Minimally Invasive SurgeryNCT04206696
Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure
An observational study of Minimally Invasive Surgery, run by The Second Hospital of Shandong University.
Trial summary
Minimally invasive oesophagectomy is a technically demanding procedure; thus, the learning curve of this procedure should be explored. Then the mature minimally invasive oesophagectomy procedure should be contrasted with the open procedure. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Minimally Invasive Surgery
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2010to 1 Jan 2019
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy.
Who may be able to join
- oesophageal cancer diagnosed by endoscopy and biopsy good cardiopulmonary function to tolerate surgery
Who cannot join
- poor cardiopulmonary function distant metastasis T4 with little possibility of radical resection
About this study
Minimally invasive oesophagectomy is a technically demanding procedure; thus, the learning curve of this procedure should be explored. Then the mature minimally invasive oesophagectomy procedure should be contrasted with the open procedure.
Read the detailed description
Between July 2010 and August 2016, 214 patients underwent MIE (thoracoscopic-laparoscopic oesophagectomy) for oesophageal squamous cell carcinoma in the Thoracic Department, The Second Hospital of Shandong University. Eight of these 214 patients were converted to thoracotomy or laparotomy, one patient was unable to tolerate single-lung ventilation due to a history of left upper lobectomy, and the other seven patients were due to bleeding controlling. Among the 214 patients enrolled, there were 182 males and 32 females in the MIE group. A total of 170 patients underwent oesophagectomy by open thoracotomy from August 2014 to August 2016, and these patients were defined as the open group. The data from the patients in the open group were compared with those of the patients who underwent thoracoscopic-laparoscopic oesophagectomy during the same clinical period. All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy, with routine thoracic and abdominal enhanced computed tomography (CT) scans and endoscopic ultrasonography to evaluate the clinical TNM stage. The operations were performed by a single surgical team. This study was approved by the ethics committee and Medical Administration Division of the Second Hospital of Shandong University. Written informed consent was obtained from each of the enrolled patients. All methods performed in the investigator's study were conducted in accordance with the relevant guidelines and regulations.
- Conditions
- Minimally Invasive Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding volume
bleeding volume in milliliter
Measured: Between July 2010 and August 2016
operation time
operation time in minutes
Measured: Between July 2010 and August 2016
complications
complications in percentage
Measured: Between July 2010 and August 2016
mortality
mortality in percentage
Measured: Between July 2010 and August 2016
lymphadenectomy
lymphadenectomy in number
Measured: Between July 2010 and August 2016
Secondary outcomes (2)
2-year overall survival rate
2-year overall survival in percentage
Measured: Between August 2016 and August 2018
2-year disease-free survival
2-year disease-free survival in percentage
Measured: Between August 2016 and August 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jul 2010
- Primary completion1 Aug 2016
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaogang Zhao, Doctor, Study director, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206696
- Sponsor's protocol ID
- MIE ZYP1
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure
- ClinicalTrials.gov ID
- NCT04206696
- Acronym / sponsor ID
- MIE ZYP1
- Conditions
- Minimally Invasive Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 20 Dec 2019 (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 oesophagectomy is a technically demanding procedure; thus, the learning curve of this procedure should be explored. Then the mature minimally invasive oesophagectomy procedure should be contrasted with the open procedure.
Detailed description
Between July 2010 and August 2016, 214 patients underwent MIE (thoracoscopic-laparoscopic oesophagectomy) for oesophageal squamous cell carcinoma in the Thoracic Department, The Second Hospital of Shandong University. Eight of these 214 patients were converted to thoracotomy or laparotomy, one patient was unable to tolerate single-lung ventilation due to a history of left upper lobectomy, and the other seven patients were due to bleeding controlling. Among the 214 patients enrolled, there were 182 males and 32 females in the MIE group. A total of 170 patients underwent oesophagectomy by open thoracotomy from August 2014 to August 2016, and these patients were defined as the open group. The data from the patients in the open group were compared with those of the patients who underwent thoracoscopic-laparoscopic oesophagectomy during the same clinical period. All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy, with routine thoracic and abdominal enhanced computed tomography (CT) scans and endoscopic ultrasonography to evaluate the clinical TNM stage. The operations were performed by a single surgical team. This study was approved by the ethics committee and Medical Administration Division of the Second Hospital of Shandong University. Written informed consent was obtained from each of the enrolled patients. All methods performed in the investigator's study were conducted in accordance with the relevant guidelines and regulations.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy.
Key inclusion criteria (1 listed)
- oesophageal cancer diagnosed by endoscopy and biopsy good cardiopulmonary function to tolerate surgery
Key exclusion criteria (1 listed)
- poor cardiopulmonary function distant metastasis T4 with little possibility of radical resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
bleeding volume
Time frame: Between July 2010 and August 2016
bleeding volume in milliliter
operation time
Time frame: Between July 2010 and August 2016
operation time in minutes
complications
Time frame: Between July 2010 and August 2016
complications in percentage
mortality
Time frame: Between July 2010 and August 2016
mortality in percentage
lymphadenectomy
Time frame: Between July 2010 and August 2016
lymphadenectomy in number
2 secondary outcomes
2-year overall survival rate
Time frame: Between August 2016 and August 2018
2-year disease-free survival
Time frame: Between August 2016 and August 2018
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 20 Dec 2019.
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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.
Xiaogang Zhao, Doctor study director
The Second Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Invasive Surgery, run by The Second Hospital of Shandong University.
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 1 inclusion and 1 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
bleeding volume (time frame: Between July 2010 and August 2016). The study lists 5 primary outcomes in all. 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 20 Dec 2019.