Dataset Information

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

ABSTRACT: 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.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.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.NCT00937456 (ClinicalTrials.gov).

SUBMITTER: Briez N

PROVIDER: S-EPMC3156811 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Briez Nicolas N Piessen Guillaume G Bonnetain Franck F Brigand Cécile C Carrere Nicolas N Collet Denis D Doddoli Christophe C Flamein Renaud R Mabrut Jean-Yves JY Meunier Bernard B Msika Simon S Perniceni Thierry T Peschaud Frédérique F Prudhomme Michel M Triboulet Jean-Pierre JP Mariette Christophe C

BMC cancer 20110723

<h4>Background</h4>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 lapar ...[more]

PMID: 21781337

Similar Datasets

Project description:Background Oesophageal cancer is the eighth most common cause of cancer worldwide. In recent years, the frequency to use minimally invasive surgical methods for esophagectomy has been increased, but its real advantages over conventional surgery is still remains. The aim of this study is to compare patients who underwent open three-stage transthoracic oesophagectomy with those who underwent minimally invasive thoraco-laparoscopic oesophagectomy (MIO) to ascertain the feasibility, safety, and clinical advantages of the MIO. Methods We did a multicentre prospective, open and parallel, randomised controlled trial in six study centres between April 1st, 2014, and April 30th, 2018. Patients aged 18–75 years with resectable middle and upper esophageal cancer were randomly assigned via a computer-generated randomisation sequence to receive either open three-stage transthoracic oesophagectomy (Group A) or MIO (Group B). The perioperative outcomes were to compare operative time, intraoperative blood loss, total expenses in hospital, hospital stay, the number and location of lymph nodes harvested and respiratory complications within 30 days. This trial is registered with ClinicalTrials.gov Identifier: NCT02355249. Results We randomly assigned 339 patients to the Group A and 156 to the Group B. No differences emerged in terms of age (year) [(61.52±8.52) vs. (60.25±6.28), P=0.67], the median lengths of hospital stay (day) [(16.28±8.02) vs. (17.15±11.74), P=0.08]. Group A has less intraoperative blood loss (mL) [(241.1±165.8) vs. (274.0±169.8), P<0.05] and total expenses in hospital (?) [(92,076±27,889) vs. (107,669±32,655), P<0.05], shorter operative time (min) [(267±92.2) vs. (364.3±99.43), P<0.05]. While Group B has palpable advantage in the number [(18.30±11.44) vs. (23.08±12.45), P<0.05] and location [(4.30±2.16) vs. (5.44±2.37), P<0.05] of lymph nodes harvested. The proportion of respiratory complications within 30 days was no statistical difference in the Group B [21/156 (13.5%)] compared to the Group A [45/339 (13.3%)] (Chi-square sig =0.934, P>0.05). Meanwhile, the study makes clear that tumour size has no correlation to operative time (Spearman r =?0.014, P>0.05) and intraoperative blood loss (Spearman r =0.078, P>0.05). Conclusions Compared to open three-stage transthoracic oesophagectomy, MIO has prominent representation in lymph nodes harvested which is fatal to estimate prognosis and plan sequential treatment plan, although, MIO has some disadvantage such as longer operative time, more intraoperative blood loss and total expenses in hospital which is conflicting to previous observational studies conclusion. There is no statistical difference in respiratory complications within 30 days between the two surgical approaches. Next step, survival rate after 2 years will be analyzed and published after the follow-up work is finished.

Project description:Oesophageal cancer is the eighth most common cause of cancer worldwide. In 2009 in China, the incidence and death rate of oesophageal cancer was 22.14 per 100?000 person-years and 16.77 per 100?000 person-years, respectively, the highest in the world. Minimally invasive oesophagectomy (MIO) was introduced into clinical practice with the aim of reducing the morbidity rate. The mechanisms of MIO may lie in minimising the reaction to surgical injury and inflammation. There are some randomised trials regarding minimally invasive versus open oesophagectomy, with 100-850 subjects enrolled. To date, no large randomised controlled trial comparing minimally invasive versus open oesophagectomy has been reported in China, where squamous cell carcinoma predominated over adenocarcinoma of the oesophagus.This is a 3?year multicentre, prospective, randomised, open and parallel controlled trial, which aims to compare the effectiveness of minimally invasive thoraco-laparoscopic oesophagectomy to open three-stage transthoracic oesophagectomy for resectable oesophageal cancer. Group A patients receive MIO which involves thoracoscopic oesophagectomy and laparoscopic gastric mobilisation with cervical anastomosis. Group B patients receive the open three-stage transthoracic oesophagectomy which involves a right thoracotomy and laparotomy with cervical anastomosis. Primary endpoints include respiratory complications within 30?days after operation. The secondary endpoints include other postoperative complications, influences on pulmonary function, intraoperative data including blood loss, operative time, the number and location of lymph nodes dissected, and mortality in hospital, the length of hospital stay, total expenses in hospital, mortality within 30?days, survival rate after 2?years, postoperative pain, and health-related quality of life (HRQoL). Three hundred and twenty-four patients in each group will be needed and a total of 648 patients will finally be enrolled into the study.The study protocol has been approved by the Institutional Ethics Committees of all participating institutions. The findings of this trial will be disseminated to patients and through peer-reviewed publications and international presentations.NCT02355249.

Project description:Maintenance of quality of life is the primary goal during treatment of brain metastases (BM). This is a protocol of an ongoing phase III randomised multicentre study. This study aims to determine the exact additional palliative value of stereotactic radiosurgery (SRS) over whole brain radiotherapy (WBRT) in patients with 4-10 BM.The study will include patients with 4-10 BM from solid primary tumours diagnosed on a high-resolution contrast-enhanced MRI scan with a maximum lesional diameter of 2.5 cm in any direction and a maximum cumulative lesional volume of 30 cm3. Patients will be randomised between WBRT in five fractions of 4 Gy to a total dose of 20 Gy (standard arm) and single dose SRS to the BMs (study arm) in the range of 15-24 Gy. The largest BM or a localisation in the brainstem will determine the prescribed SRS dose. The primary endpoint is difference in quality of life (EQ5D EUROQOL score) at 3 months after radiotherapy with regard to baseline. Secondary endpoints are difference in quality of life (EQ5D EUROQOL questionnaire) at 6, 9 and 12 months after radiotherapy with regard to baseline. Other secondary endpoints are at 3, 6, 9 and 12 months after radiotherapy survival, Karnofsky ? 70, WHO performance status, steroid use (mg), toxicity according to CTCAE V4.0 including hair loss, fatigue, brain salvage during follow-up, type of salvage, time to salvage after randomisation and Barthel index. Facultative secondary endpoints are neurocognition with the Hopkins verbal learning test revised, quality of life EORTC QLQ-C30, quality of life EORTC BN20 brain module and fatigue scale EORTC QLQ-FA13.Worldwide, most patients with more than 4 BM will be treated with WBRT. Considering the potential advantages of SRS over WBRT, i.e. limiting radiation doses to uninvolved brain and a high rate of local tumour control by just a single treatment with fewer side effects, such as hair loss and fatigue, compared to WBRT, SRS might be a suitable alternative for patients with 4-10 BM.Trial registration number: NCT02353000 , trial registration date 15th January 2015, open for accrual 1st July 2016, nine patients were enrolled in this trial on 14th April 2017.

Project description:IntroductionLung cancer is a leading cause of cancer deaths worldwide and surgery remains the main treatment for early stage disease. Prior to the introduction of video-assisted thoracoscopic surgery (VATS), lung resection for cancer was undertaken through an open thoracotomy. To date, the evidence base supporting the different surgical approaches is based on non-randomised studies, small randomised trials and is focused mainly on short-term in-hospital outcomes.Methods and analysisThe VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer study is a UK multicentre parallel group randomised controlled trial (RCT) with blinding of outcome assessors and participants (to hospital discharge) comparing the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open lobectomy for treatment of lung cancer. We will test the hypothesis that VATS lobectomy is superior to open lobectomy with respect to self-reported physical function 5?weeks after randomisation (approximately 1?month after surgery). Secondary outcomes include assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pathologic N2 (pN2) disease and disease-free survival), overall survival and health related quality of life to 1?year. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.Ethics and disseminationThis trial has been approved by the UK (Dulwich) National Research Ethics Service Committee London. Findings will be written-up as methodology papers for conference presentation, and publication in peer-reviewed journals. Many aspects of the feasibility work will inform surgical RCTs in general and these will be reported at methodology meetings. We will also link with lung cancer clinical studies groups. The patient and public involvement group that works with the Respiratory Biomedical Research Unit at the Brompton Hospital will help identify how we can best publicise the findings.Trial registration numberISRCTN13472721.

Project description:BackgroundDespite standard curative-intent treatment with neoadjuvant cisplatin-based chemotherapy, followed by radical surgery in eligible patients, muscle-invasive urothelial carcinoma has a high recurrence rate and no level 1 evidence for adjuvant therapy. We aimed to evaluate atezolizumab as adjuvant therapy in patients with high-risk muscle-invasive urothelial carcinoma.MethodIn the IMvigor010 study, a multicentre, open-label, randomised, phase 3 trial done in 192 hospitals, academic centres, and community oncology practices across 24 countries or regions, patients aged 18 years and older with histologically confirmed muscle-invasive urothelial carcinoma and an Eastern Cooperative Oncology Group performance status of 0, 1, or 2 were enrolled within 14 weeks after radical cystectomy or nephroureterectomy with lymph node dissection. Patients had ypT2-4a or ypN+ tumours following neoadjuvant chemotherapy or pT3-4a or pN+ tumours if no neoadjuvant chemotherapy was received. Patients not treated with neoadjuvant chemotherapy must have been ineligible for or declined cisplatin-based adjuvant chemotherapy. No post-surgical radiotherapy or previous adjuvant chemotherapy was allowed. Patients were randomly assigned (1:1) using a permuted block (block size of four) method and interactive voice-web response system to receive 1200 mg atezolizumab given intravenously every 3 weeks for 16 cycles or up to 1 year, whichever occurred first, or to observation. Randomisation was stratified by previous neoadjuvant chemotherapy use, number of lymph nodes resected, pathological nodal status, tumour stage, and PD-L1 expression on tumour-infiltrating immune cells. The primary endpoint was disease-free survival in the intention-to-treat population. Safety was assessed in patients who either received at least one dose of atezolizumab or had at least one post-baseline safety assessment. This trial is registered with ClinicalTrials.gov, NCT02450331, and is ongoing but not recruiting patients.FindingsBetween Oct 5, 2015, and July 30, 2018, we enrolled 809 patients, of whom 406 were assigned to the atezolizumab group and 403 were assigned to the observation group. Median follow-up was 21·9 months (IQR 13·2-29·8). Median disease-free survival was 19·4 months (95% CI 15·9-24·8) with atezolizumab and 16·6 months (11·2-24·8) with observation (stratified hazard ratio 0·89 [95% CI 0·74-1·08]; p=0·24). The most common grade 3 or 4 adverse events were urinary tract infection (31 [8%] of 390 patients in the atezolizumab group vs 20 [5%] of 397 patients in the observation group), pyelonephritis (12 [3%]) vs 14 [4%]), and anaemia (eight [2%] vs seven [2%]). Serious adverse events occurred in 122 (31%) patients who received atezolizumab and 71 (18%) who underwent observation. 63 (16%) patients who received atezolizumab had a treatment-related grade 3 or 4 adverse event. One treatment-related death, due to acute respiratory distress syndrome, occurred in the atezolizumab group.InterpretationTo our knowledge, IMvigor010 is the largest, first-completed phase 3 adjuvant study to evaluate the role of a checkpoint inhibitor in muscle-invasive urothelial carcinoma. The trial did not meet its primary endpoint of improved disease-free survival in the atezolizumab group over observation. Atezolizumab was generally tolerable, with no new safety signals; however, higher frequencies of adverse events leading to discontinuation were reported than in metastatic urothelial carcinoma studies. These data do not support the use of adjuvant checkpoint inhibitor therapy in the setting evaluated in IMvigor010 at this time.FundingF Hoffmann-La Roche/Genentech.

Project description:BackgroundThe role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension. We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery.MethodsIn this randomised controlled trial at 30 centres in Europe and North and South America, we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg. We randomly allocated patients to either a high level of positive end-expiratory pressure (12 cm H2O) with recruitment manoeuvres (higher PEEP group) or a low level of pressure (≤2 cm H2O) without recruitment manoeuvres (lower PEEP group). We used a centralised computer-generated randomisation system. Patients and outcome assessors were masked to the intervention. Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5. Analysis was by intention-to-treat. The study is registered at Controlled-Trials.com, number ISRCTN70332574.FindingsFrom February, 2011, to January, 2013, 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group. Six patients were excluded from the analysis, four because they withdrew consent and two for violation of inclusion criteria. Median levels of positive end-expiratory pressure were 12 cm H2O (IQR 12-12) in the higher PEEP group and 2 cm H2O (0-2) in the lower PEEP group. Postoperative pulmonary complications were reported in 174 (40%) of 445 patients in the higher PEEP group versus 172 (39%) of 449 patients in the lower PEEP group (relative risk 1·01; 95% CI 0·86-1·20; p=0·86). Compared with patients in the lower PEEP group, those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs.InterpretationA strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications. An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure, without recruitment manoeuvres.FundingAcademic Medical Center (Amsterdam, Netherlands), European Society of Anaesthesiology.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets