilisation. Patients in study arm B will receive the same procedure, but with the conventional open abdominal approach. The primary objective of the study is to evaluate the major postoperative 30-day morbidity. Secondary objectives are to assess the overall 30-day morbidity, 30-day mortality, 30-day pulmonary morbidity, disease-free survival, overall survival as well as quality of life and to perform medico-economic analysis. A total of 200 patients will be enrolled, and two safety analyses will be performed using 25 and 50 patients included in arm A.</p> <p>Discussion</p> <p>Postoperative morbidity remains high after oesophageal cancer surgery, especially due to major pulmonary complications, which are responsible for 50% of the postoperative deaths. This study represents the first randomised controlled phase III trial to evaluate the benefits of the minimally invasive approach with respect to the postoperative course and oncological outcomes in oesophageal cancer surgery.</p> <p>Trial Registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT00937456">NCT00937456</a> (ClinicalTrials.gov)</p

Large gastrointestinal stromal tumours of the stomach: Is laparoscopy reasonable?

Background: Laparoscopic resection (LR) offers significant advantages compared to open resections for gastric gastrointestinal stromal tumours (GISTs). We aimed to evaluate whether LR outcomes jeopardised short and long-term outcomes of patients with large GISTs. Patients and Methods: Among 50 patients undergoing surgery for gastric GISTs, 12 underwent LR for large GISTs (>5 cm). Their characteristics, perioperative results and survival were retrospectively compared to those of 22 patients who underwent LR for 'small GIST'. Results: The two groups were similar regarding demographics, rate of wedge resection and mean blood loss. No patient required transfusion or conversion. Operative time was significantly increased in the 'large GIST' group (160 min vs 112 min, P = 0.001). Mean tumour size was significantly lower in the 'small GIST' group (8.4 cm vs 2.4 cm, P = 0.0001). Resection margins were negative. The mortality rate was nil and the overall morbidity rates was similar in both groups. Median length of hospital stay was significantly increased in the 'large GIST' group (7 days vs 5 days, P = 0.004). Median follow-up was 47 months and one patient in the 'small GIST' group developed recurrence and died during follow-up 11 years after surgery. No patient died during follow-up. Conclusions: LR for large GISTs is safe and technically feasible and does not negatively influence the oncologic course. Prospective randomised trials should be performed before using this approach in routine surgical care

Impact of laparoscopy in patients aged over 70 years requiring distal pancreatectomy: a French multicentric comparative study

International audienceBACKGROUND:Few data are available concerning short-term results of minimally invasive surgery in patients > 70 years old requiring distal pancreatectomy. The aim of this study was to compare short-term results after laparoscopic (LDP) versus open distal pancreatectomy (ODP) in this subgroup of patients.METHODS:All patients > 70 years who underwent distal pancreatectomy in 3 expert centers between 1995 and 2017 were included and data were retrospectively analyzed. Demographic, intraoperative data and postoperative outcomes in LDP and ODP groups were compared.RESULTS:A distal pancreatectomy was performed in 109 elderly patients; LDP group included 53 patients while ODP group included 56. There were 55 (50.5%) males and 54 (49.5%) women with a median age of 75 years (range 70-87). Fifty (45.9%) patients were 70-74, 40 (36.7%) patients were 75-79, and 19 (17.4%) patients were over 80 years. Nine (8.2%) patients required conversion to open surgery. The median operative time was not different between LDP and ODP (204 vs. 220 min, p = 0.62). The intraoperative blood loss was significantly lower in the LDP group (238 ± 312 vs. 425 ± 582 ml, p = 0.009) with no difference regarding the intraoperative transfusion rate. 90-day mortality (0 vs. 5%, p = 0.42), overall complication (45.4 vs. 51.8%, p = 0.53), major complication (18.2 vs. 12.5%, p = 0.43), grade B/C pancreatic fistula (6.8 vs. 7.1%, p = 0.71), were comparable in the 2 groups. Only postoperative confusion rate was significantly lower in the LDP group (4.5 vs. 25%, p = 0.01). Median length of stay was significantly lower in the LDP group (14 ± 10 vs. 16 ± 11 days, p = 0.04). R0 resection was performed in 94% of LDP patients and 89% in ODP patients without significant difference (p = 0.73).CONCLUSIONS:The laparoscopic approach seems to reduce blood loss, postoperative confusion, and length of stay in elderly patients requiring distal pancreatectomy

Laparoscopic repeat surgery for gastro-oesophageal reflux disease: Results of the analyses of a cohort study of 117 patients from a multicenter experience

International audienceBackground: Short and long-term outcomes after repeat anti-reflux surgery (RARS) are still debated and generally not considered as satisfying as after primary anti-reflux surgery (PARS). The aim of this study was to evaluate functional outcomes after RARS and risk factors associated to intra-operative and post-operative complications.Methods: This is a multicenter retrospective survey from four European laparoscopic centers. Patients who underwent elective RARS from January 2005 to October 2017 for dysphagia or for persistent reflux disease refractory to medical treatment were analyzed. Data on demographic characteristics, including type and timing of previous operations as well as intra-operative details (surgical technique, type of RARS, conversion to open surgery, prosthetic material placement) were collected. Patients who underwent operations in the emergency setting, interventions mixed with bariatric procedures and PARS performed in other surgical departments were not included in this study. Primary endpoint of this study was to evaluate risk factors associated with intraoperative and postoperative complications. Secondary endpoint was to evaluate clinical outcomes and to identify any possible correlation with clinical and surgical parameters.Results: Among 1662 patients who underwent PARS, failure occurred in 174 (10.5%) patients. Repeat surgery was performed in 117 (7%) patients, after a mean time of 80 months (range 4-315). RARS was carried out laparoscopically in 88% of cases. Prosthetic mesh to reinforce hiatoplasty was used in 22.2% of patients. Intra-operative upper gastro-intestinal tract's injuries occurred in 6 (5.1%) patients. Perioperative mortality was nil and 13 (11.1%) patients experienced postoperative complications. Mean length of hospital stay was 9.6 ± 6.4 days. Based on a multivariable analysis, age >70 years (OR 1.074, C.I.95% 1.018-1.133, p = 0.008) and body mass index (BMI) 70 years) and low BMI (<23 kg/m2) were factor predicting perioperative complications. The use of prosthesis for hiatoplasty was associated to better functional outcomes

Five-Year Survival Outcomes of Hybrid Minimally Invasive Esophagectomy in Esophageal Cancer

International audienceAvailable data comparing the long-term results of hybrid minimally invasive esophagectomy (HMIE) with that of open esophagectomy are conflicting, with similar or even better results reported for the minimally invasive esophagectomy group.Objective: To evaluate the long-term, 5-year outcomes of HMIE vs open esophagectomy, including overall survival (OS), disease-free survival (DFS), and pattern of disease recurrence, and the potential risk factors associated with these outcomes.Design, setting, and participants: This randomized clinical trial is a post hoc follow-up study that analyzes the results of the open-label Multicentre Randomized Controlled Phase III Trial, which enrolled patients from 13 different centers in France and was conducted from October 26, 2009, to April 4, 2012. Eligible patients were 18 to 75 years of age and were diagnosed with resectable cancer of the middle or lower third of the esophagus. After exclusions, patients were randomized to either the HMIE group or the open esophagectomy group. Data analysis was performed on an intention-to-treat basis from November 19, 2019, to December 4, 2020.Interventions: Hybrid minimally invasive esophagectomy (laparoscopic gastric mobilization with open right thoracotomy) was compared with open esophagectomy.Main outcomes and measures: The primary end points of this follow-up study were 5-year OS and DFS. The secondary end points were the site of disease recurrence and potential risk factors associated with DFS and OS.Results: A total of 207 patients were randomized, of whom 175 were men (85%), and the median (range) age was 61 (23-78) years. The median follow-up duration was 58.2 (95% CI, 56.5-63.8) months. The 5-year OS was 59% (95% CI, 48%-68%) in the HMIE group and 47% (95% CI, 37%-57%) in the open esophagectomy group (hazard ratio [HR], 0.71; 95% CI, 0.48-1.06). The 5-year DFS was 52% (95% CI, 42%-61%) in the HMIE group vs 44% (95% CI, 34%-53%) in the open esophagectomy group (HR, 0.81; 95% CI, 0.55-1.17). No statistically significant difference in recurrence rate or location was found between groups. In a multivariable analysis, major intraoperative and postoperative complications (HR, 2.21; 95% CI, 1.41-3.45; P < .001) and major pulmonary complications (HR, 1.94; 95% CI, 1.21-3.10; P = .005) were identified as risk factors associated with decreased OS. Similarly, multivariable analysis of DFS identified overall intraoperative and postoperative complications (HR, 1.93; 95% CI, 1.28-2.90; P = .002) and major pulmonary complications (HR, 1.85; 95% CI, 1.19-2.86; P = .006) as risk factors.Conclusions and relevance: This study found no difference in long-term survival between the HMIE and open esophagectomy groups. Major postoperative overall complications and pulmonary complications appeared to be independent risk factors in decreased OS and DFS, providing additional evidence that HMIE may be associated with improved oncological results compared with open esophagectomy primarily because of a reduction in postoperative complications

Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer

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Health-related Quality of Life Following Hybrid Minimally Invasive Versus Open Esophagectomy for Patients With Esophageal Cancer, Analysis of a Multicenter, Open-label, Randomized Phase III Controlled Trial

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