Clinical trial · Interventional
Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer
Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer: a Multi-center, Randomized, and Open-label Trial
NCT02355249CI-TRIAL-00016780unknownPhase 3ClinicalTrials.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)
This study is a multi-center, randomized, and open-label trial to compare the safety and feasibility of traditional three incisions and minimally invasive thoracol-laparoscopic esophagectomy for esophageal cancer.
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 Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MIE | Procedure | — | UNRESOLVED |
| OE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A group (MIE)
- description
- Via minimally invasive thoracol-laparoscopic esophagectomy.
- interventionNames
- Procedure: MIE
- type
- ACTIVE_COMPARATOR
- label
- B group (OE)
- description
- Via traditional three incisions esophagectomy.
- interventionNames
- Procedure: OE
Primary outcomes (1)
- measure
- The incidence of respiratory complications
- timeFrame
- 1 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologic diagnosis of intrathoracic esophageal carcinoma of Stage I to III, which is potentially resectable judged by MDT 2. 18≤age≤75 3. cT1b-4a，N0-2，M0 confirmed by chest CT, EUS, or EUS-FNA in four weeks; 4. ECOG PS scores≤2 5. Laboratory findings in 14 days before operation：normal blood test of basic metabolism panel 6. European Clinical Oncology Group (ECOG) performance status 0,1 or 2 7. More than 12 months of expected survival 8. Tolerance of tracheal intubation and general anesthesia 9. Written informed consent Exclusion Criteria: 1. Carcinoma of the cervical esophagus or gastro-esophageal junction (GEJ) 2. Prior thoracic surgery which may effect this study 3. Pregnant or breast feeding 4. Inability to tolerance of tracheal intubation and general anesthesia 5. PS \>2 6. unstable disease 7. Poor compliance
References
Publications (1)
- DERIVEDMu J, Gao S, Mao Y, Xue Q, Yuan Z, Li N, Su K, Yang K, Lv F, Qiu B, Liu D, Chen K, Li H, Yan T, Han Y, Du M, Xu R, Wen Z, Wang W, Shi M, Xu Q, Xu S, He J. Open three-stage transthoracic oesophagectomy versus minimally invasive thoraco-laparoscopic oesophagectomy for oesophageal cancer: protocol for a multicentre prospective, open and parallel, randomised controlled trial. BMJ Open. 2015 Nov 17;5(11):e008328. doi: 10.1136/bmjopen-2015-008328. PMID 26576807