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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: Minimally invasive esophagectomy (MIE)

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • Georgia
    • Savannah, Georgia, United States, 31403-3089
      • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
    • Chicago, Illinois, United States, 60611-3013
      • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Cancer Research Center
  • Minnesota
    • Hutchinson, Minnesota, United States, 55350
      • Hutchinson Area Health Care
    • Litchfield, Minnesota, United States, 55355
      • Meeker County Memorial Hospital
    • Maplewood, Minnesota, United States, 55109
      • HealthEast Cancer Care at St. John's Hospital
    • Minneapolis, Minnesota, United States, 55407
      • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center at University of Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center - Minneapolis
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital Cancer Care Center
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast Cancer Care at St. Joseph's Hospital
    • Shakopee, Minnesota, United States, 55379
      • St. Francis Cancer Center at St. Francis Medical Center
    • Woodbury, Minnesota, United States, 55125
      • HealthEast Cancer Care at Woodwinds Health Campus
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • CCOP - Missouri Valley Cancer Consortium
    • Omaha, Nebraska, United States, 68122
      • Immanuel Medical Center
    • Omaha, Nebraska, United States, 68124
      • Alegant Health Cancer Center at Bergan Mercy Medical Center
    • Omaha, Nebraska, United States, 68131-2197
      • Creighton University Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • Ohio
    • Bellefontaine, Ohio, United States, 43311
      • Mary Rutan Hospital
    • Chillicothe, Ohio, United States, 45601
      • Adena Regional Medical Center
    • Columbus, Ohio, United States, 43214-3998
      • Riverside Methodist Hospital Cancer Care
    • Columbus, Ohio, United States, 43222
      • Mount Carmel Health - West Hospital
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
    • Columbus, Ohio, United States, 43215
      • CCOP - Columbus
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center Cancer Care
    • Columbus, Ohio, United States, 43228
      • Doctors Hospital at Ohio Health
    • Delaware, Ohio, United States, 43015
      • Grady Memorial Hospital
    • Lancaster, Ohio, United States, 43130
      • Fairfield Medical Center
    • Marietta, Ohio, United States, 45750
      • Strecker Cancer Center at Marietta Memorial Hospital
    • Newark, Ohio, United States, 43055
      • Licking Memorial Cancer Care Program at Licking Memorial Hospital
    • Springfield, Ohio, United States, 45505
      • Community Hospital of Springfield and Clark County
    • Springfield, Ohio, United States, 45504
      • Mercy Medical Center
    • Westerville, Ohio, United States, 43081
      • Mount Carmel St. Ann's Cancer Center
    • Zanesville, Ohio, United States, 43701
      • Genesis - Good Samaritan Hospital
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-0001
      • Geisinger Cancer Institute at Geisinger Health
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Cancer Centers
    • State College, Pennsylvania, United States, 16801
      • Geisinger Medical Group - Scenery Park
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Conversion to Open Operation	Proportion of patients who required conversion to operation will be reported.	Assessed at surgery
Duration of Operating Time	The length of the operation (total of thoracic and abdominal components) is recorded.	Assessed at surgery
Duration of Intensive Care Stay	Number of post-operative days in intensive care is reported.	Assessed after surgery until patients are out of intensive care
Overall Length of Hospital Stay	The number of days patients stayed in the hospital after surgery is reported.	Assessed after surgery until patients are out of hospital
Total Number of Lymph Nodes Dissected	The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.	Assessed at surgery
3-year Survival Rate	Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.	Assessed at 3 years
30-day Peri-operative Mortality After Neoadjuvant Therapy	Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.	Assessed at 30 days after surgery
Rate of Conversion to Open Operation After Neoadjuvant Therapy	Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.	Assessed at surgery

Collaborators and Investigators

• Sponsor: Eastern Cooperative Oncology Group
• Collaborators: National Cancer Institute (NCI); Cancer and Leukemia Group B
• Investigators: Study Chair: James D. Luketich, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2004
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 8, 2003
• First Submitted That Met QC Criteria: July 8, 2003
• First Posted (Estimated): July 9, 2003

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: esophageal cancer; minimally invasive esophagectomy (MIE)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: CDR0000305866; U10CA021115 (U.S. NIH Grant/Contract); E2202 (Other Identifier: Eastern Cooperative Oncology Group (ECOG))