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 However, the main competence of the . Hybrid Minimally Invasive Esophagectomy Does Not Compromise Long-Term Survival. David H. Ilson, MD, PhD, . . This is a randomized controlled trial designed to compare robot-assisted thoracic approach with open transthoracic esophagectomy (Ivor Lewis technique) as a surgical treatment for resectable esophageal cancer. Search.
. [Hybrid minimally invasive esophagectomy for esophageal cancer-MIRO trial] [Hybrid minimally invasive esophagectomy for esophageal cancer-MIRO trial] Chirurg. [Article in German] Authors S Inderhees 1 .
Esophageal cancer is one of the most common digestive tract cancers worldwide. 10.1186/1471-2407-11-310 [Europe PMC free article] [Google Scholar] We found that esophagectomy had substantial effects upon short-term HRQOL. World J Surg. If this includes the upper portion of the stomach (for cancers in the distal third) it is sometimes called an esophagogastrectomy. "Patients requiring surgery for esophageal cancer fare better after undergoing a hybrid minimally invasive esophagectomy (HMIO) compared to an open esophagectomy (OO), according to long-term results of the MIRO trial to be presented at the ESMO 2017 Congress in Madrid. An esophagectomy is surgical resection of the esophagus. Therefore, the aim of the present study was to analyse the short- and long-term outcomes from RCTs comparing MIO with open . (HMIE) with that of open esophagectomy are conflicting, with similar or even better results reported for the minimally invasive esophagectomy group. Methods/design: The MIRO trial is an open, controlled, prospective, randomised multicentre phase III trial. Methods: We . Ann Surg (2020) 271(6):1023-9. doi: 10.1097/sla.0000000000003559 . . In this 5-year follow-up to the Multicentre Randomized Controlled Phase III (MIRO) trial, Nuytens and colleagues 1 reported long-term outcomes of 207 patients who were randomized to undergo hybrid minimally invasive esophagectomy (HMIE; thoracotomy plus laparoscopic gastric mobilization) or open esophagectomy between 2009 to 2012 regarding survival, patterns of recurrence, and prognostic factors. Objective: To evaluate the long-term, 5-year outcomes of HMIE vs open esophagectomy, including overall survival (OS), disease-free survival (DFS . 2 This trial compared an open three-stage esophagectomy 16 with an open transhiatal esophagectomy. Interventions will include esophagectomy by: (1) open gastric Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trialthe MIRO trial. The postoperative complication after esophagectomy was defined according to Esophagectomy Complications Consensus Group system , of which the definition of pneumonia was based on temperature, .
Briez N, Piessen G, Bonnetain F, et al. In addition, at 30 . The results of HRQoL analyses in the French MIRO 18 trial showed that HMIO was associated with a statistically significant increase in global quality of life and social functioning compared with open oesophagectomy, which was possibly an effect of the reduced complication rate in the HMIO group. . . The first step toward The MIRO trial was the first to compare open two- MIE was by means of a laparoscopic transhiatal approach (9). Trial Design. Trial Design. The question remains what is the best approach to perform an esophagectomy; hybrid or totally minimally invasive? These effects for some specific parameters are, however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications. HE resulted in a lower incidence of major complications . Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the esophagus. BMC Cancer 2011;11:310. Quality of Life and Late Complications After Minimally Invasive Compared to Open Esophagectomy: Results of a Randomized Trial. esophagectomy (MIE), and from MIE to robot-assisted minimally invasive esophagectomy (RAMIE). A hybrid procedure that avoids the need for a technically challenging thoracoscopic phase has been proposed and investigated in a multicenter trial (i.e., the MIRO trial). Methods: We did a multicentre, open-label, randomised controlled . A randomized controlled trial was conducted to compare the hybrid approach (laparoscopic abdominal phase, open thoracic phase) to open esophagectomy: the MIRO trial. Minimally invasive esophagectomy approaches (MIE) and hybrid resections are increasingly used in oncologic surgery for esophageal carcinoma, showing advantages regarding postoperative convalescence. Esophagectomy is the mainstay treatment for cancer of the esophagus. 3 implementation of this technique on a nationwide level has already Legal entity responsible for the study. The most frequently performed surgical procedure is esophagectomy with two-field lymphadenectomy for which the minimally invasive approach is increasingly used (MIRO trial) . At the time of writing, the French MIRO (oesophagectoMIe pour cancer paR voie conventionnelle ou coeliO-assiste) trial is in progress, randomly allocating 200 patients between open and laparoscopically-assisted esophagectomy. phase III trial (MIRO trial), which found that HMIE had a lower incidence of perioperative complications (36% : vs Analysis of a multicenter, open-label, randomized phase III controlled trial. This procedure is often performed as part of treatment for early stage esophageal cancers . Previous meta-analyses comparing MIO to open oesophagectomy included also non-randomized studies, which may have introduced bias 18, 19. 5 Background: Surgical resection is regarded as the only curative option for resectable oesophageal cancer. The MIRO study was a multicenter, open-label, randomized controlled trial in which 207 patients aged 18 to 75 years who had resectable tumors in the middle or lower third of the esophagus were . Currently, there are several large randomized studies comparing newer surgical techniques with the Ivor Lewis esophagectomy. Quality of life and late complications after minimally invasive compared to open Esophagectomy: results of a randomized trial. . Mature results of the phase 3 study, with follow-up to a median of 48.8 months, MA, van Berge Henegouwen MI, et al. in the TIME (Traditional Invasive vs. Minimally Invasive Esophagectomy) trial comparing the outcomes of 115 British patients who underwent either E or MIE showed that besides a decrease in perioperative pulmonary complications, the two procedures were more or less similar. The feasibility robot-assisted versus thoracoscopic-assisted Ivor Lewis of a randomized controlled trial of esophagectomy esophagectomy for esophageal cancer: a propensity score- for esophageal cancer-the . Two multicenter randomized trials, TIME (Traditional Invasive Vs Minimally Invasive Esophagectomy) and MIRO (Open Versus Laparoscopically Assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial), were reported in the last decade and demonstrated that minimally invasive approaches to esophagectomy were . The number of elderly patients diagnosed with esophageal cancer rises. The MIRO Trial. Results of the MIRO Randomized Clinical Trial. Vs Minimally Invasive Esophagectomy) and MIRO (Open Versus Laparoscopically Assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial), were reported in the last decade and demonstrated that minimally invasive approaches to esophagectomy were associated with decreased surgical . BMC Surg (2002). Patients with esophageal cancer of the middle or lower third of the esophagus were included. [ 11] In 1999, Watson et al described a completely minimally invasive Ivor. Investigators report 5-year follow-up from the MIRO trial, a multicenter open-label phase 3 trial comparing hybrid minimally invasive esophagectomy (laparoscopic gastric mobilization plus open thoracotomy) to open esophagectomy. 5 MIE resulted in a lower incidence of respiratory complications compared with OTE with better quality of life, even after 1 year. Transhiatal esophagectomy: clinical . Minimally invasive esophagectomy. These effects for some specific parameters were however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications. Because no significant difference in the rate of R1 resections or lymph node yield could be found between the HMIE and the open esophagectomy groups in the MIRO trial report by Mariette et al, 11 the hypothesis was that the potential advantage in long-term oncological outcome in the HMIE group may be secondary to a decrease in the postoperative . As no surprise, MIRO trial demonstrated lower conversion rate compared to TIME trial because in MIRO trial one the two approaches was an open procedure. In the Traditional Invasive vs. Minimally invasive Esophagectomy (TIME) multicenter, randomized trial, conventional MIE was compared with OTE. Health-related quality of life following hybrid minimally invasive versus open esophagectomy for patients with esophageal cancer. However, the improvement in long-term survival is slow. LUGANO-MADRID - Patients requiring surgery for oesophageal cancer fare better after undergoing a hybrid minimally invasive oesophagectomy (HMIO) compared to an open oesophagectomy (OO), according to long-term results of the MIRO trial to be presented at the ESMO 2017 Congress in Madrid.
We assessed whether hybrid minimally invasive oesophagectomy (HMIO) reduces morbidity compared with OO. Minimally invasive esophagectomy (MIE) has the potential to limit surgical trauma and so improves short-term outcomes by limiting postoperative morbidity and mortality while preserving the thoroughness of the resection and the extent of lymph node dissection. Patients in study arm A will receive laparoscopic-assisted oesophagectomy, i.e., a transthoracic oesophagectomy with two-field lymphadenectomy and laparoscopic gastric mobilisation. Objective: To evaluate the long-term, 5-year outcomes . Minimally invasive esophagectomy is becoming the preferred approach because of the potential to limit surgical trauma, reduce respiratory complications, and promote earlier functional recovery. 109 Patients were randomly allocated to receive either hybrid (laparoscopy and thoracotomy) or open (laparotomy and thoracotomy) esophagectomy with an intrathoracic . Assessment and Comparison of Recovery after Open and Minimally Invasive Esophagectomy for Cancer: An Exploratory Study in Two Centers . Spotlight. In conclusion, the MIRO trial is the third randomized controlled trial for patients with esophageal cancer that shows that reducing surgical morbidity results in better postoperative outcomes. The MIRO trial suggested a trend towards a better survival after MIO 17. 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.
Background: Surgical resection is regarded as the only curative option for resectable oesophageal cancer, but pulmonary complications occurring in more than half of patients after open oesophagectomy are a great concern. Esophagectomy is a major surgical procedure associated with a significant risk of morbidity and mortality. The MIRO study was a multicenter, open-label, randomized controlled trial in which 207 patients aged 18 to 75 years who had resectable tumors in the middle or lower third of the esophagus were. 2020 Jun;271(6):1023-1029. doi . . Yibulayin W, Abulizi S, Lv H, et al. The MIRO Trial. Chirurg. Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial. Importance: Available 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. Abstract 615O_PR 'Hybrid Minimally Invasive vs. Open Esophagectomy for patients with Esophageal Cancer: Long-term outcomes of a multicentre, open-label, randomized phase III controlled trial, the MIRO trial" will be presented by Dr Guillaume Piessen during Proffered Paper Session 'Gastrointestinal tumours, non-colorectal 1' on Friday, 8 .
[Hybrid minimally invasive esophagectomy for esophageal cancer-MIRO trial]. 2021 Apr 1. Ann Surg 2020; 271: 1023-1029. A reduction in postoperative (pulmonary) complication . Background The long-term impacts of post-operative complications, especially pulmonary complications and anastomotic leakage, on health-related quality of life (HRQoL), nutritional status and body composition remain to be fully addressed in patients undergoing esophageal cancer surgery. Bonavina L, Rosman C, et al. Does it matter that lymphadenectomy through right or left side thoracotomy during esophagectomy? A major postoperative . Others are in progress, prescriptive but performed as per the surgeon's current including the MIRO trial [6] that aims to compare outcomes practice, and randomization was stratied by the surgeon as for open esophagectomy with those of a hybrid approach well as other tumor-related variables. The MIRO trial was a well-conducted surgical trial, and it was well powered with adequate accrual over a reasonable time frame. . Ann Surg 2020; 271: 1023-1029. However, a real benefit regarding oncologic safety and long-term survival is still lacking [ 3, 4, 5 ]. A retrospective review of 188 patients with esophageal cancer . In the MIRO trial, hybrid esophagectomy (HE) was compared to OTE. The results obtained by Biere et al. Source Reference: Nuytens F, et al "Five-year survival outcomes of hybrid minimally invasive esophagectomy in esophageal cancer: results of the MIRO Randomized Clinical Trial" JAMA Surg 2021; DOI . Methods Patients who underwent esophagectomy between 2015 and 2019 and survived without recurrence were . DL: Traditional invasive vs. minimally invasive esophagectomy: a multicenter, randomized trial (TIME-trial). (Enrollment in both of these trials are on-going with more information for interested patients available at clinicaltrials.gov). Esophagectomy has substantial effects upon short-term HRQOL. Both in the TIME trial and the ROBOT trial, a totally minimally invasive approach was compared to an open transthoracic esophagectomy, whereas in the MIRO trial a hybrid esophagectomy, with an open thoracic phase using thoracotomy, was compared to the open transthoracic esophagectomy (1,3,4).With only the abdominal phase performed laparoscopically in the MIRO trial . Minimally invasive oesophagectomy versus . the MIRO trial. Although multimodality therapy has been used in the treatment of esophageal cancer, there is still a poor prognosis ().For decades, esophageal resection remains the mainstream of multimodality treatment for esophageal cancer, but traditional open esophagectomy (OE) is associated with high perioperative morbidity and . Randomized Phase III Controlled Trial: The MIRO Trial Ann Surg. Inderhees S, Dubecz A. Results of a Dutch trial comparing transhiatal esophagectomy (TH) to transthoracic esophagectomy (RT) showed no overall survival benefit for RT approach compared to TH approach for patient with type II tumors (P=0.81). The MIRO trial is a recently published RCT comparing HMIE to OE. No difference in .
Middle or lower third esophageal carcinoma, junctional tumor Siewert type I Patients who underwent or not neoadjuvant chemotherapy or chemoradiation Tumor deemed to be resectable in a curative intent at the preoperative setting Age less than 75 years old, OMS status 0, 1 or 2 Patient who can undergo one or the other surgical modality Again the focus will be on short-term complications (major morbidity within 30 postoperative days) [ 28 ]. MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) Recent studies have shown that lymph node yield and surgical margins are similar and perhaps superior with MIE compared to open approaches (TIME-trial and MIRO-trial). These findings show that hybrid minimally invasive esophagectomy is an oncologically sound procedure, and reduces the incidence of major morbidity specifically pulmonary following esophagectomy for cancer. (2011). In this prospective, open-label, multicenter, randomized, controlled, phase 3 trial, we compared hybrid minimally invasive esophagectomy (laparoscopic gastric mobilization and open . 2015;39(8):1986-93. Randomization between the hybrid procedures, as performed in the recent MIRO trial 28 versus a fully minimally invasive esophagectomy as described in the TIME trial, 24 will reveal possible advantages of thoracoscopy over thoracotomy, both combined with laparoscopic gastric mobilization. Recently, the results of the French MIRO trial have been presented (not yet . The MIRO trial compared the long-term 5-year outcomes (eg, overall survival [OS], disease-free survival [DFS], and pattern of disease recurrence) of hybrid MIE (HMIE) with those of open esophagectomy in 207 patients (age range, 18-75 years; 175 men, 32 women) with resectable cancer of the middle or lower third of the esophagus. 5, 6 In the MIRO trial, the hybrid esophagectomy (HE) was compared with OTE. 156 (4):323-332 . Postoperative morbidity, in particular pulmonary complications, continues to be of great concern and occurs in more than half of patients after open oesophagectomy (OO). World J Surg 2015;39 . Randomized Phase III Controlled Trial: The MIRO Trial. 2019 Aug;90(8):677. doi . Health-related quality of life following hybrid minimally invasive versus open esophagectomy for patients with esophageal cancer. Orringer MB, Marshall B, Iannettoni MD. Funding (HealthDay)Hybrid minimally invasive esophagectomy results in lower incidence of intraoperative and postoperative major complications compared with open esophagectomy for esophageal cancer . The MIRO trial, which enrolled 207 patients with resectable cancers of the middle or lower third of the esophagus, revealed a 69% decrease in the risk of 30-day, grade II to IV postoperative morbidity with laparoscopicassisted esophagectomy compared with the conventional approach (OR 0.31; 95% CI [0.18, 0.55]; p < 0.0001) .