Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparison of Ivor Lewis and Tri-incision Approaches for Patients With Esophageal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02017002
First received: December 16, 2013
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

Esophagectomy for esophageal cancer is a technically complex procedure which is associated with high perioperative mortality, even in high volume centers[1]. To facilitate the postoperative recovery of esophagectomies patients by reducing surgical trauma, an increasing number of surgeons have attempted minimally invasive esophagectomy (MIE) to treat patients with esophageal cancer.[2-10] However, there is no consensus regarding the optimal method for performing an esophagectomy with the minimally invasive surgical technique. In addition, the benefit of this approach has not been well confirmed based on the limited retrospective comparative studies at the present time [3, 11-12], although its potential benefit improving the immediate postoperative including the total morbidity and pulmonary complication has been demonstrated by meta-analyses[13]. Especially it is unclear whether adding laparoscopic procedures in MIE can contribute to further improvement of the perioperative outcome of the patients.[3] Previously, the investigators have found that adding of laparoscopic procedure in performing the esophageal reconstruction procedure after VATS esophagectomy can provide further benefit in reducing the postoperative major complications and fasten the postoperative recovery16. For the most cases, the patients was receiving tri-incision esophagectomy, i.e. VATS esophagectomy in the chest, laparoscopic gastric mobilization in the abdomen and left cervical esophagogastrostomy. In such circumstances, a cervical incision was required for esophagogastrostomy after esophagectomy and gastric mobilization. However, for the patients with lower-to mid third esophageal cancer, some surgeon performed Ivor Lewis esophagectomy, which performing the esophagogastrostomy in the chest after gastric mobilization without cervical incision wound. Although both of these procedures have been demonstrated to be feasible and safe, there is much debate about the advantage and disadvantage of these two approaches. For tri-incision esophagectomy, patients have the chance to have cervical lymph node dissection and the esophagus can be resected up to the neck. However, it is more time-consuming and associated with more surgical trauma by adding a cervical incisional wound and more tissue dissection around the cervical trachea as compared to that done by Ivor Lewis esophagectomy. In contrast, for the Ivor Lewis esophagectomy, the resection of esophagus was limited to the level of thoracic inlet and cervical lymph node dissection was impossible unless a neck incision was further created. However, it takes less time in performing the whole procedure by saving a neck incision.


Condition Intervention
Surgical Procedures
Minimally Invasive
Operative
Esophageal Neoplasms
Cancer of Esophagus
Esophagectomy
Procedure: Ivor Lewis
Procedure: Tri-incision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Ivor Lewis and Tri-incision Approaches in Performing Minimally

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Overall survival duration [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Surgical complication [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Postoperative ICU stay and hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Change of lung function after surgery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tri-incision
a cervical incision was required for esophagogastrostomy after esophagectomy and gastric mobilization
Procedure: Tri-incision
a cervical incision was required for esophagogastrostomy after esophagectomy and gastric mobilization
Other Name: Tri-incision
Placebo Comparator: Ivor Lewis
for the patients with lower-to mid third esophageal cancer, some surgeon performed Ivor lewis esophagectomy, which performing the esophago-gastrostomy in the chest after gastric mobilization without cervical incision wound
Procedure: Ivor Lewis
for the patients with lower-to mid third esophageal cancer, some surgeon performed Ivor lewis esophagectomy, which performing the esophago-gastrostomy in the chest after gastric mobilization without cervical incision wound
Other Name: Ivor-Lewis

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of esophageal cancer
  • Age: below 75 years old.
  • Tumor location: 2 cm above GEJ and 5 cm below thoracic inlet.
  • Tumor stage: less than TNM stage III

Exclusion Criteria:

  • Poor lung function with FEV1 less than 70% of prediction.
  • Major systemic co-morbidity : e.g. CVA, end-stage renal disease, coronary artery disease, congestive heart failure.
  • Presence of tracheal invasion or distant metastasis of the tumor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017002

Contacts
Contact: Jang-Ming Lee, doctor +886-2-23123456 ext 65123 jangming@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jang-Ming Lee, doctor    +886-2-23123456 ext 65123    jangming@ntuh.gov.tw   
Principal Investigator: Jang-Ming Lee, doctor         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jang-MIng Lee, doctor National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02017002     History of Changes
Other Study ID Numbers: 201308069DIND
Study First Received: December 16, 2013
Last Updated: June 27, 2014
Health Authority: Taiwan: Ministry of Health and Welfare

Keywords provided by National Taiwan University Hospital:
Esophageal cancer
minimally invasive
Surgical Procedures
Esophagectomy

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 25, 2014