Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer
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| ClinicalTrials.gov Identifier: NCT00063986 |
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Recruitment Status :
Completed
First Posted : July 9, 2003
Results First Posted : February 11, 2013
Last Update Posted : February 12, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Cancer | Procedure: Minimally invasive esophagectomy (MIE) | Phase 2 |
OBJECTIVES:
- Determine the feasibility of performing minimally invasive esophagectomy (MIE), in terms of 30-day mortality, in patients with high-grade dysplasia of the esophagus or stage I-III esophageal cancer.
- Determine the complications associated with this procedure in these patients.
- Determine the rate at which conversion to open operation is required in patients undergoing this procedure.
- Determine the length of the operation, duration of intensive care unit stay, and length of hospital stay in patients undergoing this procedure.
- Determine feasibility and conversion rate of MIE after neoadjuvant therapy.
- Assess the effectiveness of lymph node dissection by MIE by recording the total number of lymph nodes dissected.
- Assess outcomes at follow-up to three years.
OUTLINE: This is a multicenter study.
Patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus. Mortality at 30 days is assessed.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
ACTUAL ACCRUAL: A total of 110 patients were accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study |
| Study Start Date : | March 2004 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | August 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Minimally invasive esophagectomy (MIE)
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.
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Procedure: Minimally invasive esophagectomy (MIE)
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. |
- Peri-operative Mortality at 30 Days [ Time Frame: Assessed at 30 days from surgery ]The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.
- Rate of Conversion to Open Operation [ Time Frame: Assessed at surgery ]Proportion of patients who required conversion to operation will be reported.
- Duration of Operating Time [ Time Frame: Assessed at surgery ]The length of the operation (total of thoracic and abdominal components) is recorded.
- Duration of Intensive Care Stay [ Time Frame: Assessed after surgery until patients are out of intensive care ]Number of post-operative days in intensive care is reported.
- Overall Length of Hospital Stay [ Time Frame: Assessed after surgery until patients are out of hospital ]The number of days patients stayed in the hospital after surgery is reported.
- Total Number of Lymph Nodes Dissected [ Time Frame: Assessed at surgery ]The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.
- 3-year Survival Rate [ Time Frame: Assessed at 3 years ]Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.
- 30-day Peri-operative Mortality After Neoadjuvant Therapy [ Time Frame: Assessed at 30 days after surgery ]Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.
- Rate of Conversion to Open Operation After Neoadjuvant Therapy [ Time Frame: Assessed at surgery ]Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063986
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| Study Chair: | James D. Luketich, MD | University of Pittsburgh |
| Responsible Party: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00063986 |
| Other Study ID Numbers: |
CDR0000305866 U10CA021115 ( U.S. NIH Grant/Contract ) E2202 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) ) |
| First Posted: | July 9, 2003 Key Record Dates |
| Results First Posted: | February 11, 2013 |
| Last Update Posted: | February 12, 2013 |
| Last Verified: | February 2013 |
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esophageal cancer minimally invasive esophagectomy (MIE) |
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Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |