Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Esophageal Cancer

minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation.

open gastric mobilization and gastric tube formation

In the MIE group the laparoscopic procedure was performed for gastric tube formation. The patient was placed in supine position with legs apart. The surgeon stands between the legs using a five-trocar technique. Laparoscopy will be followed by an anterolateral thoracotomy in the fourth intercostal space.

minimally invasive esophagectomy

in the open group the gastric mobilization and gastric tube formation will be perfumed with an open surgical approach. Laparotomy will be performed, followed by an anterolateral thoracotomy in the fourth intercostal space.

open esophagectomy

The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the minimally invasive approach with the standard open procedure regarding morbidity and mortality.

Esophageal resection is still associated with considerable morbidity and mortality. Standardized preoperative efforts could increase the outcome of these patients. While early reports of medical pioneers focused particularly on safety and feasibility, more recent studies showed that implementation of minimally invasive esophagectomy (MIE) was widely accepted. Since first reports of MIE, different techniques and adjustments have been discussed. A recent publication of a large prospective trial in Phase II showed the safety of a total minimally invasive approach (video assisted thoracoscopic surgery (VATS) and laparoscopy). Surgical technique however is still a subject of debate and the level of evidence remains still low. Proving feasibility does not warrant a paradigm shift, as experience is an important factor for safety and patient benefit.

The aim of this study was to evaluate morbidity and mortality of open esophagectomy (OE) versus hybrid-MIE in a randomized controlled setting.

Prior to surgery patients will be randomized either the minimally invasive surgery group (laparoscopic gastric tube formation and thoracotomy) or the the open surgery group (open gastric tube formation with an open laparotomy approach). Randomizing tool is the "randomizer" of the medical university of vienna. (link is attached below)

Morbidity in Open Versus Minimally Invasive Esophagectomy

Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy

anastomotic leakage, gastric conduit necrosis and/or pneumonia

length of stay at the intensive care unit (ICU)

Austrian Society Of Surgical Oncology

Behaviors and Mental Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Quality of Life

Surgical Procedures: minimally invasive esophagectomy

Hui Tian, Doctor

Junjie Liu

Tui Tian

Zhanpeng Tang

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.

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.

Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy

Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy for Esophageal Cancer: a Retrospective Cohort Study

Measured with EORTC QLQ-OES18 Quality of Life Questionnaire

Qilu Hospital of Shandong University

Analgesics

All Drugs and Chemicals

This is a prospective non-randomized study comprising two surgical cohorts of esophageal cancer patients. Patients will be assigned to each of the two intervention groups, MIE versus OE, based on a combination of patient referral patterns, patient preference, and surgeon preference/expertise.

Initial pre-operative assessment post-operative assessment in-hospital assessment at first post-operative visit (clinic visits, or by telephone or mail) assessments at 4, 8, 12, 18, and 24 months post-operatively (+/- 2 month window). For patients who have their surgery delayed, they may be asked to complete another, more updated set of pre-surgery surveys. For the dysphagia score and CT Scan vs EUS subset will be a dysphagia questionnaire, administered at the time of the initial clinic visit.

Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log

Matthew Bott, MD

The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's quality of life over time. The investigators hope this study will provide important information that can be used to improve the quality of life of patients with esophageal cancer. This study will also look at how standard tests and information collected from the patients difficulty swallowing can predict the extent of their esophageal cancer before surgery.

Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer

To evaluate whether a combination of a dysphagia score of 2-4 and a specific CT scan maximal tumor thickness. the patient's CT scan (either performed elsewhere or at MSK) will be reviewed by one radiologist, who will assess the maximal thickness of tumor involvement (\>=cm). Patients will then undergo their planned a staging Endoscopic ultrasonography (EUS) by the gastroenterology service, at which time the EUS depth of invasion will be assigned. The dysphagia score and CT thickness will then be compared to the EUS depth (considered the 'gold standard')

the patient's CT scan (either performed elsewhere or at MSK) will be reviewed by one radiologist, who will assess the maximal thickness of tumor involvement (\>=cm). Patients will then undergo their planned staging Endoscopic ultrasonography (EUS) by the gastroenterology service, at which time the EUS depth of invasion will be assigned. The dysphagia score and CT thickness will then be compared to the EUS depth (considered the 'gold standard')

Pain intensity (average of the four pain severity items) measured by BPI at Post-op Days 1 and 3, after epidural removal, at first post-operative clinic visit, at 4 months

FACT-E score at the post-op visit and at the 4 months

Pain intensity assessed by BPI at 8 months, 12 months, 18 months, 24 months (average of the four pain severity items) Presence of symptoms with intensity ≥3, as assessed by the Symptom Assessment Scale at post-op visit, at 4 months visit (adjusted for pre-operative symptom intensity )

FACT- E score at 8 months, 12 months, 18 months, 24 months. Presence of symptoms with intensity ≥3, assessed by the Symptom Assessment Scale at 8 months, 12 months, 18 months, 24 months

operative time, estimated blood loss, length of hospital stay, ICU admission rates, ICU days, complication type, rates and severity as determined by the Common Terminology Criteria for Adverse Events (CTCAE) utilized by MSKCC, rate of anastomotic leak, rate of anastomotic stricture, 90-day (post-operative) hospital readmission rates, time to oral intake, and time to first ambulation.

Memorial Sloan Kettering Cancer Center

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Deglutition Disorders

Heartburn

Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.

Questionnaires

Julie A Ward, BSN

Julie A. Ward, BSN

James D. Luketich, MD

Neil A. Christie, MD

Arjun Pennathur, MD

Matthew Schuchert, MD

Manisha Shende, MD

Lawrence Crist, MD

Ryan Levy, MD

Omar Awais, DO

Kevin McGrath, MD

Angela Gallagher, CRNP

Rajeev Dhupar, MD

Inderpal Sarkaria, MD

Nicholas Baker, MD

William Gooding

Daniel Neto, MD

Tadeusz Witek, MD

James D Luketich, MD

To assess short and long term outcomes after minimally invasive esophagectomy compared to open esophagectomy. To compare both standard outcome measures as well as patient derived outcome measures, in particular, quality of life (QOL). To look at the applicability of this QOL instrument to this patient group.

Assess short and long term outcomes after minimally invasive esophagectomy(MIE) compared to open esophagectomy. Measure standard observer derived outcomes such as morbidity, mortality, tumor recurrence and also patient derived outcomes, in particular quality of life (QOL) using the MOS SF36 questionnaire. Evaluate whether the SF36 will accurately reflect pre and postoperative changes in clinical status in this patient group.Compare the results of this global QOL instrument (SF 36) to disease specific scales of dysphagia and reflux. Assess the impact of adjuvant or neoadjuvant therapy on QOL in this patient group and determine if any advantages of MIE can be demonstrated.

Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life

The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.

University of Pittsburgh

Wounds and Injuries

Surgical Wound

Treated by traditional three-incision esophagectomy in the centers with enough experience in esophagectomy via right thoracotomy and the volume ≧50 cases each year.

treated by minimally invasive thorascopic/laparoscopic esophagectomy in the centers with enough experience in VATS esophagectomy and the volume≧50 cases each year.

Minimally invasive esophagectomy

Yousheng Mao, MD

Zhirong Zhang, MD

Jie He, MD,PhD

Esophageal carcinoma is an aggressive malignancy with poor prognosis. Surgical resection remains the most effective method for this malignant disease. VATS esophagectomy has become more and more popular in China and around the world. Although VATS esophagectomy has been proven to be effective in preventing respiratory complications, there is still no ample evidences to demonstrate that VATS esophagectomy is as effective as traditional three-incision esophagectomy in lymph node dissection and is equal or superior in long-term survival. The purpose of this large scale prospective observational study is to compare the minimally invasive thorascopic/laparoscopic esophagectomy with traditional three-incision esophagectomy in lymph node dissection, postoperative recovery, postoperative complications, and long-term survival.

Esophageal carcinoma is an aggressive malignancy with poor prognosis,For these patients, radical esophagectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor. However, the percentage of cardiopulmonary complications associated with the traditional three-incision esophagectomy is high.Recent studies have shown that the minimally invasive thorascopic and laparoscopic esophagectomy is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes,including reduced blood loss, shorter ICU stay,and lower pulmonary complication rate, but the evidence is not ample because the sample size is not enough.The objective of this study is to compare the efficacy, perioperative complications, lymph node dissection and long term survival between the thoracic esophageal cancer patients treated by minimally invasive thorascopic/laparoscopic esophagectomy and open transthoracic esophagectomy by three incisions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Morbidity in Open Versus Minimally Invasive Esophagectomy	NCT03035071	Esophageal Canc...	minimally invas... open esophagect...	18 Years - 80 Years	Austrian Society Of Surgical Oncology
Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy	NCT06147180	Esophagus Cance... Esophagectomy Quality of Life Survival		-	Qilu Hospital of Shandong University
Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer	NCT01558648	Esophageal Canc...	Quality of Life... Quality of Life...	18 Years -	Memorial Sloan Kettering Cancer Center
Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy	NCT06147180	Esophagus Cance... Esophagectomy Quality of Life Survival		-	Qilu Hospital of Shandong University
Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life	NCT00260559	Esophagectomy Esophageal Canc...	Questionnaires	18 Years -	University of Pittsburgh
Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic and Laparoscopic Esophagectomy	NCT02448966	Esophageal Canc...	open esophagect... Minimally invas...	18 Years - 75 Years	ChineseAMS

Spots Global Cancer Trial Database for open esophagectomy