The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?
Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 11, 2013
February 1, 2013
1.2 years
September 22, 2012
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Study Arms (2)
Narrow Gastric Conduit
EXPERIMENTALThe group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy
Wide Gastric Conduit
EXPERIMENTALThe group in which widened gastric conduit will be performed during minimally invasive esophagectomy
Interventions
The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy
A widened gastric tube will be formed during the surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- With previous cancer history
- Severe Co-morbidity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Division of Thoracic Surgery, Zhongshan Hospital of Fudan University
Shanghai, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lijie Tan, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery; Vice Chief, Division of Thoracic Surgery
Study Record Dates
First Submitted
September 22, 2012
First Posted
October 1, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
February 11, 2013
Record last verified: 2013-02