Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXijing Hospital of Digestive Diseases
About this trial
The incidence of esophagogastric junction has been increasing in recent years, and surgery is an important method for the treatment of adenoma at the esophagogastric junction. Currently, there is a great controversy about the surgical method of Siewert II, mainly choosing the right chest or the left chest for thoracic surgery. Therefore, it is of great significance to further study the surgical methods of Siewert II esophagogastric junction adenoma. Objective: To compare the safety, feasibility, and clinical efficacy of endoscopic Ivor-Lewis versus laparoscopic extended abdominal gastrectomy for Siewert type Ⅱadenocarcinoma at the resectable esophagogastric junction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed EGJ type II adenocarcinoma
Pretreatment stage CT1-4A, N0-3, M0
For cT4a stage patients, their resectable properties must be clearly verified before randomization
For locally advanced tumors (CT3-T4 or N+), all 4 cycles of chemotherapy (FLOT) were completed before surgery.
Disqualifiers
Histologically confirmed EGJ type I and III adenocarcinoma
Tumor spread over 5 cm proximal to EGJ
Clinically significant (active) heart disease (i.e. symptomatic coronary artery disease or myocardial infarction within the last 12 months) resulting in left ventricular ejection fraction<50%(determined by echocardiography)
Clinically significant lung diseases (forced expiratory volume in 1 second (FEV1)<1.5 l/s)
Trial design
Design model
Parallel
Treatments tested in this trial
Endoscopy Ivor-lewis
Procedure/SurgeryEndoscopy Ivor-lewis
Laparoscopic transabdominal enlarged gastrectomy
Procedure/SurgeryLaparoscopic transabdominal enlarged gastrectomy
Treatment groups
212 Participants
are divided into 2 treatment groupsGroup A: The experimental groupExperimental treatment 1 intervention
Group B: The control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disease-free survival time
The time from the date of surgery to the patient's death from any cause
Time frame
three yearsSecondary outcomes
1
Overall survival
The time from the date of surgery to the patient's death from any cause
Time frame
five years2
Incidence of postoperative complications
Postoperative complications include anastomotic fistula (clinically or radiologically diagnosed); Respiratory complications (defined as clinical manifestations of pneumonia or bronchopneumonia, confirmed by computed tomography); Cardiovascular complications (defined as persistent arrhythmias requiring treatment); Chylothorax (defined as white fluid in thoracic drainage after enteral nutrition); Wound infection; And other complications (delayed empty. pleural effusion, recurrent nerve injury)
Time frame
a month3
Postoperative mortality
Postoperative mortality is defined as the proportion of deaths from any cause
Time frame
a month4
Tumor recurrence
Tumor recurrence
Time frame
three yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xijing Hospital of Digestive Diseases
Lead sponsor
Tang-Du Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
General Hospital of Ningxia Medical University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
Source ClinicalTrials.gov