Back to resultsThe Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?
Primary Purpose
Anastomotic Leakage
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Narrowed Gastric Conduit
Widened Gastric Conduit
Sponsored by
About this trial
This is an interventional treatment trial for Anastomotic Leakage focused on measuring minimally invasive esophagectomy, anastomotic leakage, gastric conduit
Eligibility Criteria
Inclusion Criteria:
- Patients underwent minimally invasive esophagectomy(three-hole procedure)
- Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy
Exclusion Criteria:
- With previous cancer history
- Severe Co-morbidity
Sites / Locations
- Division of Thoracic Surgery, Zhongshan Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Narrow Gastric Conduit
Wide Gastric Conduit
Arm Description
The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy
The group in which widened gastric conduit will be performed during minimally invasive esophagectomy
Outcomes
Primary Outcome Measures
The anastomotic leakage rate
The anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01696682
Brief Title
The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?
Official Title
Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation.
Detailed Description
Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be assigned to wide or narrow gastric conduit group randomly. Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the rate of anastomotic leakage, together with its clinical details will be recorded in the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leakage
Keywords
minimally invasive esophagectomy, anastomotic leakage, gastric conduit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Narrow Gastric Conduit
Arm Type
Experimental
Arm Description
The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy
Arm Title
Wide Gastric Conduit
Arm Type
Experimental
Arm Description
The group in which widened gastric conduit will be performed during minimally invasive esophagectomy
Intervention Type
Procedure
Intervention Name(s)
Narrowed Gastric Conduit
Other Intervention Name(s)
Narrowed Gastric Tube
Intervention Description
The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy
Intervention Type
Procedure
Intervention Name(s)
Widened Gastric Conduit
Other Intervention Name(s)
Wide Gastric Tube
Intervention Description
A widened gastric tube will be formed during the surgery
Primary Outcome Measure Information:
Title
The anastomotic leakage rate
Description
The anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database.
Time Frame
the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients underwent minimally invasive esophagectomy(three-hole procedure)
Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy
Exclusion Criteria:
With previous cancer history
Severe Co-morbidity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaxing Shen, MD
Phone
86-13661983366
Email
SHEN.YAXING@ZS-HOSPITAL.SH.CN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijie Tan, MD
Organizational Affiliation
Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Division of Thoracic Surgery, Zhongshan Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaxing Shen, MD
Phone
86-13661983366
Email
shen.yaxing@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Hao Wang, MD
12. IPD Sharing Statement
Learn more about this trial
The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?
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