Esophageal CancerNCT03428074
A Observational Study to Compare Effectiveness and Safety of the Surgeries in Patients With Esophageal Cancer
An observational study of Esophageal Cancer, run by Chinese PLA General Hospital at 9 sites in China.
Trial summary
The study was designed to compare effectiveness and safety of the surgeries of Ivor-Lewis and Mckeown in patients with esophageal cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 1,862 participants
- Where
- 9 sitesChina
- Study dates
- 1 Dec 2017to 30 Mar 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pathogically diagnosed IA-IIIB patients with esophageal cancer who received the surgeries of Ivor-Lewis and Mckeown
Who may be able to join
- Pathologically diagnosed middle and lower thoracic IA-IIIB esophageal cancer after surgeries;
- Patients who received minimally invasive radical dissections of Ivor-Lewis and Mckeown;
- Patients who received tubular gastroesophageal reconstruction;
Who cannot join
- Patients complicated with arrhythmia, or serious disfunctions of heart, lung, liver, and kidney before surgeries;
- Patients with second primary tumors;
- Patients who received abdominal or thoracic surgeries;
- Patients who received gastrostomy or nesteostomy before surgeries;
- Patients with suspected cervical lymph metastases (in the subgroup of the patients who received the surgery of Mckeown)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, 610041
First Hospital Affiliated to Medical College, Zhejiang University
Hangzhou, Zhejiang, 310003
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, 430030
Xi'an Tangdu Hospital
Xi'an, Shaanxi, 710000
Henan cancer hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Multi-centre Real-world Non-interventional Observational Study to Compare Effectiveness and Safety of the Minimally Invasive Surgeries of Ivor-Lewis and Mckeown in Chinese Patients With IA-IIIB Esophageal Cancer
The study was designed to compare effectiveness and safety of the surgeries of Ivor-Lewis and Mckeown in patients with esophageal cancer
Read the detailed description
The trial is a multi-centre real-world non-interventional observational study. The study was designed to compare effectiveness and safety of the minimally invasive surgeries of Ivor-Lewis and Mckeown in the Chinese patients with IA-IIIB esophageal cancer via a retrospectively review method based on the study data on patient demographic/tumor biological characteristics and clinical treatments.
- Conditions
- Esophageal Cancer
- Being tested
- Surgeries
- Keywords
- Chinese, esophageal cancer, surgeries of Ivor-Lewis/Mckeown
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeriesProcedure or surgery
Minimally invasive surgeries of Ivor-Lewis and Mckeown
| Study group | Role | What they receive |
|---|---|---|
| Patients with the surgery of Ivor-Lewis | Pathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Ivor-Lewis Receives: Procedure: Surgeries | |
| Patients with the surgery of Mckeown | Pathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Mckeown Receives: Procedure: Surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survivals in patients with esophageal cancer who received surgeries
Overall survivals in patients with esophageal cancer who received surgeries categorised by tumor biological characteristics
Measured: 2010 - 2017
Secondary outcomes (1)
Death rates within 30 days after surgeries
Death rates within 30 days after surgeries categorised by tumor biological characteristics
Measured: 2010 - 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Dec 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, Yang Liu, Chinese PLA General Hospital
- Investigators
- Yang Liu, PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428074
- Sponsor's protocol ID
- 301-EC-01
- Status last verified
- May 2018
- First submitted
- 5 Feb 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang T, Hou X, Li Y, Fu X, Liu L, Xu L, Liu Y. Effectiveness and safety of minimally invasive Ivor Lewis and McKeown oesophagectomy in Chinese patients with stage IA-IIIB oesophageal squamous cell cancer: a multicentre, non-interventional and observational study. Interact Cardiovasc Thorac Surg. 2020 Jun 1;30(6):812-819. doi: 10.1093/icvts/ivaa038.
PubMed 32285107
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Real-world Non-interventional Observational Study to Compare Effectiveness and Safety of the Minimally Invasive Surgeries of Ivor-Lewis and Mckeown in Chinese Patients With IA-IIIB Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03428074
- Acronym / sponsor ID
- 301-EC-01
- Conditions
- Esophageal Cancer
- Keywords
- Chinese, esophageal cancer, surgeries of Ivor-Lewis/Mckeown
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,862 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 9 Feb 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.
The study was designed to compare effectiveness and safety of the surgeries of Ivor-Lewis and Mckeown in patients with esophageal cancer
Detailed description
The trial is a multi-centre real-world non-interventional observational study. The study was designed to compare effectiveness and safety of the minimally invasive surgeries of Ivor-Lewis and Mckeown in the Chinese patients with IA-IIIB esophageal cancer via a retrospectively review method based on the study data on patient demographic/tumor biological characteristics and clinical treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with the surgery of Ivor-Lewis | – | Procedure: SurgeriesPathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Ivor-Lewis |
| Patients with the surgery of Mckeown | – | Procedure: SurgeriesPathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Mckeown |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pathogically diagnosed IA-IIIB patients with esophageal cancer who received the surgeries of Ivor-Lewis and Mckeown
Key inclusion criteria (3 listed)
- Pathologically diagnosed middle and lower thoracic IA-IIIB esophageal cancer after surgeries;
- Patients who received minimally invasive radical dissections of Ivor-Lewis and Mckeown;
- Patients who received tubular gastroesophageal reconstruction;
Key exclusion criteria (5 listed)
- Patients complicated with arrhythmia, or serious disfunctions of heart, lung, liver, and kidney before surgeries;
- Patients with second primary tumors;
- Patients who received abdominal or thoracic surgeries;
- Patients who received gastrostomy or nesteostomy before surgeries;
- Patients with suspected cervical lymph metastases (in the subgroup of the patients who received the surgery of Mckeown)
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 |
|---|---|---|
| SurgeriesMinimally invasive surgeries of Ivor-Lewis and Mckeown | Procedure or surgery | Patients with the surgery of Ivor-Lewis, Patients with the surgery of Mckeown |
Primary outcome
Overall survivals in patients with esophageal cancer who received surgeries
Time frame: 2010 - 2017
Overall survivals in patients with esophageal cancer who received surgeries categorised by tumor biological characteristics
1 secondary outcome
Death rates within 30 days after surgeries
Time frame: 2010 - 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Derived from this study: PubMed 32285107Zhang T, Hou X, Li Y, Fu X, Liu L, Xu L, Liu Y. Effectiveness and safety of minimally invasive Ivor Lewis and McKeown oesophagectomy in Chinese patients with stage IA-IIIB oesophageal squamous cell cancer: a multicentre, non-interventional and observational study. Interact Cardiovasc Thorac Surg. 2020 Jun 1;30(6):812-819. doi: 10.1093/icvts/ivaa038.
- 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.
Yang Liu, PhD principal investigator
Chinese PLA General Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Chinese PLA General Hospital at 9 sites in China.
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: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survivals in patients with esophageal cancer who received surgeries (time frame: 2010 - 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03428074, which also lists 1 linked publication.
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 21 May 2018.