Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147180
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-11-19
Brief Title:
Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 patients39 long-term survival after surgery
Detailed Description:
1 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 patients39 long-term survival and quality of life after surgery using the available data
2 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 patients39 postoperative long-term survival and quality of life
3 Observed Indicators The main outcomes observed in this study were disease-free survival and overall survival after surgerySurvival 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 patient39s time from the first postoperative date to 5 full years postoperatively was taken as the observation time Follow-up outcome patient39s death loss to follow-up or patient39s 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
4 Data collection Collection of patients39 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 patients39 postoperative survival data follow-up to collect patients39 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
5 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 11 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 testMann 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
2 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 patients39 postoperative long-term survival and quality of life
3 Observed Indicators The main outcomes observed in this study were disease-free survival and overall survival after surgerySurvival 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 patient39s time from the first postoperative date to 5 full years postoperatively was taken as the observation time Follow-up outcome patient39s death loss to follow-up or patient39s 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
4 Data collection Collection of patients39 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 patients39 postoperative survival data follow-up to collect patients39 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
5 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 11 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 testMann 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None