Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic and Laparoscopic Esophagectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Two-field Versus Three-field Lymphadenectomy in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement

NCT02448953

Esophageal Cancer

UNKNOWN NA

Perioperative Management and Outcomes of Minimally Invasive Esophagectomy

NCT03378869

Esophageal Cancer

COMPLETED

Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer

NCT05514769

Proximal Gastric Adenocarcinoma Gastric Cancer Gastroesophageal Reflux Disease

RECRUITING NA

Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

NCT05446441

Thyroid Cancer

UNKNOWN NA

Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy

NCT05199168

Esophageal Cancer

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Traditional open esophagectomy

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

open esophagectomy

Intervention Type PROCEDURE

Minimally invasive eophagectomy

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

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

open esophagectomy

Intervention Type PROCEDURE

Minimally invasive esophagectomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients with histologically proven squamous cell esophageal cancer, without any previous anti-tumor therapy;
2. Preoperative clinical TNM stage:cT1b-3N0-1M0;
3. Adequate cardiopulmonary, liver, brain and kidney function which can tolerate the esophagectomy either via traditional tree-incision or minimally invasive thorascopic/laparoscopic esophagectomy;
4. Preoperative assessment by CT and EUS is fit for minimally invasive thorascopic/laparoscopic esophagectomy;
5. Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail.

Exclusion Criteria

1. Previous use of anti-cancer therapy;
2. Preoperative clinical TNM stage: N2-3 or M1;
3. Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
4. Previous malignancy history;
5. Unwilling to participate the clinical trial and refuse to sign informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No