Clinical trial NCT06147180: Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophagus Cancer
Esophagectomy
Quality of Life
Survival
Keywords: esophagus Cancer
invasive esophagectomy
open esophagectomy
long-term survival
quality of life
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 1474
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had undergone esophageal cancer resection at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, between 2013 and 2021.

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 patients\&#39; 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 patients\&#39; 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 patients\&#39; 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 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\&#39;s time from the first postoperative date to 5 full years postoperatively was taken as the observation time. Follow-up outcome: patient\&#39;s death, loss to follow-up, or patient\&#39;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.
4. Data collection Collection of patients\&#39; 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\&#39; postoperative survival data: follow-up to collect patients\&#39; 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 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

Perioperative patient deaths, pathologic findings other than those listed above, loss of visits, and postoperative unnatural deaths.

Primary outcomes:
measure: Survival Information
timeFrame: From enrollment to 5 years after surgery
measure: score of Quality of life
timeFrame: From enrollment to 5 years after surgery
Secondary outcomes:
measure: Recurrence or metastasis
timeFrame: From enrollment to 5 years after surgery
Other outcomes:
Locations:
city: Ji'nan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Hui Tian, Doctor
role: STUDY_DIRECTOR
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