Clinical trial · Interventional
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial
NCT00937456CI-TRIAL-00109010completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopically-assisted esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopically-assisted esophagectomy
- description
- Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
- interventionNames
- Procedure: Laparoscopically-assisted esophagectomy
- type
- ACTIVE_COMPARATOR
- label
- Open esophagectomy
- description
- Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)
- interventionNames
- Procedure: Laparoscopically-assisted esophagectomy
Primary outcomes (1)
- measure
- To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Squamous cell or adenocarcinoma of the thoracic esophagus T1, T2, T3, N0-N1, M0, before any treatment * 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 * Written informed consent form * Possible follow-up Exclusion Criteria: 1. General criteria: PO2 ≤ 60 mmHg; PCO2 \> 45 mmHg; FEV ≤ 1000 ml/sec * Hepatic cirrhosis * Recent myocardial infarction (in the previous 6 months) or progressive coronary disease * Distal arteritis (Leriche-Fontaine stage II upwards) * Concomitant cancer, other than subcarinal esophageal cancer 2. Disease-related factors * Invasion of subclavicular lymph nodes in a clinical examination or on biospy * Lymph nodes near the origin of the celiac artery with a diameter ≥ 1 cm on CT or that appear to be suspect on endoscopic ultrasound (to differentiate them from the paracardial or left gastric lymph nodes, which does not constitute an exclusion criterion) * Recurrent nerve palsy * Evidence of extension to the tracheobronchial tree * Signs of mediastinal invasion (vertebral contact, aortic contact ≥ 90°, or invasion of nonresectable neighboring organs such as the aorta, trachea, main bronchi, etc.) * Distant metastasis 3. Laparoscopy-related factors * Patient presenting a general contraindication to laparoscopy * A history of median or subcostal laparotomy
References
Publications (3)
- BACKGROUNDNuytens 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. PMID 33595631
- BACKGROUNDBriez 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. PMID 21781337
- RESULTMariette 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. PMID 30625052