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

NCT02017002 | Unknown

• 1 other identifier: 201308069DIND
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Procedures; Minimally Invasive; Operative; Esophageal Neoplasms; Cancer of Esophagus; Esophagectomy

Keywords

Esophageal cancer; minimally invasive; Surgical Procedures; Esophagectomy

Outcome Measures

Primary Outcomes (1)

• Overall survival duration

  2 years

Secondary Outcomes (4)

• Surgical complication

  2 years

• Postoperative ICU stay and hospital stay

  1 month

• Quality of Life

  2 years

• Change of lung function after surgery

  2 years

Study Arms (2)

Tri-incision

ACTIVE COMPARATOR

a cervical incision was required for esophagogastrostomy after esophagectomy and gastric mobilization

Procedure: Tri-incision

Ivor Lewis

PLACEBO COMPARATOR

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

Interventions

Ivor Lewis PROCEDURE

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

Also known as: Ivor-Lewis

Ivor Lewis

Tri-incision PROCEDURE

a cervical incision was required for esophagogastrostomy after esophagectomy and gastric mobilization

Tri-incision

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Jang-MIng Lee, doctor

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jang-Ming Lee, doctor

CONTACT

+886-2-23123456; jangming@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: June 30, 2014

Record last verified: 2014-06

Locations

TW (1)