Esophagus CancerNCT06147180
Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy
An observational study of Esophagus Cancer and Esophagectomy, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
To analyze and compare the long-term recurrence-free survival rate, overall survival rate and quality of survival after minimally invasive esophagectomy and open esophagectomy, and to conduct subgroup analysis according to the type of esophageal cancer and pathological stage, etc., and to explore more deeply the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophagus Cancer, Esophagectomy, Quality of Life
- How many people
- 1,474 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2023to 31 Aug 2026
- 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: Patients who had undergone esophageal cancer resection at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, between 2013 and 2021.
Who may be able to join
- Patients who had undergone esophageal cancer resection at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, between 2013 and 2021, with pathology results confirming esophageal squamous carcinoma, adenocarcinoma, or other malignant tumors.
- The surgery was successfully completed, the patient was safely discharged from the hospital, the postoperative follow-up was successful, and if the follow-up patient died, his or her death was due to natural causes.
Who cannot join
- Perioperative patient deaths, pathologic findings other than those listed above, loss of visits, and postoperative unnatural deaths.
Trial locations and contacts
1 site in 1 country.
China1 site
Qilu Hospital of Shandong University
Ji'nan, Shandong, 250012
Tui Tian
Zhanpeng Tang
About this study
Official title: Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy for Esophageal Cancer: a Retrospective Cohort Study
To analyze and compare the long-term recurrence-free survival rate, overall survival rate and quality of survival after minimally invasive esophagectomy and open esophagectomy, and to conduct subgroup analysis according to the type of esophageal cancer and pathological stage, etc., and to explore more deeply the differences between minimally invasive esophagectomy and open esophagectomy in terms of the benefits for different types of patients, so as to provide reference for the selection of the clinical surgical methods. We will also use the available data to analyze the influence of other factors on patients\' long-term survival after surgery.
Read the detailed description
- Purpose of the study To study the differences in long-term disease-free survival rate and overall survival rate after minimally invasive esophagectomy and open esophagectomy, as well as postoperative quality of life, and to prove whether the choice of surgical modality has an impact on the postoperative long-term survival of esophageal cancer patients, and to explore the target population that can benefit more from minimally invasive esophagectomy compared with open esophagectomy, so as to provide a The study will also explore the target population that can benefit more from minimally invasive esophagectomy than open esophagectomy, so as to provide a certain reference value for the selection of surgical methods in clinics. To analyze the impact of other baseline data on patients\' long-term survival and quality of life after surgery using the available data.
- Content of the study To retrieve the electronic medical records of patients who had undergone esophageal cancer resection at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, between 2013 and 2021, to collect their baseline data, and to classify patients into minimally invasive surgery and open surgery groups according to surgical modalities, and to match the propensity scores of patients in the two groups on the important baseline data, and to collect the postoperative recurrence of metastasis, survival, and the quality of life of the patients through the follow up visits To compare the long-term recurrence-free survival rate, overall survival rate and quality of life between the two groups, and to analyze the subgroups according to the type of esophageal cancer, pathological stage, and whether neoadjuvant therapy was performed, so as to explore more deeply the differences between minimally invasive esophagectomy and open esophagectomy in terms of postoperative long-term survival for patients with different types of esophageal cancers. And to analyze the influence of other baseline information on patients\' postoperative long-term survival and quality of life.
- Observed Indicators The main outcomes observed in this study were disease-free survival and overall survival after surgery.Survival was calculated: if the patient survived from the date of surgery to the date of follow-up, the survival period was from the date of surgery to the date of follow-up, and if the patient died between the date of surgery and the date of follow-up, the survival period was from the date of surgery to the date of death. Calculation of disease-free survival: from the date of surgery to the date of the first detection of recurrent metastatic disease between the date of surgery and the date of follow-up; the criterion for recurrence is the presence of metastases to other organs or lymph nodes after surgery confirmed by histology or imaging. Observation time: the patient\'s time from the first postoperative date to 5 full years postoperatively was taken as the observation time. Follow-up outcome: patient\'s death, loss to follow-up, or patient\'s survival at 5 full years postoperatively from the first postoperative date to 5 full years postoperatively were considered as the primary observation outcomes. Since the patients in this study were from patients who had undergone esophagectomy for esophageal cancer at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, during the period 2013-2021, the follow-up period was set at 3 years from the date of ethical approval - 3 years after the ethical approval was granted, which would allow all patients to reach the observation period of 5 years, and for cancer patients, the 3 and 5 year survival rates are very important prognostic data.
- Data collection Collection of patients\' baseline data: baseline data of patients who had undergone esophagectomy for esophageal cancer at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, and were successfully discharged from the hospital during the period from 2013 to 2021 were collected through the electronic medical record system, including, but not limited to, hospitalization number, name, gender, age, occupation, marital status, contact phone number, underlying disease, history of smoking and alcohol consumption, family history, PS score, body weight (kg), height (m ), ASA score, tumor site, date of surgery, duration of surgery (min), mode of surgery, intraoperative bleeding (ml), duration of surgery (min), blood routine, blood biochemistry, blood type, pathological results, lung function, postoperative course, and surgical complications. Collection of patients\' postoperative survival data: follow-up to collect patients\' postoperative survival data information, including, whether they were alive at the time of the follow-up date, the specific date of death, whether they died due to this disease, whether they had recurrent metastasis, the time of the first recurrent metastasis, and the information on the quality of postoperative survival, which was obtained according to the EORTC QLQ-OES18 quality of life questionnaire.
- Statistical analysis For the baseline data collected from patients, it was initially planned to use propensity score matching, with the minimally invasive surgery group and the open surgery group in a 1:1 ratio, so that the data of the two groups would be consistent in terms of baseline data; after obtaining the survival data of the patients in the postoperative period, the comparison of the continuous variables was performed using the Wilcoxon test/Mann Whitney U test or Student t-test, and the categorical variables were analyzed using the Pearson chi-square test or Fisher exact test. Categorical variables were reported as frequencies, percentages, and P values, and continuous variables were reported as means, ranges, and P values. The long-term recurrence-free survival and overall survival rates of the two groups and their 95% CIs were analyzed, and the hazard ratios of recurrence-free survival and overall survival and the differences between recurrence-free survival and overall survival were compared to see whether the differences were statistically significant; if the differences in the survival rates were statistically significant, there was a certain relationship between the long-term survival of esophageal cancer and the surgical modality, and if the differences were not statistically significant, it indicated that the two surgical In subgroup analysis, the long-term recurrence-free survival rate and overall survival rate and their 95% CIs were calculated for squamous carcinoma, adenocarcinoma, other malignant tumors, and different pathological stage subgroups, and the hazard ratios of the recurrence-free survival rate and overall survival rate and the differences between the recurrence-free survival rate and overall survival rate of the two groups were compared between the subgroups to see whether the differences were statistically significant or not, the difference was statistically significant for subgroups with statistically significant differences, indicating that there was a certain relationship between postoperative survival and surgery. statistically significant subgroups suggests that the choice of surgical modality can benefit patients with that characteristic, and thus there is a tendency to choose a more beneficial surgical modality for patients in clinical work. On the other hand, the EORTC QLQ-OES18 quality of life questionnaire classified the outcomes into 10 domains such as dysphagia, and by collecting information on the quality of life of surviving patients, we analyzed and compared whether there were differences in the quality of life of the two groups of patients in the different functional domains, so as to compare whether there was any effect of surgical modality on the quality of life of the patients in the postoperative period. Utilizing the available information, other factors were explored to find out whether there was any influence of other factors on postoperative survival and quality of life.
- Conditions
- Esophagus Cancer, Esophagectomy, Quality of Life, Survival
- Keywords
- esophagus Cancer, invasive esophagectomy, open esophagectomy, long-term survival, quality of life
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive esophageal cancer resection group | Surgical Procedures: minimally invasive esophagectomy | |
| Open esophageal cancer resection group | Surgical Procedures: open esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Information
Dead or alive 5 years after surgery
Measured: From enrollment to 5 years after surgery
score of Quality of life
Measured with EORTC QLQ-OES18 Quality of Life Questionnaire
Measured: From enrollment to 5 years after surgery
Secondary outcomes (1)
Recurrence or metastasis
Imaging, lab results
Measured: From enrollment to 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start27 Nov 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Tian, Doctor, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147180
- Sponsor's protocol ID
- MR-37-23-034233
- Status last verified
- Oct 2023
- First submitted
- 19 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Liu C, Liu Y, Yao S, Xu B, Dong G. Comparisons between minimally invasive and open esophagectomy for esophageal cancer with cervical anastomosis: a retrospective study. J Cardiothorac Surg. 2020 Jun 8;15(1):128. doi: 10.1186/s13019-020-01182-3.
PubMed 32513211Zheng Y, Li Y, Liu X, Sun H, Shen S, Ba Y, Wang Z, Liu S, Xing W. Minimally Invasive Versus Open McKeown for Patients with Esophageal Cancer: A Retrospective Study. Ann Surg Oncol. 2021 Oct;28(11):6329-6336. doi: 10.1245/s10434-021-10105-y. Epub 2021 May 13.
PubMed 33987755Ising MS, Smith SA, Trivedi JR, Martin RCG, Phillips P, Van Berkel V, Fox MP. Minimally Invasive Esophagectomy Is Associated with Superior Survival Compared to Open Surgery. Am Surg. 2023 May;89(5):1833-1843. doi: 10.1177/00031348221078962. Epub 2022 Mar 23.
PubMed 35317621Chen HS, Lin CH, Wu SC, Wang BY. Comparing survival between neoadjuvant chemoradiotherapy followed by open or thoracoscopic oesophagectomy in patients with oesophageal squamous cell carcinoma. Eur J Cardiothorac Surg. 2022 Jul 11;62(2):ezac114. doi: 10.1093/ejcts/ezac114.
PubMed 35303068van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LAA, Joore HCA, Kroese CC, Haj Mohammad N, Mook S, Vleggaar FP, Borel Rinkes IHM, Ruurda JP, van Hillegersberg R. Robot-assisted Minimally Invasive Thoracolaparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer: A Randomized Controlled Trial. Ann Surg. 2019 Apr;269(4):621-630. doi: 10.1097/SLA.0000000000003031.
PubMed 30308612Knitter S, Andreou A, Hofmann T, Chopra S, Denecke C, Thuss-Patience PC, Kroll D, Bahra M, Schmelzle M, Pratschke J, Biebl M. Minimally Invasive Versus Open Ivor-Lewis Esophagectomy for Esophageal Cancer or Cancer of the Gastroesophageal Junction: Comparison of Postoperative Outcomes and Long-term Survival Using Propensity Score Matching Analysis. Anticancer Res. 2021 Jul;41(7):3499-3510. doi: 10.21873/anticanres.15137.
PubMed 34230145Gottlieb-Vedi E, Kauppila JH, Mattsson F, Lindblad M, Nilsson M, Lagergren P, Rouvelas I, Lagergren J; FINEGO group. Long-term Survival in Esophageal Cancer After Minimally Invasive Esophagectomy Compared to Open Esophagectomy. Ann Surg. 2022 Dec 1;276(6):e744-e748. doi: 10.1097/SLA.0000000000004645. Epub 2021 Jan 20.
PubMed 33480612Giulini L, Dubecz A. Minimally invasive versus open oesophagectomy for cancer: propensity score analysis improves results' reliability but matching criteria need to be selected accurately. Eur J Cardiothorac Surg. 2022 Jul 11;62(2):ezac192. doi: 10.1093/ejcts/ezac192. No abstract available.
PubMed 35349668
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy for Esophageal Cancer: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06147180
- Acronym / sponsor ID
- MR-37-23-034233
- Conditions
- Esophagus Cancer, Esophagectomy, Quality of Life, Survival
- Keywords
- esophagus Cancer, invasive esophagectomy, open esophagectomy, long-term survival, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,474 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 27 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 27 Nov 2023 (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.
To analyze and compare the long-term recurrence-free survival rate, overall survival rate and quality of survival after minimally invasive esophagectomy and open esophagectomy, and to conduct subgroup analysis according to the type of esophageal cancer and pathological stage, etc., and to explore more deeply the differences between minimally invasive esophagectomy and open esophagectomy in terms of the benefits for different types of patients, so as to provide reference for the selection of the clinical surgical methods. We will also use the available data to analyze the influence of other factors on patients\' long-term survival after surgery.
Detailed description
- Purpose of the study To study the differences in long-term disease-free survival rate and overall survival rate after minimally invasive esophagectomy and open esophagectomy, as well as postoperative quality of life, and to prove whether the choice of surgical modality has an impact on the postoperative long-term survival of esophageal cancer patients, and to explore the target population that can benefit more from minimally invasive esophagectomy compared with open esophagectomy, so as to provide a The study will also explore the target population that can benefit more from minimally invasive esophagectomy than open esophagectomy, so as to provide a certain reference value for the selection of surgical methods in clinics. To analyze the impact of other baseline data on patients\' long-term survival and quality of life after surgery using the available data.
- Content of the study To retrieve the electronic medical records of patients who had undergone esophageal cancer resection at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, between 2013 and 2021, to collect their baseline data, and to classify patients into minimally invasive surgery and open surgery groups according to surgical modalities, and to match the propensity scores of patients in the two groups on the important baseline data, and to collect the postoperative recurrence of metastasis, survival, and the quality of life of the patients through the follow up visits To compare the long-term recurrence-free survival rate, overall survival rate and quality of life between the two groups, and to analyze the subgroups according to the type of esophageal cancer, pathological stage, and whether neoadjuvant therapy was performed, so as to explore more deeply the differences between minimally invasive esophagectomy and open esophagectomy in terms of postoperative long-term survival for patients with different types of esophageal cancers. And to analyze the influence of other baseline information on patients\' postoperative long-term survival and quality of life.
- Observed Indicators The main outcomes observed in this study were disease-free survival and overall survival after surgery.Survival was calculated: if the patient survived from the date of surgery to the date of follow-up, the survival period was from the date of surgery to the date of follow-up, and if the patient died between the date of surgery and the date of follow-up, the survival period was from the date of surgery to the date of death. Calculation of disease-free survival: from the date of surgery to the date of the first detection of recurrent metastatic disease between the date of surgery and the date of follow-up; the criterion for recurrence is the presence of metastases to other organs or lymph nodes after surgery confirmed by histology or imaging. Observation time: the patient\'s time from the first postoperative date to 5 full years postoperatively was taken as the observation time. Follow-up outcome: patient\'s death, loss to follow-up, or patient\'s survival at 5 full years postoperatively from the first postoperative date to 5 full years postoperatively were considered as the primary observation outcomes. Since the patients in this study were from patients who had undergone esophagectomy for esophageal cancer at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, during the period 2013-2021, the follow-up period was set at 3 years from the date of ethical approval - 3 years after the ethical approval was granted, which would allow all patients to reach the observation period of 5 years, and for cancer patients, the 3 and 5 year survival rates are very important prognostic data.
- Data collection Collection of patients\' baseline data: baseline data of patients who had undergone esophagectomy for esophageal cancer at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, and were successfully discharged from the hospital during the period from 2013 to 2021 were collected through the electronic medical record system, including, but not limited to, hospitalization number, name, gender, age, occupation, marital status, contact phone number, underlying disease, history of smoking and alcohol consumption, family history, PS score, body weight (kg), height (m ), ASA score, tumor site, date of surgery, duration of surgery (min), mode of surgery, intraoperative bleeding (ml), duration of surgery (min), blood routine, blood biochemistry, blood type, pathological results, lung function, postoperative course, and surgical complications. Collection of patients\' postoperative survival data: follow-up to collect patients\' postoperative survival data information, including, whether they were alive at the time of the follow-up date, the specific date of death, whether they died due to this disease, whether they had recurrent metastasis, the time of the first recurrent metastasis, and the information on the quality of postoperative survival, which was obtained according to the EORTC QLQ-OES18 quality of life questionnaire.
- Statistical analysis For the baseline data collected from patients, it was initially planned to use propensity score matching, with the minimally invasive surgery group and the open surgery group in a 1:1 ratio, so that the data of the two groups would be consistent in terms of baseline data; after obtaining the survival data of the patients in the postoperative period, the comparison of the continuous variables was performed using the Wilcoxon test/Mann Whitney U test or Student t-test, and the categorical variables were analyzed using the Pearson chi-square test or Fisher exact test. Categorical variables were reported as frequencies, percentages, and P values, and continuous variables were reported as means, ranges, and P values. The long-term recurrence-free survival and overall survival rates of the two groups and their 95% CIs were analyzed, and the hazard ratios of recurrence-free survival and overall survival and the differences between recurrence-free survival and overall survival were compared to see whether the differences were statistically significant; if the differences in the survival rates were statistically significant, there was a certain relationship between the long-term survival of esophageal cancer and the surgical modality, and if the differences were not statistically significant, it indicated that the two surgical In subgroup analysis, the long-term recurrence-free survival rate and overall survival rate and their 95% CIs were calculated for squamous carcinoma, adenocarcinoma, other malignant tumors, and different pathological stage subgroups, and the hazard ratios of the recurrence-free survival rate and overall survival rate and the differences between the recurrence-free survival rate and overall survival rate of the two groups were compared between the subgroups to see whether the differences were statistically significant or not, the difference was statistically significant for subgroups with statistically significant differences, indicating that there was a certain relationship between postoperative survival and surgery. statistically significant subgroups suggests that the choice of surgical modality can benefit patients with that characteristic, and thus there is a tendency to choose a more beneficial surgical modality for patients in clinical work. On the other hand, the EORTC QLQ-OES18 quality of life questionnaire classified the outcomes into 10 domains such as dysphagia, and by collecting information on the quality of life of surviving patients, we analyzed and compared whether there were differences in the quality of life of the two groups of patients in the different functional domains, so as to compare whether there was any effect of surgical modality on the quality of life of the patients in the postoperative period. Utilizing the available information, other factors were explored to find out whether there was any influence of other factors on postoperative survival and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive esophageal cancer resection group | – | –Surgical Procedures: minimally invasive esophagectomy |
| Open esophageal cancer resection group | – | –Surgical Procedures: open esophagectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had undergone esophageal cancer resection at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, between 2013 and 2021.
Key inclusion criteria (2 listed)
- Patients who had undergone esophageal cancer resection at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, between 2013 and 2021, with pathology results confirming esophageal squamous carcinoma, adenocarcinoma, or other malignant tumors.
- The surgery was successfully completed, the patient was safely discharged from the hospital, the postoperative follow-up was successful, and if the follow-up patient died, his or her death was due to natural causes.
Key exclusion criteria (1 listed)
- Perioperative patient deaths, pathologic findings other than those listed above, loss of visits, and postoperative unnatural deaths.
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
Survival Information
Time frame: From enrollment to 5 years after surgery
Dead or alive 5 years after surgery
score of Quality of life
Time frame: From enrollment to 5 years after surgery
Measured with EORTC QLQ-OES18 Quality of Life Questionnaire
1 secondary outcome
Recurrence or metastasis
Time frame: From enrollment to 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 32513211Li Z, Liu C, Liu Y, Yao S, Xu B, Dong G. Comparisons between minimally invasive and open esophagectomy for esophageal cancer with cervical anastomosis: a retrospective study. J Cardiothorac Surg. 2020 Jun 8;15(1):128. doi: 10.1186/s13019-020-01182-3.
- Background: PubMed 33987755Zheng Y, Li Y, Liu X, Sun H, Shen S, Ba Y, Wang Z, Liu S, Xing W. Minimally Invasive Versus Open McKeown for Patients with Esophageal Cancer: A Retrospective Study. Ann Surg Oncol. 2021 Oct;28(11):6329-6336. doi: 10.1245/s10434-021-10105-y. Epub 2021 May 13.
- Background: PubMed 35317621Ising MS, Smith SA, Trivedi JR, Martin RCG, Phillips P, Van Berkel V, Fox MP. Minimally Invasive Esophagectomy Is Associated with Superior Survival Compared to Open Surgery. Am Surg. 2023 May;89(5):1833-1843. doi: 10.1177/00031348221078962. Epub 2022 Mar 23.
- Background: PubMed 35303068Chen HS, Lin CH, Wu SC, Wang BY. Comparing survival between neoadjuvant chemoradiotherapy followed by open or thoracoscopic oesophagectomy in patients with oesophageal squamous cell carcinoma. Eur J Cardiothorac Surg. 2022 Jul 11;62(2):ezac114. doi: 10.1093/ejcts/ezac114.
- Background: PubMed 30308612van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LAA, Joore HCA, Kroese CC, Haj Mohammad N, Mook S, Vleggaar FP, Borel Rinkes IHM, Ruurda JP, van Hillegersberg R. Robot-assisted Minimally Invasive Thoracolaparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer: A Randomized Controlled Trial. Ann Surg. 2019 Apr;269(4):621-630. doi: 10.1097/SLA.0000000000003031.
- Background: PubMed 34230145Knitter S, Andreou A, Hofmann T, Chopra S, Denecke C, Thuss-Patience PC, Kroll D, Bahra M, Schmelzle M, Pratschke J, Biebl M. Minimally Invasive Versus Open Ivor-Lewis Esophagectomy for Esophageal Cancer or Cancer of the Gastroesophageal Junction: Comparison of Postoperative Outcomes and Long-term Survival Using Propensity Score Matching Analysis. Anticancer Res. 2021 Jul;41(7):3499-3510. doi: 10.21873/anticanres.15137.
- Background: PubMed 33480612Gottlieb-Vedi E, Kauppila JH, Mattsson F, Lindblad M, Nilsson M, Lagergren P, Rouvelas I, Lagergren J; FINEGO group. Long-term Survival in Esophageal Cancer After Minimally Invasive Esophagectomy Compared to Open Esophagectomy. Ann Surg. 2022 Dec 1;276(6):e744-e748. doi: 10.1097/SLA.0000000000004645. Epub 2021 Jan 20.
- Background: PubMed 35349668Giulini L, Dubecz A. Minimally invasive versus open oesophagectomy for cancer: propensity score analysis improves results' reliability but matching criteria need to be selected accurately. Eur J Cardiothorac Surg. 2022 Jul 11;62(2):ezac192. doi: 10.1093/ejcts/ezac192. No abstract available.
- 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.
Hui Tian, Doctor study director
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Cancer and Esophagectomy, run by Qilu Hospital of Shandong University at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Tian, Doctor (86 + 18560080016, tianhuiql@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Information (time frame: From enrollment to 5 years after surgery). The study lists 2 primary outcomes in all. 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 NCT06147180, which also lists 8 linked publications.
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 27 Nov 2023.