Esophageal CancerNCT03646110
The Comparison of Single and Multi-incision MIE for Esophageal Cancer
A study testing Minimally invasive esophagectomy in people with Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Minimally invasive esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Aug 2018to 26 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of esophageal cancer
- Age between 35 to 75 years old
- Resectable tumor as evaluation by preoperative imaging studies.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Jang-Ming Lee
Taipei, Zhongzheng Dist., 100
Jang-Ming Lee, MD PhD, 886-972651439, jmlee@ntu.edu.tw
Pei-Wen Yang, PhD., 886-2-23123456 ext. 65123, pwy1210@gmail.com
About this study
Official title: The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- Minimally invasive esophagectomy
- Keywords
- esophageal cancer, Minimally invasive esophagectomy (MIE), single-incision Minimally invasive esophagectomy (SIMIE)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive esophagectomyProcedure or surgery
Minimally invasive esophagectomy is a surgical procedure for esophageal resection
| Study group | Role | What they receive |
|---|---|---|
| single-incision MIE | Experimental | Esophageal cancer patients received single-incision Minimally invasive esophagectomy Receives: Procedure: Minimally invasive esophagectomy |
| multi-incision MIE | Active comparator | Esophageal cancer patients received multi-incision Minimally invasive esophagectomy Receives: Procedure: Minimally invasive esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Overall survival rate of the participants after surgery
Measured: 60 months
Secondary outcomes (5)
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.
Measured: 1,7,14,28 days
Ratio of ambulation
30-minute walk test
Measured: post-operative day 2 (POD2)
Postoperative force vital capacity
Force vital capacity (FVC) is one of the most common parameters for pulmonary function measured in spirometry
Measured: 1 and 3 months
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
Measured: 1 and 3 months
Postoperative pulmonary complication
pulmonary complication after esophagectomy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start17 Aug 2018
- Primary completion26 Jul 2021 (estimated)
- Study completion26 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646110
- Sponsor's protocol ID
- 201804074RINA
- Status last verified
- Nov 2020
- First submitted
- 20 Aug 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03646110
- Acronym / sponsor ID
- 201804074RINA
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, Minimally invasive esophagectomy (MIE), single-incision Minimally invasive esophagectomy (SIMIE)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 26 Jul 2021 (estimated)
- Study completion
- 26 Jul 2021 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-incision MIE | Experimental | Procedure: Minimally invasive esophagectomyEsophageal cancer patients received single-incision Minimally invasive esophagectomy |
| multi-incision MIE | Active comparator | Procedure: Minimally invasive esophagectomyEsophageal cancer patients received multi-incision Minimally invasive esophagectomy |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of esophageal cancer
- Age between 35 to 75 years old
- Resectable tumor as evaluation by preoperative imaging studies.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive esophagectomyMinimally invasive esophagectomy is a surgical procedure for esophageal resection | Procedure or surgery | multi-incision MIE, single-incision MIE |
Primary outcome
Overall survival rate
Time frame: 60 months
Overall survival rate of the participants after surgery
5 secondary outcomes
Pain score as assessed by the face rating scale
Time frame: 1,7,14,28 days
Ratio of ambulation
Time frame: post-operative day 2 (POD2)
Postoperative force vital capacity
Time frame: 1 and 3 months
Post operative forced expiratory volume in one second
Time frame: 1 and 3 months
Postoperative pulmonary complication
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- previous SIMIE study 1Link provided by the sponsor.
- previous SIMIE study 2Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive esophagectomy in people with Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jang-Ming Lee, MD PhD (+886972651439, ntuhlee@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.