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Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial
- Source :
- BMC Cancer, BMC Cancer, BioMed Central, 2011, 11 (1), pp.310. 〈10.1186/1471-2407-11-310〉, BMC Cancer, BioMed Central, 2011, 11 (1), pp.310. ⟨10.1186/1471-2407-11-310⟩, BMC Cancer, Vol 11, Iss 1, p 310 (2011), BMC Cancer, 2011, 11 (1), pp.310. ⟨10.1186/1471-2407-11-310⟩
- Publication Year :
- 2011
- Publisher :
- HAL CCSD, 2011.
-
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)
- Subjects :
- Cancer Research
Esophageal Neoplasms
medicine.medical_treatment
Kaplan-Meier Estimate
030230 surgery
law.invention
[ SDV.CAN ] Life Sciences [q-bio]/Cancer
surgery
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Prospective Studies
Prospective cohort study
minimally invasive surgery
Standard treatment
Stomach
Middle Aged
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
3. Good health
Thoracotomy
Oncology
Esophagectomy
030220 oncology & carcinogenesis
Carcinoma, Squamous Cell
Adult
medicine.medical_specialty
oesophageal cancer
[SDV.CAN]Life Sciences [q-bio]/Cancer
Adenocarcinoma
lcsh:RC254-282
Young Adult
03 medical and health sciences
Stomach surgery
Esophagus
[SDV.CAN] Life Sciences [q-bio]/Cancer
oesophagectomy
Preoperative Care
Genetics
medicine
Humans
Aged
Postoperative Care
business.industry
General surgery
Postoperative complication
Surgery
Clinical trial
Lymph Node Excision
Laparoscopy
Lymphadenectomy
business
randomised controlled trial
Follow-Up Studies
Subjects
Details
- Language :
- English
- ISSN :
- 14712407
- Database :
- OpenAIRE
- Journal :
- BMC Cancer, BMC Cancer, BioMed Central, 2011, 11 (1), pp.310. 〈10.1186/1471-2407-11-310〉, BMC Cancer, BioMed Central, 2011, 11 (1), pp.310. ⟨10.1186/1471-2407-11-310⟩, BMC Cancer, Vol 11, Iss 1, p 310 (2011), BMC Cancer, 2011, 11 (1), pp.310. ⟨10.1186/1471-2407-11-310⟩
- Accession number :
- edsair.doi.dedup.....51bbfb4effbd70f6ca4865c19379b31b