Clinical trial · Interventional
Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer
Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study
NCT00063986CI-TRIAL-00067681completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery. PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I, stage II, or stage III 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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimally invasive esophagectomy (MIE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Minimally invasive esophagectomy (MIE)
- description
- Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
- interventionNames
- Procedure: Minimally invasive esophagectomy (MIE)
Primary outcomes (1)
- measure
- Peri-operative Mortality at 30 Days
- timeFrame
- Assessed at 30 days from surgery
- description
- The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.
Secondary outcomes (8)
- measure
- Rate of Conversion to Open Operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: DISEASE CHARACTERISTICS: * High grade dysplasia of the esophagus who would undergo esophagectomy OR esophageal cancer at stage T1-T3, N0-N1 who require esophagectomy (patients with M1 disease and/or bulky lymph node involvement were excluded). * Pathological confirmation of a diagnosis of cancer or high-grade dysplasia of the esophagus by biopsy. * Computerized tomography (CT) scan of chest and abdomen within 6 weeks prior to registration * Stomach must be available for conduit * Age of 18 and over * ECOG performance status of 0-2 * Creatinine less than 2 mg/dL * Patients with esophageal cancer who would be treated with neoadjuvant chemotherapy and/or radiation were eligible. If patients were registered prior to receiving neoadjuvant chemotherapy they were allowed up to 5 months to complete therapy and any restaging that was necessary before operation was performed. * The patient was considered an appropriate candidate for surgery based on preoperative clinical staging and physiological factors prior to registration as documented in the surgical plan. Pre-operative staging should include: * Endoscopic ultrasound (EUS) * Positron emission tomography (PET) scan and/or laparoscopic staging (Laparoscopic staging could be performed on the day of resection. Additional evaluation was recommended if the PET scan suggested distant metastatic disease.) EXCLUSION CRITERIA: * Cancer extending into the stomach more than 20% * Prior anti-reflux or gastric operations * Prior right thoracotomy * Prior major neck operation other than the removal of superficial skin lesion
References
Publications (0)
Data not yet available
No reference posted for this study.