Impact of the Techniques for Intrathoracic Esophagogastric Anastomosis on Outcome in Ivor-Lewis Oesophagectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01242124
First received: November 13, 2010
Last updated: March 24, 2014
Last verified: September 2010
  Purpose

The purpose of this study is to determine the safety and efficacy of the side-to-side stapled intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.


Condition Intervention Phase
Esophageal Cancer
Procedure: side-to-side stapled esophagogastric anastomosis
Procedure: circular-stapled esophagogastric anastomosis
Phase 2
Phase 3

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: Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Long and short outcome related with anastomoses [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    Include anastomotic leakage,anastomotic stricture,regurgitation,heartburn, dumping syndrome and anastomoses diameter.


Secondary Outcome Measures:
  • Quality of life and function outcomes [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: side-to-side stapled esophagogastric anastomosis arm Procedure: side-to-side stapled esophagogastric anastomosis
20 patients of distal esophageal cancer receive side-to-side stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy
Active Comparator: circular-stapled esophagogastric anastomosis arm Procedure: circular-stapled esophagogastric anastomosis
20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer of the distal esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
  • Received no previous treatment for esophageal cancer
  • Adequate bone marrow, liver and kidney function
  • Patients must be able to understand the nature consent of the study and give written informed consent.

Exclusion Criteria:

  • Age < 18 years
  • History of significant heart disease
  • Inoperable on the basis of co-existent medical problems
  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: NCT01242124

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
Tianjin, Tianjin, China
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Principal Investigator: YU zhen tao, M.D., Ph.D. Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01242124     History of Changes
Other Study ID Numbers: TMU-CIH-ECC-001
Study First Received: November 13, 2010
Last Updated: March 24, 2014
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on July 23, 2014