Dataset Information

Right versus left thoracic approach oesophagectomy for oesophageal cancer: a systematic review and meta-analysis protocol.

ABSTRACT:

Introduction

Oesophageal cancer is one of the most common malignant tumours and has been identified as one of the leading causes of cancer death worldwide. Surgery is considered to be the optimal treatment for patients with resectable oesophageal cancer. Oesophagectomy for oesophageal cancer can significantly extend the survival period of patients and provide a potential opportunity for a cure. However, there is still controversy regarding which thoracic approach (right or left) during oesophagectomy for oesophageal cancer can lead to better surgical outcomes globally. This systematic review and meta-analysis will be performed to determine which thoracic approach during oesophagectomy will achieve longer patient survival and will be more beneficial for patients.

Methods and analysis

We will search PubMed, Web of Science, Embase, Cancerlit, the Cochrane Central Register of Controlled Trials and Google Scholar databases for relevant clinical trials published in any language before 1 October 2019. Randomised controlled trials (RCTs), quasi-RCTs, propensity score-matched comparative studies and prospective cohort studies of interest, published or unpublished, that meet the inclusion criteria will be included. Subgroup analysis of the type of operation, tumour pathological stage and ethnicity will be performed.

Prospero registration number

CRD42019124133.

Ethics and dissemination

Because this study will be based on published or unpublished records and studies, there is no need for ethics approval. The results of the study will be published in a peer-reviewed journal.

SUBMITTER: Chai T

PROVIDER: S-EPMC6629400 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

Right versus left thoracic approach oesophagectomy for oesophageal cancer: a systematic review and meta-analysis protocol.

Chai Tianci T Shen Zhimin Z Chen Sui S Lin Yuhan Y Zhang Zhenyang Z Lin Wenwei W Hong Junjie J Yang Chuangcai C Kang Mingqiang M Lin Jiangbo J

BMJ open 20190709 7

<h4>Introduction</h4>Oesophageal cancer is one of the most common malignant tumours and has been identified as one of the leading causes of cancer death worldwide. Surgery is considered to be the optimal treatment for patients with resectable oesophageal cancer. Oesophagectomy for oesophageal cancer can significantly extend the survival period of patients and provide a potential opportunity for a cure. However, there is still controversy regarding which thoracic approach (right or left) during o ...[more]

PMID: 31289096

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Project description:BackgroundLeft thoracic approach (LTA) has been a favorable selection in surgical treatment for esophageal cancer (EC) patients in China before minimally invasive esophagectomy (MIE) is popular. This study aimed to demonstrate whether right thoracic approach (RTA) is superior to LTA in the surgical treatment of middle and lower thoracic esophageal squamous cell carcinoma (TESCC).MethodsSuperiority clinical trial design was used for this multicenter randomized controlled two-parallel group study. Between April 2015 and December 2018, cT1b-3N0-1M0 TESCC patients from 14 centers were recruited and randomized by a central stratified block randomization program into LTA or RTA groups. All enrolled patients were followed up every three months after surgery. The software SPSS 20.0 and R 3.6.2. were used for statistical analysis. Efficacy and safety outcomes, 3-year overall survival (OS) and disease-free survival (DFS) were calculated and compared using the Kaplan-Meier method and the log-rank test.ResultsA total of 861 patients without suspected upper mediastinal lymph nodes (umLN) were finally enrolled in the study after 95 ineligible patients were excluded. 833 cases (98.7%) were successfully followed up until June 1, 2020. Esophagectomies were performed via LTA in 453 cases, and via RTA in 408 cases. Compared with the LTA group, the RTA group required longer operating time (274.48±78.92 vs. 205.34±51.47 min, P<0.001); had more complications (33.8% vs. 26.3% P=0.016); harvested more lymph nodes (LNs) (23.61±10.09 vs. 21.92±10.26, P=0.015); achieved a significantly improved OS in stage IIIa patients (67.8% vs. 51.8%, P=0.022). The 3-year OS and DFS were 68.7% and 64.3% in LTA arm versus 71.3% and 63.7% in RTA arm (P=0.20; P=0.96).ConclusionsEsophagectomies via both LTA and RTA can achieve similar outcomes in middle or lower TESCC patients without suspected umLN. RTA is superior to LTA and recommended for the surgical treatment of more advanced stage TESCC due to more complete lymphadenectomy.Trial registrationClinicalTrials.gov NCT02448979.

Project description:IntroductionOesophageal cancer is the eighth most common cause of cancer worldwide. In 2009 in China, the incidence and death rate of oesophageal cancer was 22.14 per 100 000 person-years and 16.77 per 100 000 person-years, respectively, the highest in the world. Minimally invasive oesophagectomy (MIO) was introduced into clinical practice with the aim of reducing the morbidity rate. The mechanisms of MIO may lie in minimising the reaction to surgical injury and inflammation. There are some randomised trials regarding minimally invasive versus open oesophagectomy, with 100-850 subjects enrolled. To date, no large randomised controlled trial comparing minimally invasive versus open oesophagectomy has been reported in China, where squamous cell carcinoma predominated over adenocarcinoma of the oesophagus.Methods and analysisThis is a 3 year multicentre, prospective, randomised, open and parallel controlled trial, which aims to compare the effectiveness of minimally invasive thoraco-laparoscopic oesophagectomy to open three-stage transthoracic oesophagectomy for resectable oesophageal cancer. Group A patients receive MIO which involves thoracoscopic oesophagectomy and laparoscopic gastric mobilisation with cervical anastomosis. Group B patients receive the open three-stage transthoracic oesophagectomy which involves a right thoracotomy and laparotomy with cervical anastomosis. Primary endpoints include respiratory complications within 30 days after operation. The secondary endpoints include other postoperative complications, influences on pulmonary function, intraoperative data including blood loss, operative time, the number and location of lymph nodes dissected, and mortality in hospital, the length of hospital stay, total expenses in hospital, mortality within 30 days, survival rate after 2 years, postoperative pain, and health-related quality of life (HRQoL). Three hundred and twenty-four patients in each group will be needed and a total of 648 patients will finally be enrolled into the study.Ethics and disseminationThe study protocol has been approved by the Institutional Ethics Committees of all participating institutions. The findings of this trial will be disseminated to patients and through peer-reviewed publications and international presentations.Trial registration numberNCT02355249.

Project description:BackgroundSurgery is the gold standard treatment for local advanced disease, while definitive concurrent chemoradiotherapy (DCRT) is recommended for those who are medically unable to tolerate major surgery or medically fit patients who decline surgery. The primary aim of this trial is to compare the outcomes in Chinese patients with oesophageal squamous cell cancer with locally advanced resectable disease who have received either surgery or DCRT.Methods/designOne hundred ninety-six patients with T1bN + M0 or T2-4aN0-2 M0 oesophageal squamous cell cancer will be randomised to the DCRT group or the surgery group. In the DCRT group, patients will be given intensity-modulated radiation therapy (IMRT) with 50 Gy/25 fractions and basic chemotherapy with 5-fluorouracil regimens. In the surgery group, patients will receive neoadjuvant chemoradiotherapy (NCRT) and standard oesophagectomy. Five years of follow-up will be scheduled for patients. The primary endpoints are 2-year/5-year overall survival; the secondary endpoints are 2-year/5-year progression-free survival, treatment-related adverse events and the patients' quality of life. The main evaluation methods include oesophagoscopy, endoscopic ultrasonography and biopsy, oesophageal barium meal, computed tomography, positron emission tomography-computed tomography, blood tests and questionnaires.DiscussionThe preponderant oesophageal cancer pathology type is dramatically different in western Caucasian and Asian oesophageal cancer patients: Caucasian patients present with 80% adenocarcinomas, and Asians patients present with 95% squamous cell carcinomas. This phenomenon needs more in-depth studies to elucidate the differences in these populations. Based on the results of this study, we will show whether DCRT will benefit patients more than oesophagectomy. This study will contribute more evidence to the management of oesophageal squamous cell cancer.Trial registrationClinicalTrials.gov, NCT02972372 . Registered on 26 November 2016.

Project description:Background Oesophageal cancer is the eighth most common cause of cancer worldwide. In recent years, the frequency to use minimally invasive surgical methods for esophagectomy has been increased, but its real advantages over conventional surgery is still remains. The aim of this study is to compare patients who underwent open three-stage transthoracic oesophagectomy with those who underwent minimally invasive thoraco-laparoscopic oesophagectomy (MIO) to ascertain the feasibility, safety, and clinical advantages of the MIO. Methods We did a multicentre prospective, open and parallel, randomised controlled trial in six study centres between April 1st, 2014, and April 30th, 2018. Patients aged 18–75 years with resectable middle and upper esophageal cancer were randomly assigned via a computer-generated randomisation sequence to receive either open three-stage transthoracic oesophagectomy (Group A) or MIO (Group B). The perioperative outcomes were to compare operative time, intraoperative blood loss, total expenses in hospital, hospital stay, the number and location of lymph nodes harvested and respiratory complications within 30 days. This trial is registered with ClinicalTrials.gov Identifier: NCT02355249. Results We randomly assigned 339 patients to the Group A and 156 to the Group B. No differences emerged in terms of age (year) [(61.52±8.52) vs. (60.25±6.28), P=0.67], the median lengths of hospital stay (day) [(16.28±8.02) vs. (17.15±11.74), P=0.08]. Group A has less intraoperative blood loss (mL) [(241.1±165.8) vs. (274.0±169.8), P<0.05] and total expenses in hospital (?) [(92,076±27,889) vs. (107,669±32,655), P<0.05], shorter operative time (min) [(267±92.2) vs. (364.3±99.43), P<0.05]. While Group B has palpable advantage in the number [(18.30±11.44) vs. (23.08±12.45), P<0.05] and location [(4.30±2.16) vs. (5.44±2.37), P<0.05] of lymph nodes harvested. The proportion of respiratory complications within 30 days was no statistical difference in the Group B [21/156 (13.5%)] compared to the Group A [45/339 (13.3%)] (Chi-square sig =0.934, P>0.05). Meanwhile, the study makes clear that tumour size has no correlation to operative time (Spearman r =?0.014, P>0.05) and intraoperative blood loss (Spearman r =0.078, P>0.05). Conclusions Compared to open three-stage transthoracic oesophagectomy, MIO has prominent representation in lymph nodes harvested which is fatal to estimate prognosis and plan sequential treatment plan, although, MIO has some disadvantage such as longer operative time, more intraoperative blood loss and total expenses in hospital which is conflicting to previous observational studies conclusion. There is no statistical difference in respiratory complications within 30 days between the two surgical approaches. Next step, survival rate after 2 years will be analyzed and published after the follow-up work is finished.

Dataset Information

Right versus left thoracic approach oesophagectomy for oesophageal cancer: a systematic review and meta-analysis protocol.

Introduction

Methods and analysis

Prospero registration number

Ethics and dissemination

Publications

Right versus left thoracic approach oesophagectomy for oesophageal cancer: a systematic review and meta-analysis protocol.

Similar Datasets

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