The Comparison of Single and Multi-incision MIE for Esophageal Cancer
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 17, 2018
CompletedFirst Submitted
Initial submission to the registry
August 20, 2018
CompletedFirst Posted
Study publicly available on registry
August 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2021
CompletedNovember 5, 2020
November 1, 2020
2.9 years
August 20, 2018
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival rate
Overall survival rate of the participants after surgery
60 months
Secondary Outcomes (5)
Pain score as assessed by the face rating scale
1,7,14,28 days
Ratio of ambulation
post-operative day 2 (POD2)
Postoperative force vital capacity
1 and 3 months
Post operative forced expiratory volume in one second
1 and 3 months
Postoperative pulmonary complication
1 month
Study Arms (2)
single-incision MIE
EXPERIMENTALEsophageal cancer patients received single-incision Minimally invasive esophagectomy
multi-incision MIE
ACTIVE COMPARATOREsophageal cancer patients received multi-incision Minimally invasive esophagectomy
Interventions
Minimally invasive esophagectomy is a surgical procedure for esophageal resection
Eligibility Criteria
You may qualify if:
- Patients with a diagnosis of esophageal cancer
- Age between 35 to 75 years old
- Resectable tumor as evaluation by preoperative imaging studies.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jang-Ming Lee
Taipei, Zhongzheng Dist., 100, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2018
First Posted
August 24, 2018
Study Start
August 17, 2018
Primary Completion
July 26, 2021
Study Completion
July 26, 2021
Last Updated
November 5, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share