The Comparison of Single and Multi-incision MIE for Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Minimally invasive esophagectomy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, Minimally invasive esophagectomy (MIE), single-incision Minimally invasive esophagectomy (SIMIE)
Eligibility Criteria
Inclusion Criteria:
- Patients with a diagnosis of esophageal cancer
- Age between 35 to 75 years old
- Resectable tumor as evaluation by preoperative imaging studies.
Exclusion Criteria:
- Previous surgery in the chest or abdomen.
- Receiving definitive chemoradiation (5500 cGy or more).
- Tumor invasion to the trachea, spine or aorta.
- Liver cirrhosis with esophageal varices or liver cirrhosis refractory to medical treatment, Child C classification.
- Previous history of cerebral vascular attack.
Sites / Locations
- Jang-Ming LeeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
single-incision MIE
multi-incision MIE
Arm Description
Esophageal cancer patients received single-incision Minimally invasive esophagectomy
Esophageal cancer patients received multi-incision Minimally invasive esophagectomy
Outcomes
Primary Outcome Measures
Overall survival rate
Overall survival rate of the participants after surgery
Secondary Outcome Measures
Pain score as assessed by the face rating scale
The scale range of face rating scale is ranging from 0 (happy face) to 10 (crying face). Higher values represent a worse outcome.
Ratio of ambulation
30-minute walk test
Postoperative force vital capacity
Force vital capacity (FVC) is one of the most common parameters for pulmonary function measured in spirometry
Post operative forced expiratory volume in one second
Forced expiratory volume in one second (FEV1) is one of the most common parameters for pulmonary function measured in spirometry
Postoperative pulmonary complication
pulmonary complication after esophagectomy
Full Information
NCT ID
NCT03646110
First Posted
August 20, 2018
Last Updated
November 3, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03646110
Brief Title
The Comparison of Single and Multi-incision MIE for Esophageal Cancer
Official Title
The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
July 26, 2021 (Anticipated)
Study Completion Date
July 26, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE).The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.
Detailed Description
Surgery remains the main stay of treating esophageal cancer. However, esophagectomy is a complex and technical demanding surgical procedure harboring substantial morbidity and mortality. Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. The standardized procedure including lymph node dissection, esophageal mobilization and reconstruction can be effectively performed under minimized wound incision whereas rendering the patients a possibility of faster postoperative recovery and reduced risk of perioperative postoperative pulmonary complication. The procedure of MIE including the thoracoscopic and laparoscopic phases which are usually performed multiple incisional wounds. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE). The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophageal cancer, Minimally invasive esophagectomy (MIE), single-incision Minimally invasive esophagectomy (SIMIE)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single-incision MIE
Arm Type
Experimental
Arm Description
Esophageal cancer patients received single-incision Minimally invasive esophagectomy
Arm Title
multi-incision MIE
Arm Type
Active Comparator
Arm Description
Esophageal cancer patients received multi-incision Minimally invasive esophagectomy
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive esophagectomy
Intervention Description
Minimally invasive esophagectomy is a surgical procedure for esophageal resection
Primary Outcome Measure Information:
Title
Overall survival rate
Description
Overall survival rate of the participants after surgery
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Pain score as assessed by the face rating scale
Description
The scale range of face rating scale is ranging from 0 (happy face) to 10 (crying face). Higher values represent a worse outcome.
Time Frame
1,7,14,28 days
Title
Ratio of ambulation
Description
30-minute walk test
Time Frame
post-operative day 2 (POD2)
Title
Postoperative force vital capacity
Description
Force vital capacity (FVC) is one of the most common parameters for pulmonary function measured in spirometry
Time Frame
1 and 3 months
Title
Post operative forced expiratory volume in one second
Description
Forced expiratory volume in one second (FEV1) is one of the most common parameters for pulmonary function measured in spirometry
Time Frame
1 and 3 months
Title
Postoperative pulmonary complication
Description
pulmonary complication after esophagectomy
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of esophageal cancer
Age between 35 to 75 years old
Resectable tumor as evaluation by preoperative imaging studies.
Exclusion Criteria:
Previous surgery in the chest or abdomen.
Receiving definitive chemoradiation (5500 cGy or more).
Tumor invasion to the trachea, spine or aorta.
Liver cirrhosis with esophageal varices or liver cirrhosis refractory to medical treatment, Child C classification.
Previous history of cerebral vascular attack.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jang-Ming Lee, MD PhD
Phone
+886972651439
Email
ntuhlee@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Wen Yang, PhD
Phone
+88623123456
Ext
65123
Email
pwy1210@gmail.com
Facility Information:
Facility Name
Jang-Ming Lee
City
Taipei City
State/Province
Zhongzheng Dist.
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang-Ming Lee, MD PhD
Phone
886-972651439
Email
jmlee@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Pei-Wen Yang, PhD.
Phone
886-2-23123456
Ext
65123
Email
pwy1210@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/26547093
Description
previous SIMIE study 1
URL
http://www.ncbi.nlm.nih.gov/pubmed/27826778
Description
previous SIMIE study 2
Learn more about this trial
The Comparison of Single and Multi-incision MIE for Esophageal Cancer
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