Impact of the Techniques for Intrathoracic Esophagogastric Anastomosis on Outcome in Ivor-Lewis Oesophagectomy
Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2010
CompletedFirst Posted
Study publicly available on registry
November 16, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 22, 2015
September 1, 2010
5.8 years
November 13, 2010
December 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Long and short outcome related with anastomoses
Include anastomotic leakage,anastomotic stricture,regurgitation,heartburn, dumping syndrome and anastomoses diameter.
3 year
Secondary Outcomes (1)
Quality of life and function outcomes
3 year
Study Arms (2)
side-to-side stapled esophagogastric anastomosis arm
EXPERIMENTALcircular-stapled esophagogastric anastomosis arm
ACTIVE COMPARATORInterventions
20 patients of distal esophageal cancer receive side-to-side stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy
20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Age \< 18 years
- History of significant heart disease
- Inoperable on the basis of co-existent medical problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YU zhen tao, M.D., Ph.D.
Tianjin Medical University Cancer Institute and Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2010
First Posted
November 16, 2010
Study Start
January 1, 2011
Primary Completion
November 1, 2016
Study Completion
December 1, 2016
Last Updated
December 22, 2015
Record last verified: 2010-09