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

• Sponsor: Eastern Cooperative Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00063986
• Collaborator: National Cancer Institute (NCI) (NIH), Cancer and Leukemia Group B (Other)
• Enrollment: 110
• Locations: 41
• Arm: 1
• Duration (Months): 101
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Detailed Description

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 Design

• Study Type: Interventional
• 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: Mar 1, 2004
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Outcome Measures

Primary Outcome Measures

1. Peri-operative Mortality at 30 Days [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.

Secondary Outcome Measures

1. Rate of Conversion to Open Operation [Assessed at surgery]

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

2. Duration of Operating Time [Assessed at surgery]

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

3. Duration of Intensive Care Stay [Assessed after surgery until patients are out of intensive care]

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

4. Overall Length of Hospital Stay [Assessed after surgery until patients are out of hospital]

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

5. Total Number of Lymph Nodes Dissected [Assessed at surgery]

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

6. 3-year Survival Rate [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.

7. 30-day Peri-operative Mortality After Neoadjuvant Therapy [Assessed at 30 days after surgery]

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

8. Rate of Conversion to Open Operation After Neoadjuvant Therapy [Assessed at surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California	United States	92868
2	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
3	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
4	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
5	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
6	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
7	Meeker County Memorial Hospital	Lichfield	Minnesota	United States	55355
8	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
9	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota	United States	55407
10	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
11	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455
12	HealthEast Cancer Care at St. Joseph's Hospital	Saint Paul	Minnesota	United States	55102
13	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota	United States	55379
14	Regions Hospital Cancer Care Center	St. Paul	Minnesota	United States	55101
15	HealthEast Cancer Care at Woodwinds Health Campus	Woodbury	Minnesota	United States	55125
16	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
17	Immanuel Medical Center	Omaha	Nebraska	United States	68122
18	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
19	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
20	Mount Sinai Medical Center	New York	New York	United States	10029
21	Mary Rutan Hospital	Bellefontaine	Ohio	United States	43311
22	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
23	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio	United States	43210-1240
24	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
25	CCOP - Columbus	Columbus	Ohio	United States	43215
26	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
27	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
28	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
29	Grady Memorial Hospital	Delaware	Ohio	United States	43015
30	Fairfield Medical Center	Lancaster	Ohio	United States	43130
31	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
32	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
33	Mercy Medical Center	Springfield	Ohio	United States	45504
34	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
35	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
36	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
37	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
38	UPMC Cancer Centers	Pittsburgh	Pennsylvania	United States	15232
39	Geisinger Medical Group - Scenery Park	State College	Pennsylvania	United States	16801
40	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
41	Medical City Dallas Hospital	Dallas	Texas	United States	75230

Sponsors and Collaborators

• Eastern Cooperative Oncology Group
• National Cancer Institute (NCI)
• Cancer and Leukemia Group B

Investigators

• Study Chair: James D. Luketich, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eastern Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT00063986
• Other Study ID Numbers: CDR0000305866; U10CA021115; E2202
• First Posted: Jul 9, 2003
• Last Update Posted: Feb 12, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Eastern Cooperative Oncology Group: esophageal cancer; minimally invasive esophagectomy (MIE)
• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

Participant Flow

Recruitment Details	This study was activated on March 3, 2004 and closed on August 15, 2008. A total of 110 patients were accrued for this study.

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Period Title: Overall Study
STARTED	110
Treated	105
Eligible and Treated	104
COMPLETED	104
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Overall Participants	104
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	65
Sex: Female, Male (Count of Participants)
Female	21 20.2%
Male	83 79.8%
Region of Enrollment (participants) [Number]
United States	104 100%

Outcome Measures

1. Primary Outcome

Title	Peri-operative Mortality at 30 Days
Description	The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.
Time Frame	Assessed at 30 days from surgery

Outcome Measure Data

Analysis Population Description

Eligible and treated patients are included in this analysis.

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Measure Participants	104
Number (90% Confidence Interval) [proportion of participants]	0.029 0%

2. Secondary Outcome

Title	Rate of Conversion to Open Operation
Description	Proportion of patients who required conversion to operation will be reported.
Time Frame	Assessed at surgery

Outcome Measure Data

Analysis Population Description

Eligible and treated patients are included in this analysis.

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Measure Participants	104
Number (95% Confidence Interval) [Proportion of patients]	0.087

3. Secondary Outcome

Title	Duration of Operating Time
Description	The length of the operation (total of thoracic and abdominal components) is recorded.
Time Frame	Assessed at surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Measure Participants	94
Median (Full Range) [Minutes]	330

4. Secondary Outcome

Title	Duration of Intensive Care Stay
Description	Number of post-operative days in intensive care is reported.
Time Frame	Assessed after surgery until patients are out of intensive care

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Measure Participants	101
Median (Full Range) [Days]	2

5. Secondary Outcome

Title	Overall Length of Hospital Stay
Description	The number of days patients stayed in the hospital after surgery is reported.
Time Frame	Assessed after surgery until patients are out of hospital

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Measure Participants	101
Median (Full Range) [Days]	9

6. Secondary Outcome

Title	Total Number of Lymph Nodes Dissected
Description	The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.
Time Frame	Assessed at surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Measure Participants	103
Median (Full Range) [Lymph nodes]	19

7. Secondary Outcome

Title	3-year Survival Rate
Description	Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.
Time Frame	Assessed at 3 years

Outcome Measure Data

Analysis Population Description

Eligible and treated patients are included in this analysis.

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Measure Participants	104
Number (95% Confidence Interval) [proportion of participants]	0.584 0.6%

8. Secondary Outcome

Title	30-day Peri-operative Mortality After Neoadjuvant Therapy
Description	Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.
Time Frame	Assessed at 30 days after surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Measure Participants	35
Number (90% Confidence Interval) [Proportion of patients]	0.057

9. Secondary Outcome

Title	Rate of Conversion to Open Operation After Neoadjuvant Therapy
Description	Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.
Time Frame	Assessed at surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
Measure Participants	35
Number (95% Confidence Interval) [Proportion of patients]	0.086

Adverse Events

Time Frame	Assessed during surgery and for 30 days after the end of treatment.
Arm/Group Title	Minimally Invasive Esophagectomy (MIE)
Arm/Group 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. Only eligible and treated patients are included in the primary analysis.
All Cause Mortality
	Minimally Invasive Esophagectomy (MIE)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Minimally Invasive Esophagectomy (MIE)
	Affected / at Risk (%)	# Events
Total	75/105 (71.4%)
Blood and lymphatic system disorders
Anemia	2/105 (1.9%)
Cardiac disorders
Atrial fibrillation	3/105 (2.9%)
Cardiac-ischemia	1/105 (1%)
Left ventricular systolic dysfunction	1/105 (1%)
Cardiac-other	1/105 (1%)
Gastrointestinal disorders
Dysphagia	19/105 (18.1%)
Fistula, Colon/cecum/appendix	1/105 (1%)
Fistula, Esophageal	4/105 (3.8%)
Ileus	1/105 (1%)
Nausea	3/105 (2.9%)
Obstruction, small bowel NOS	1/105 (1%)
Obstruction, stomach	1/105 (1%)
Stenosis (including anastomotic) esophagus	27/105 (25.7%)
Vomiting	2/105 (1.9%)
GI-other	6/105 (5.7%)
Upper GI, hemorrhage NOS	1/105 (1%)
Abdomen, pain	3/105 (2.9%)
Esophagus, pain	1/105 (1%)
General disorders
Constitutional, other	1/105 (1%)
Death NOS	1/105 (1%)
Death - multiorgan failure	1/105 (1%)
Edema limb	1/105 (1%)
Edema trunk/genital	1/105 (1%)
Pain NOS	1/105 (1%)
Pleura, pain	2/105 (1.9%)
Pain-other	2/105 (1.9%)
Infections and infestations
Colitis, infectious (e.g. C.diff)	1/105 (1%)
Infection w/ Gr0-2 neutropenia, jejunum	1/105 (1%)
Infection w/ Gr0-2 neutropenia, lung	8/105 (7.6%)
Infection w/ Gr0-2 neutropenia, mediastinm	1/105 (1%)
Infection w/ Gr0-2 neutropenia, neck NOS	1/105 (1%)
Infection w/ Gr0-2 neutropenia, pleura	2/105 (1.9%)
Infection w/ Gr0-2 neutropenia, upper airway	1/105 (1%)
Infectionw/ Gr0-2 neutropenia, wound	2/105 (1.9%)
Infection w/ unknown ANC foreign body	1/105 (1%)
Infection w/ unknown ANC lung	4/105 (3.8%)
Infection w/ unknown ANC peritoneal cavity	1/105 (1%)
Infection w/ unknown ANC pleura (empyema)	1/105 (1%)
Infection w/ unknown ANC upper aerodigest	1/105 (1%)
Opportunistic infection lymphopenia>=grade 1	1/105 (1%)
Infection w/ Gr0-2 neutropenia, blood	1/105 (1%)
Injury, poisoning and procedural complications
Wound - non-infectious	1/105 (1%)
Leak (including anastomotic, esophagitis)	10/105 (9.5%)
Surgical hemorrhage	3/105 (2.9%)
Obstruction, airway-larynx	1/105 (1%)
Prolong intubation post pulm resection	1/105 (1%)
Intra-op injury Spleen	1/105 (1%)
Intra-op injury Vein inferior vena cava	1/105 (1%)
Vascular access,Thrombosis/embolism	1/105 (1%)
Investigations
Lymphopenia	1/105 (1%)
Weight gain	1/105 (1%)
Weight loss	5/105 (4.8%)
PTT	1/105 (1%)
ALT increased	1/105 (1%)
AST increased	1/105 (1%)
Metabolism and nutrition disorders
Anorexia	7/105 (6.7%)
Dehydration	3/105 (2.9%)
Acidosis	1/105 (1%)
Hypoalbuminemia	2/105 (1.9%)
Hyperglycemia	1/105 (1%)
Hypoglycemia	1/105 (1%)
Hypophosphatemia	2/105 (1.9%)
Hyperkalemia	1/105 (1%)
Hypokalemia	2/105 (1.9%)
Hyponatremia	1/105 (1%)
Musculoskeletal and connective tissue disorders
Joint effusion	1/105 (1%)
Nonneuropathic generalized weakness	1/105 (1%)
Chest wall, pain	2/105 (1.9%)
Nervous system disorders
CNS cerebrovascular ischemia	1/105 (1%)
Laryngeal nerve dysfunction	1/105 (1%)
Depressed level of consciousness	1/105 (1%)
Syncope	1/105 (1%)
Psychiatric disorders
Insomnia	1/105 (1%)
Confusion	2/105 (1.9%)
Agitation	1/105 (1%)
Anxiety	1/105 (1%)
Depression	2/105 (1.9%)
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension	1/105 (1%)
Adult Respiratory Distress Syndrome (ARDS)	6/105 (5.7%)
Aspiration	6/105 (5.7%)
Atelectasis	1/105 (1%)
Chylothorax	1/105 (1%)
Cough	1/105 (1%)
Dyspnea	4/105 (3.8%)
Fistula trachea	1/105 (1%)
Hypoxia	7/105 (6.7%)
Pleural effusion (non-malignant)	14/105 (13.3%)
Pneumonitis/pulmonary infiltrates	5/105 (4.8%)
Pneumothorax	1/105 (1%)
Voice changes/dysarthria	2/105 (1.9%)
Vascular disorders
Hypotension	1/105 (1%)
Hematoma	2/105 (1.9%)
Chyle or lymph leakage	1/105 (1%)
Thrombosis/thrombus/embolism	9/105 (8.6%)
Other (Not Including Serious) Adverse Events
	Minimally Invasive Esophagectomy (MIE)
	Affected / at Risk (%)	# Events
Total	74/105 (70.5%)
Blood and lymphatic system disorders
Anemia	11/105 (10.5%)
Cardiac disorders
Atrial fibrillation	14/105 (13.3%)
Gastrointestinal disorders
Dysphagia	11/105 (10.5%)
Metabolism and nutrition disorders
Hypoalbuminemia	7/105 (6.7%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	7/105 (6.7%)
Pleural effusion (non-malignant)	28/105 (26.7%)
Voice changes/dysarthria	12/105 (11.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.