Trial Title:
Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy
NCT ID:
NCT06147180
Condition:
Esophagus Cancer
Esophagectomy
Quality of Life
Survival
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
esophagus Cancer
invasive esophagectomy
open esophagectomy
long-term survival
quality of life
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
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' 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' 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' 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'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.
4. 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.
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.
Criteria for eligibility:
Study pop:
Patients who had undergone esophageal cancer resection at the Department of Thoracic
Surgery, Qilu Hospital, Shandong University, between 2013 and 2021.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Ji'nan
Zip:
250012
Country:
China
Investigator:
Last name:
Tui Tian
Email:
Principal Investigator
Investigator:
Last name:
Zhanpeng Tang
Email:
Sub-Investigator
Investigator:
Last name:
Junjie Liu
Email:
Sub-Investigator
Start date:
November 27, 2023
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06147180
