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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC 2008/1907 | Other Identifier | DHOS | |
| 2009-A00144-53. | Other Identifier | ID-RCB number, ANSM |
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To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopically-assisted esophagectomy | Experimental | Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual. |
|
| Open esophagectomy | Active Comparator | Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopically-assisted esophagectomy | Procedure | To compare during the abdominal approach the laparoscopic route to the open route for gastric mobilization. Thoracic approach will be the same between the 2 arms through thoracotomy with extended two field lymphadenectomy |
| Measure | Description | Time Frame |
|---|---|---|
| To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| overall morbidity | 30 days | |
| disease free survival | 2 years | |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
General criteria: PO2 ≤ 60 mmHg; PCO2 > 45 mmHg; FEV ≤ 1000 ml/sec
Disease-related factors
Laparoscopy-related factors
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Mariette, MD, PhD | University Hospital of Lille, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Du Haut Leveque | Bordeaux | 33604 | France | |||
| Hopital Ambroise Pare Ap-Hp |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33595631 | Background | Nuytens F, Dabakuyo-Yonli TS, Meunier B, Gagniere J, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrere N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Markar SR, Piessen G; Federation de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Groups. Five-Year Survival Outcomes of Hybrid Minimally Invasive Esophagectomy in Esophageal Cancer: Results of the MIRO Randomized Clinical Trial. JAMA Surg. 2021 Apr 1;156(4):323-332. doi: 10.1001/jamasurg.2020.7081. | |
| 21781337 |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| 2 years |
| quality of life | 2 years |
| economical interest of the surgical technique apprehended through a hospital point of view | 6 months |
| Boulogne-Billancourt |
| 92 100 |
| France |
| Hotel Dieu | Clermont-Ferrand | 63 058 | France |
| Hopital Louis Mourier | Colombes | 92 701 | France |
| Hopital de La Croix Rousse | Lyon | 69 317 | France |
| Hopital St Marguerite Ap-Hm | Marseille | 13 274 | France |
| Hopital St Louis Ap-Hp | Paris | 75 010 | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| Hopitalpontchaillou | Rennes | 35 033 | France |
| Hopitaux Universitaires de Strasbourg | Strasbourg | 67 098 | France |
| Hopital Purpan | Toulouse | 31 059 | France |
| Background |
| Briez N, Piessen G, Bonnetain F, Brigand C, Carrere N, Collet D, Doddoli C, Flamein R, Mabrut JY, Meunier B, Msika S, Perniceni T, Peschaud F, Prudhomme M, Triboulet JP, Mariette C. Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial. BMC Cancer. 2011 Jul 23;11:310. doi: 10.1186/1471-2407-11-310. |
| 30625052 | Result | Mariette C, Markar SR, Dabakuyo-Yonli TS, Meunier B, Pezet D, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrere N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Bonnetain F, Piessen G; Federation de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Group. Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer. N Engl J Med. 2019 Jan 10;380(2):152-162. doi: 10.1056/NEJMoa1805101. |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |