Know Cancer

or
forgot password

Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Peri-operative Mortality at 30 Days

Outcome Description:

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

Outcome Time Frame:

Assessed at 30 days from surgery

Safety Issue:

Yes

Principal Investigator

James D. Luketich, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

CDR0000305866

NCT ID:

NCT00063986

Start Date:

March 2004

Completion Date:

August 2012

Related Keywords:

  • Esophageal Cancer
  • esophageal cancer
  • minimally invasive esophagectomy (MIE)
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Medical City Dallas HospitalDallas, Texas  75230
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
CCOP - ColumbusColumbus, Ohio  43206
Mount Sinai Medical CenterNew York, New York  10029
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Mercy Medical CenterSpringfield, Ohio  45504
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Boston University Cancer Research CenterBoston, Massachusetts  02118