Trial Outcomes & Findings for Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer (NCT NCT00063986)

NCT ID: NCT00063986

Last Updated: 2023-06-29

Results Overview

The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 110 participants
• Primary outcome timeframe: Assessed at 30 days from surgery
• Results posted on: 2023-06-29

Participant Flow

This study was activated on March 3, 2004, accrued its first patient on June 24, 2004, and closed on August 15, 2008. A total of 110 patients were accrued for this study.

Participant milestones

Measure	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. Only eligible and treated patients are included in the primary analysis.
Overall Study STARTED	110
Overall Study Treated	105
Overall Study Eligible and Treated	104
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	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. Only eligible and treated patients are included in the primary analysis.
Overall Study Withdrawal by Subject	1
Overall Study Ineligible	1
Overall Study Intra-operatively ineligible	4

Baseline Characteristics

Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer

Baseline characteristics by cohort

Measure	Minimally Invasive Esophagectomy (MIE) n=104 Participants 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. Only eligible and treated patients are included in the primary analysis.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants
Region of Enrollment United States	104 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at 30 days from surgery

Population: Eligible and treated patients are included in this analysis.

The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.

Outcome measures

Measure	Minimally Invasive Esophagectomy (MIE) n=104 Participants 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. Only eligible and treated patients are included in the primary analysis.
Peri-operative Mortality at 30 Days	0.029 proportion of participants Interval 0.008 to 0.073

SECONDARY outcome

Timeframe: Assessed at surgery

Population: Eligible and treated patients are included in this analysis.

Proportion of patients who required conversion to operation will be reported.

Outcome measures

Measure	Minimally Invasive Esophagectomy (MIE) n=104 Participants 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. Only eligible and treated patients are included in the primary analysis.
Rate of Conversion to Open Operation	0.087 Proportion of patients Interval 0.004 to 0.158

SECONDARY outcome

Timeframe: Assessed at surgery

Population: Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, 10 patients' length of operation data were unavailable, so the results are based on data from 94 patients.

The length of the operation (total of thoracic and abdominal components) is recorded.

Outcome measures

Measure	Minimally Invasive Esophagectomy (MIE) n=94 Participants 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. Only eligible and treated patients are included in the primary analysis.
Duration of Operating Time	330 Minutes Interval 120.0 to 813.0

SECONDARY outcome

Timeframe: Assessed after surgery until patients are out of intensive care

Population: Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of intensive care stay is missing for 3 patients, so the results are based on data from 101 patients.

Number of post-operative days in intensive care is reported.

Outcome measures

Measure	Minimally Invasive Esophagectomy (MIE) n=101 Participants 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. Only eligible and treated patients are included in the primary analysis.
Duration of Intensive Care Stay	2 Days Interval 0.0 to 39.0

SECONDARY outcome

Timeframe: Assessed after surgery until patients are out of hospital

Population: Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of hospital stay is missing for 3 patients, so the results are based on data from 101 patients.

The number of days patients stayed in the hospital after surgery is reported.

Outcome measures

Measure	Minimally Invasive Esophagectomy (MIE) n=101 Participants 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. Only eligible and treated patients are included in the primary analysis.
Overall Length of Hospital Stay	9 Days Interval 4.0 to 138.0

SECONDARY outcome

Timeframe: Assessed at surgery

Population: Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, the number of lymph nodes removed is missing for 1 patient, so the results are based on data from 103 patients.

The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.

Outcome measures

Measure	Minimally Invasive Esophagectomy (MIE) n=103 Participants 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. Only eligible and treated patients are included in the primary analysis.
Total Number of Lymph Nodes Dissected	19 Lymph nodes Interval 2.0 to 55.0

SECONDARY outcome

Timeframe: Assessed at 3 years

Population: Eligible and treated patients are included in this analysis.

Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.

Outcome measures

Measure	Minimally Invasive Esophagectomy (MIE) n=104 Participants 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. Only eligible and treated patients are included in the primary analysis.
3-year Survival Rate	0.584 proportion of participants Interval 0.477 to 0.676

SECONDARY outcome

Timeframe: Assessed at 30 days after surgery

Population: 35 eligible and treated patients with neoadjuvant therapy are included in this analysis.

Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.

Outcome measures

Measure	Minimally Invasive Esophagectomy (MIE) n=35 Participants 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. Only eligible and treated patients are included in the primary analysis.
30-day Peri-operative Mortality After Neoadjuvant Therapy	0.057 Proportion of patients Interval 0.01 to 0.169

SECONDARY outcome

Timeframe: Assessed at surgery

Population: 35 eligible and treated patients with neoadjuvant therapy are included in this analysis.

Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.

Outcome measures

Measure	Minimally Invasive Esophagectomy (MIE) n=35 Participants 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. Only eligible and treated patients are included in the primary analysis.
Rate of Conversion to Open Operation After Neoadjuvant Therapy	0.086 Proportion of patients Interval 0.018 to 0.231

Adverse Events

Minimally Invasive Esophagectomy (MIE)

Serious events: 75 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Measure	Minimally Invasive Esophagectomy (MIE) n=105 participants at risk 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. Only eligible and treated patients are included in the primary analysis.
Blood and lymphatic system disorders Anemia	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Investigations Lymphopenia	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Cardiac disorders Atrial fibrillation	2.9% 3/105 • Assessed during surgery and for 30 days after the end of treatment.
Cardiac disorders Cardiac-ischemia	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Vascular disorders Hypotension	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Cardiac disorders Left ventricular systolic dysfunction	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Cardiac disorders Cardiac-other	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Psychiatric disorders Insomnia	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Investigations Weight gain	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Investigations Weight loss	4.8% 5/105 • Assessed during surgery and for 30 days after the end of treatment.
General disorders Constitutional, other	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Investigations PTT	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Injury, poisoning and procedural complications Wound - non-infectious	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
General disorders Death NOS	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
General disorders Death - multiorgan failure	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Anorexia	6.7% 7/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Dehydration	2.9% 3/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Dysphagia	18.1% 19/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Fistula, Colon/cecum/appendix	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Fistula, Esophageal	3.8% 4/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Ileus	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Injury, poisoning and procedural complications Leak (including anastomotic, esophagitis)	9.5% 10/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	2.9% 3/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Obstruction, small bowel NOS	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Obstruction, stomach	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Stenosis (including anastomotic) esophagus	25.7% 27/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Vomiting	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders GI-other	5.7% 6/105 • Assessed during surgery and for 30 days after the end of treatment.
Vascular disorders Hematoma	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Upper GI, hemorrhage NOS	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Injury, poisoning and procedural complications Surgical hemorrhage	2.9% 3/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Colitis, infectious (e.g. C.diff)	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ Gr0-2 neutropenia, jejunum	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ Gr0-2 neutropenia, lung	7.6% 8/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ Gr0-2 neutropenia, mediastinm	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ Gr0-2 neutropenia, neck NOS	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ Gr0-2 neutropenia, pleura	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ Gr0-2 neutropenia, upper airway	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infectionw/ Gr0-2 neutropenia, wound	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ unknown ANC foreign body	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ unknown ANC lung	3.8% 4/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ unknown ANC peritoneal cavity	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ unknown ANC pleura (empyema)	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ unknown ANC upper aerodigest	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Opportunistic infection lymphopenia>=grade 1	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Infections and infestations Infection w/ Gr0-2 neutropenia, blood	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Vascular disorders Chyle or lymph leakage	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
General disorders Edema limb	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
General disorders Edema trunk/genital	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Acidosis	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Investigations ALT increased	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Investigations AST increased	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyperglycemia	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypoglycemia	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypophosphatemia	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyperkalemia	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypokalemia	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyponatremia	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Joint effusion	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Nervous system disorders CNS cerebrovascular ischemia	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Psychiatric disorders Confusion	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Nervous system disorders Laryngeal nerve dysfunction	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Psychiatric disorders Agitation	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Psychiatric disorders Anxiety	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Psychiatric disorders Depression	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Nervous system disorders Depressed level of consciousness	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Nervous system disorders Syncope	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Abdomen, pain	2.9% 3/105 • Assessed during surgery and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Chest wall, pain	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Esophagus, pain	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
General disorders Pain NOS	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
General disorders Pleura, pain	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
General disorders Pain-other	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome (ARDS)	5.7% 6/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	5.7% 6/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 4/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Fistula trachea	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 7/105 • Assessed during surgery and for 30 days after the end of treatment.
Injury, poisoning and procedural complications Obstruction, airway-larynx	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	13.3% 14/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	4.8% 5/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Injury, poisoning and procedural complications Prolong intubation post pulm resection	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	1.9% 2/105 • Assessed during surgery and for 30 days after the end of treatment.
Injury, poisoning and procedural complications Intra-op injury Spleen	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Injury, poisoning and procedural complications Intra-op injury Vein inferior vena cava	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Injury, poisoning and procedural complications Vascular access,Thrombosis/embolism	0.95% 1/105 • Assessed during surgery and for 30 days after the end of treatment.
Vascular disorders Thrombosis/thrombus/embolism	8.6% 9/105 • Assessed during surgery and for 30 days after the end of treatment.

Other adverse events

Measure	Minimally Invasive Esophagectomy (MIE) n=105 participants at risk 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. Only eligible and treated patients are included in the primary analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	26.7% 28/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	11.4% 12/105 • Assessed during surgery and for 30 days after the end of treatment.
Blood and lymphatic system disorders Anemia	10.5% 11/105 • Assessed during surgery and for 30 days after the end of treatment.
Cardiac disorders Atrial fibrillation	13.3% 14/105 • Assessed during surgery and for 30 days after the end of treatment.
Gastrointestinal disorders Dysphagia	10.5% 11/105 • Assessed during surgery and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	6.7% 7/105 • Assessed during surgery and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	6.7% 7/105 • Assessed during surgery and for 30 days after the end of treatment.

Additional Information

Study Statistician

ECOG Statistical Office

Phone: 617-632-3012

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place