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

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          Abstract

          Background

          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.

          Methods/Design

          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.

          Discussion

          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.

          Trial Registration

          NCT00937456 (ClinicalTrials.gov)

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          Most cited references 17

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          Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the esophagus.

          Controversy exists about the best surgical treatment for esophageal carcinoma. We randomly assigned 220 patients with adenocarcinoma of the mid-to-distal esophagus or adenocarcinoma of the gastric cardia involving the distal esophagus either to transhiatal esophagectomy or to transthoracic esophagectomy with extended en bloc lymphadenectomy. Principal end points were overall survival and disease-free survival. Early morbidity and mortality, the number of quality-adjusted life-years gained, and cost effectiveness were also determined. A total of 106 patients were assigned to undergo transhiatal esophagectomy, and 114 to undergo transthoracic esophagectomy. Demographic characteristics and characteristics of the tumor were similar in the two groups. Perioperative morbidity was higher after transthoracic esophagectomy, but there was no significant difference in in-hospital mortality (P=0.45). After a median follow-up of 4.7 years, 142 patients had died--74 (70 percent) after transhiatal resection and 68 (60 percent) after transthoracic resection (P=0.12). Although the difference in survival was not statistically significant, there was a trend toward a survival benefit with the extended approach at five years: disease-free survival was 27 percent in the transhiatal-esophagectomy group, as compared with 39 percent in the transthoracic-esophagectomy group (95 percent confidence interval for the difference, -1 to 24 percent [the negative value indicates better survival with transhiatal resection]), whereas overall survival was 29 percent as compared with 39 percent (95 percent confidence interval for the difference, -3 to 23 percent). Transhiatal esophagectomy was associated with lower morbidity than transthoracic esophagectomy with extended en bloc lymphadenectomy. Although median overall, disease-free, and quality-adjusted survival did not differ statistically between the groups, there was a trend toward improved long-term survival at five years with the extended transthoracic approach. Copyright 2002 Massachusetts Medical Society
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            Proposed classification of complications of surgery with examples of utility in cholecystectomy.

            Lack of uniform reporting of negative outcomes makes interpretation of surgical literature difficult. We attempt to define and classify negative outcomes by differentiating complications, sequelae, and failures. Complications and sequelae result from procedures, adding new problems to the underlying disease. However, complications are unexpected events not intrinsic to the procedure, whereas sequelae are inherent to the procedure. Failures are events in which the purpose of the procedure is not fulfilled. We propose a classification of complications based on four grades: Grade I complications are alterations from the ideal postoperative course, non-life-threatening, and with no lasting disability. Complications of this grade necessitate only bedside procedures and do not significantly extend hospital stay. Grade II complications are potentially life-threatening but without residual disability. Within grade II complications a subdivision is made according to the requirement for invasive procedures. Grade III complications are those with residual disability, including organ resection or persistence of life-threatening conditions. Finally, grade IV complications are deaths as a result of complications. To illustrate the relevance of the classification, we reviewed 650 cases of elective cholecystectomy. Risk factors for development of complications were determined, and the classification was also used to analyze the value of a modified APACHE II as a preoperative prognostic score. Both supported the relevance of the proposed classification. The advantages of such a classification are (1) increased uniformity in reporting results, (2) the ability to compare results of two distinct time periods in a single center, (3) the ability to compare results of surgery between different centers, (4) the ability to compare results of surgical versus nonsurgical measures, (5) the ability to perform adequate metaanalysis, (6) the ability to identify objective preoperative risk factors, and (7) the ability to establish preoperative prognostic scores.
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              Comparison of the outcomes between open and minimally invasive esophagectomy.

              We report patient outcomes from esophageal resection with respect to morbidity and cancer survival comparing open thoracotomy and laparotomy (Open), with a thoracoscopic/laparotomy approach (Thoracoscopic-Assisted) and a total thoracoscopic/laparoscopic approach (Total MIE). From a prospective database of all patients managed with cancer of the esophagus or esophagogastric junction, patients who had a resection using one of three techniques were analyzed to assess postoperative variables, adequacy of cancer clearance, and survival. The number of patients for each procedure was as follows: Open, 114; Thoracoscopic-Assisted, 309; and Total MIE, 23. The groups were comparable with respect to preoperative variables. The differences in the postoperative variables were: less median blood loss in the Thoracoscopic-Assisted (400 mL) and Total MIE (300 mL) groups versus Open (600 mL); longer time for Total MIE (330 minutes) versus Thoracoscopic-Assisted (285 minutes) and Open (300 minutes); longer median time in hospital for Open (14 days) versus Thoracoscopic-Assisted (13 days), Total MIE (11 days) and less stricture formation in the Open (6.1%) versus Thoracoscopic-Assisted (21.6%), Total MIE (36%). There were no differences in lymph node retrieval for each of the approaches. Open had more stage III patients (65.8%) versus Thoracoscopic-Assisted (34.4%), Total MIE (52.1%). There was no difference in survival when the groups were compared stage for stage for overall median or 3-year survival. Minimally invasive techniques to resect the esophagus in patients with cancer were confirmed to be safe and comparable to an open approach with respect to postoperative recovery and cancer survival.
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                Author and article information

                Journal
                BMC Cancer
                BMC Cancer
                BioMed Central
                1471-2407
                2011
                23 July 2011
                : 11
                : 310
                Affiliations
                [1 ]Department of Digestive and Oncological Surgery, University Hospital, Place de Verdun, Lille, F-59037, France
                [2 ]Faculty of Medicine Henri Warembourg, University of Lille 2, Lille, F-59045, France
                [3 ]Biostatistic and Epidemiological Unit, EA 4184, Centre Georges François Leclerc, 1 rue du Pr Marion, Dijon, F-21079, France
                [4 ]Department of Digestive Surgery, University Hospital, Avenue Molière, Strasbourg, F-67200, France
                [5 ]Department of Digestive Surgery, Purpan University Hospital, Place du Dr Baylac, Toulouse, F-31059, France
                [6 ]Department of Digestive Surgery, Pessac University Hospital, Avenue de Magellan Bordeaux, F-33604, France
                [7 ]Department of Digestive Surgery, Nord University Hospital, Chemin des Bourrely, Marseille, F-13915, France
                [8 ]Department of Digestive Surgery, University Hospital, Boulevard Montalembert, Clermont-Ferrand, F-63003, France
                [9 ]Department of Digestive Surgery, Croix-Rousse University Hospital, Grande Rue de la Croix Rousse, Lyon, F-69004, France
                [10 ]Department of Digestive Surgery, Pontchaillou University Hospital, Rue Henri Le Guilloux, Rennes, F-35033, France
                [11 ]Department of Digestive Surgery, Louis Mourrier University Hospital, Rue des Renouillers, Colombes, F-92701, France
                [12 ]Department of Digestive Surgery, Institut Mutualiste Montsouris, Boulevard Jourdan, Paris, F-75014, France
                [13 ]Department of Digestive Surgery, Ambroise Paré University Hospital, Boulevard Charles de Gaulle, Boulogne Billancourt, F-92104, France
                [14 ]Department of Digestive Surgery, University Hospital, Place du Pr Robert Debré, Nîmes, F-30029, France
                Article
                1471-2407-11-310
                10.1186/1471-2407-11-310
                3156811
                21781337
                Copyright ©2011 Briez et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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