Clinical trial · Interventional
Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches
A Phase Ⅲ Study of Respiratory Complications Associated With Esophagectomy Through Either Ivor-Lewis or Sweet Approach for the Treatment of Middle or Lower Third Intrathoracic Esophageal Carcinoma
- 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)
Worldwide, esophageal cancer is the 6th most common cause of cancer-related death. Currently curative resection remains the cornerstone of the therapy. Despite advances in anesthesia, operative techniques and postoperative management, postoperative pulmonary complications (PPCs) occur frequently accounting for about 30% of all postoperative complications. Most importantly, PPCs have much been associated with postoperative mortality. The diaphragm is the most important respiratory muscle and its respiratory function would be inevitably damaged when esophagectomy is performed through the left posterolateral thoracotomy (Sweet procedure) because the diaphragm must be dissected for the purpose of stomach moralization. Meanwhile, Ivor-Lewis approach may effectively avoid diaphragm injury because the stomach can be managed through a laparotomy whereas an additional abdomen incision is needed. Both procedures are routinely used in practice when surgically managing esophageal cancer. The investigators hypothesize that Ivor-Lewis procedure might be superior to the left-thoracotomy route during esophagectomy in preventing PPCs.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diaphragm | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Postoperative Complications | — | UNRESOLVED | — |
| Pulmonary Function | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ivor-Lewis Esophagectomy | Procedure | — | UNRESOLVED |
| Sweet Esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ivor-Lewis
- description
- Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach
- interventionNames
- Procedure: Ivor-Lewis Esophagectomy
- type
- ACTIVE_COMPARATOR
- label
- Sweet
- description
- Esophagectomy via Left Side Thoracotomy
- interventionNames
- Procedure: Sweet Esophagectomy
Primary outcomes (1)
- measure
- morbidity of postoperative pulmonary complications
- timeFrame
- within 10 postoperative days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria: 1. Biopsy or cytology confirmed esophageal carcinoma. 2. No-contraindication to surgery. 3. Tumor locates at middle or lower thoracic esophagus (e.g. below the level of azygos vein according to AJCC cancer staging manual, esophageal and esophagogastric junctional cancer, 7th edition, 2009), so that the anastomosis could be completed within the thorax 4. Informed consent. Exclusion criteria: 1. Patients with low performance status (ECOG score \> 1) 2. Refuse to participate 3. History of adjuvant chemo and/or radiotherapy 4. History of malignancy 5. Previous abdominal and/or thoracic surgery 6. History of pleural disease with obvious pleural adhesion on X-ray examination 7. Contraindication to any of the planned intervention procedure 8. Pregnancy 9. Age of ≥ 70 years
References
Publications (0)
Data not yet available