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Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction

Primary Purpose

Siewert Type II Adenocarcinoma of Esophagogastric Junction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopy Ivor-lewis
Laparoscopic transabdominal enlarged gastrectomy
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Siewert Type II Adenocarcinoma of Esophagogastric Junction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed EGJ type II adenocarcinoma

    ··The tumor can be removed by laparoscopy through the gastrodiaphragmatic esophageal hiatus or by endoscopic Ivor Lewis operation

  • 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.
  • 18 to 75 years old
  • ECOG score 0-2
  • ASA <4
  • Good bone marrow function (leukocyte > x 10 ^ 9 / l; Hemoglobin> 9 g/dl. ·Platelet>100×10^9/ L), renal function (glomerular filtration rate & GT; 60ml/min) and liver function (total bilirubin &lt; 1.5 times normal (ULN), aspartate aminotransferase (AST< 2.5x ULN, Alanine aminotransferase (ALT)<3 x ULN)
  • Patients and their family members voluntarily sign written informed consent

Exclusion Criteria:

  • 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)
  • Pregnant women and nursing mothers
  • Stump gastric cancer
  • Borrmann Type 4 (Leather stomach)
  • Simultaneous or heterochronous malignant tumors of other organs except carcinoma in situ of the cervix and adenoma and focal colorectal carcinoma
  • Right thoracotomy or history of right pleural adhesion
  • Cirrhosis, or indocyanine green test ≥15% of chronic liver disease
  • No seizure control, central nervous system diseases or mental disorders
  • History of upper abdominal surgery (except laparoscopic cholecystectomy)
  • The patient has coagulation dysfunction and cannot be corrected
  • Patients with heart, lung, liver, brain, kidney and other important organ failure
  • Patients with metabolic diseases such as diabetes
  • Immunosuppressive therapy, such as organ transplantation, SLE, etc
  • Seriously out of control recurrent infections or other seriously out of control concomitant diseases
  • Other diseases requiring simultaneous surgery
  • Diseases requiring emergency surgery due to tumor emergencies (e.g. hemorrhage, perforation, obstruction)

Sites / Locations

  • LiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The experimental group

The control group

Arm Description

Endoscopic ivor-Lewis operation was performed for siwert type II adenoma at the esophagogastric junction

Laparoscopic transabdominal enlarged gastrectomy for siwert TYPE II adenoma at the esophagogastric junction was performed

Outcomes

Primary Outcome Measures

Disease-free survival time
The time from the date of surgery to the patient's death from any cause

Secondary Outcome Measures

Overall survival
The time from the date of surgery to the patient's death from any cause
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)
Postoperative mortality
Postoperative mortality is defined as the proportion of deaths from any cause
Tumor recurrence
Tumor recurrence

Full Information

First Posted
April 27, 2022
Last Updated
June 7, 2022
Sponsor
Xijing Hospital of Digestive Diseases
Collaborators
Tang-Du Hospital, Henan Provincial People's Hospital, General Hospital of Ningxia Medical University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Shanxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05356520
Brief Title
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
Official Title
A Multicenter Randomized Controlled Study of Siewert II Esophagogastric Junction Adenocarcinoma With Endoscopic Ivor-Lewis Approach Versus Laparoscopic Transabdominal Extended Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases
Collaborators
Tang-Du Hospital, Henan Provincial People's Hospital, General Hospital of Ningxia Medical University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Shanxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
At present, the main surgical approaches for the treatment of esophagogastric junction adenocarcinoma include single left thoracic incision, 2 right epigastric incisions, 2 left epigastric incisions, 3 cervicothoracoabdominal incisions, and left thoracoabdominal combined incision and esophageal rift through the diaphragm. Siewert type I ESOPHAgogastric junction carcinoma recommends a right thoracic approach, including Ivor-LEIws and McKeown, according to the Chinese Expert consensus for surgical treatment of ESOPHAgogastric junction adenocarcinoma published in 2018. Siwert TYPE III adenoma at esophagogastric junction, esophageal hiatus through diaphragmatic approach is recommended. The surgical approach for siwert type II adenoma at the esophagogastric junction is controversial [7,8]. Due to the particularity of siWERT type II lymph node diffusion, it can spread to both posterior mediastinal lymph nodes and abdominal lymph nodes, and a simple esophageal hiatus through the diaphragm may not be enough to clear lymph nodes. Does a combined thoracoabdominal approach improve patient outcomes? In the 1990s and early 2000s, the Japanese Clinical Oncology Organization (JCOG) compared the efficacy of different surgical approaches for esophagogastric junction adenocarcinoma. The trial randomized patients to transesophageal hiatus or left thoracoabdominal combined approach. Results The incidence of postoperative pneumonia was significantly higher in the left thoracoabdominal approach group than in the transesophageal hiatus group (13%vs. 4%, P=0.048), there was no significant difference in the survival rate of Siewert II type ESOPHAgogastric junction tumor between the two groups (P=0.496). To provide the best, targeted treatment for patients with esophagogastric junction adenocarcinoma, radical resection of the tumor should be combined with resection of adjacent lymph nodes. Previous studies have shown that the effect of surgery on the right chest is better than that on the left. Therefore, we asked whether the endoscopic Ivor-Lewis approach was better than the laparoscopic transabdominal enlarged gastrectomy. The right thoracic approach is the recommended approach for siwert type I adenoma at the esophagogastric junction. It has obvious advantages in postoperative esophageal and cardiopulmonary function protection. Currently, there are no clinical trials of endoscopic Ivor-Lewis and laparoscopic extended abdominal gastrectomy for the treatment of siwert type II adenoma at the esophagogastric junction. Endoscopic IVOR-Lewis and laparoscopic transesophageal hiatus test provide new clinical data for the treatment of siwert TYPE II adenoma at the esophagogastric junction, and help standardize the treatment of siwert type II adenoma at the esophagogastric junction. Therefore, based on our experience and foundation of gastrointestinal surgery in the treatment of esophagogastric junction tumors, through practical observation and research on clinical experimental treatment plans, and integration of domestic superior resources, the establishment and improvement of treatment standards for esophagogastric junction adenoma will be further promoted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Siewert Type II Adenocarcinoma of Esophagogastric Junction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The experimental group
Arm Type
Experimental
Arm Description
Endoscopic ivor-Lewis operation was performed for siwert type II adenoma at the esophagogastric junction
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
Laparoscopic transabdominal enlarged gastrectomy for siwert TYPE II adenoma at the esophagogastric junction was performed
Intervention Type
Procedure
Intervention Name(s)
Endoscopy Ivor-lewis
Intervention Description
Endoscopy Ivor-lewis
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic transabdominal enlarged gastrectomy
Intervention Description
Laparoscopic transabdominal enlarged gastrectomy
Primary Outcome Measure Information:
Title
Disease-free survival time
Description
The time from the date of surgery to the patient's death from any cause
Time Frame
three years
Secondary Outcome Measure Information:
Title
Overall survival
Description
The time from the date of surgery to the patient's death from any cause
Time Frame
five years
Title
Incidence of postoperative complications
Description
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 month
Title
Postoperative mortality
Description
Postoperative mortality is defined as the proportion of deaths from any cause
Time Frame
a month
Title
Tumor recurrence
Description
Tumor recurrence
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed EGJ type II adenocarcinoma ··The tumor can be removed by laparoscopy through the gastrodiaphragmatic esophageal hiatus or by endoscopic Ivor Lewis operation 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. 18 to 75 years old ECOG score 0-2 ASA <4 Good bone marrow function (leukocyte > x 10 ^ 9 / l; Hemoglobin> 9 g/dl. ·Platelet>100×10^9/ L), renal function (glomerular filtration rate & GT; 60ml/min) and liver function (total bilirubin &lt; 1.5 times normal (ULN), aspartate aminotransferase (AST< 2.5x ULN, Alanine aminotransferase (ALT)<3 x ULN) Patients and their family members voluntarily sign written informed consent Exclusion Criteria: 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) Pregnant women and nursing mothers Stump gastric cancer Borrmann Type 4 (Leather stomach) Simultaneous or heterochronous malignant tumors of other organs except carcinoma in situ of the cervix and adenoma and focal colorectal carcinoma Right thoracotomy or history of right pleural adhesion Cirrhosis, or indocyanine green test ≥15% of chronic liver disease No seizure control, central nervous system diseases or mental disorders History of upper abdominal surgery (except laparoscopic cholecystectomy) The patient has coagulation dysfunction and cannot be corrected Patients with heart, lung, liver, brain, kidney and other important organ failure Patients with metabolic diseases such as diabetes Immunosuppressive therapy, such as organ transplantation, SLE, etc Seriously out of control recurrent infections or other seriously out of control concomitant diseases Other diseases requiring simultaneous surgery Diseases requiring emergency surgery due to tumor emergencies (e.g. hemorrhage, perforation, obstruction)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaohua Li, MD,PH.D
Phone
+8613474299901
Email
xjyylixiaohua@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
zhenchang Mo
Phone
+8618700816920
Email
mzc131208@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaohua li, MD,PH.D
Organizational Affiliation
Xijing Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
xianli he, MD,PH.D
Organizational Affiliation
Tang-Du Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
peichun sun, MD,PH.D
Organizational Affiliation
Henan Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
lei wang, MD,PH.D
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
xuejun sun, MD,PH.D
Organizational Affiliation
First Affiliated Hospital of Xi 'an Jiaotong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
he huang, MD,PH.D
Organizational Affiliation
The First Affiliated Hospital of Shanxi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaohua li, MD,PH.D
Phone
13474299901
Email
xjyylixiaohua@163.com

12. IPD Sharing Statement

Learn more about this trial

Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction

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