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Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction

Primary Purpose

Adenocarcinoma of Esophagogastric Junction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transhiatal/transabdominal approach
thoracoabdominal approach
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of Esophagogastric Junction

Eligibility Criteria

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

Inclusion Criteria:

  • 1.18~75 years old
  • 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) .
  • 3.Histological diagnosis of adenocarcinoma
  • 4. American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3
  • 5.Informed consent of patients

Exclusion Criteria:

  • 1.Patients with distant metastasis (M1) or invasion of surrounding organs
  • 2.History of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer)
  • 3.History of other malignant tumors within 5 years
  • 4.The researcher believes that the patient is not suitable to participate in the clinical trial
  • 5.Patients who persist in withdrawing from clinical trials

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thoracoabdominal approach

Transhiatal/transabdominal approach

Arm Description

Radical surgery should be finished via Thoracoabdominal approach.

Radical surgery should be finished via transhiatal/transabdominal approach.

Outcomes

Primary Outcome Measures

3-year disease-free survival
Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up

Secondary Outcome Measures

The rate of R0-resection
The proportion of patients undergoing radical resection in all surgical patients
The number of lymph node dissections and the positive
The number of lymph node dissections and the positive
The duration of postoperative hospitalization
Time from end of surgery to discharge
The incidences of early postoperative complications
The incidence of postoperative complications such as pneumonia, pleural effusion, anastomotic stenosis, anastomotic leakage, duodenal stump fistula, pancreatic fistula, abdominal abscess, and deep vein thrombosis (%).
The incidence of perioperative mortality
The incidence of death due to the surgery

Full Information

First Posted
May 20, 2021
Last Updated
May 29, 2021
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04910789
Brief Title
Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction
Official Title
A Prospective, Multicenter, Randomized, Controlled Study Comparing Surgical Efficacy Between Transhiatal/Transabdominal and Thoracoabdominal Approach for Patients With Siewert II Adenocarcinoma of Esophagogastric Junction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction
Detailed Description
Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert Ⅱ adenocarcinoma of esophagogastric junction. Methods: A prospective, multi-center, randomized, controlled study will be performed. Patients who meet the eligibility criteria will be registered in the study and undergo radical surgery via transhiatal/transabdominal or thoracoabdominal approach. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed. The primary endpoints :3-year disease-free survival. The secondary endpoints:(1) Surgery and oncology indicators ;(2) The incidences of postoperative complications and mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracoabdominal approach
Arm Type
Experimental
Arm Description
Radical surgery should be finished via Thoracoabdominal approach.
Arm Title
Transhiatal/transabdominal approach
Arm Type
Active Comparator
Arm Description
Radical surgery should be finished via transhiatal/transabdominal approach.
Intervention Type
Procedure
Intervention Name(s)
transhiatal/transabdominal approach
Intervention Description
Radical surgery should be finished via transhiatal/transabdominal approach
Intervention Type
Procedure
Intervention Name(s)
thoracoabdominal approach
Intervention Description
Radical surgery should be finished via thoracoabdominal approach
Primary Outcome Measure Information:
Title
3-year disease-free survival
Description
Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up
Time Frame
3 years after surgery
Secondary Outcome Measure Information:
Title
The rate of R0-resection
Description
The proportion of patients undergoing radical resection in all surgical patients
Time Frame
About 10 days after surgery
Title
The number of lymph node dissections and the positive
Description
The number of lymph node dissections and the positive
Time Frame
About 10 days after surgery
Title
The duration of postoperative hospitalization
Description
Time from end of surgery to discharge
Time Frame
Within 6 months after surgery
Title
The incidences of early postoperative complications
Description
The incidence of postoperative complications such as pneumonia, pleural effusion, anastomotic stenosis, anastomotic leakage, duodenal stump fistula, pancreatic fistula, abdominal abscess, and deep vein thrombosis (%).
Time Frame
Within 30 days after surgery
Title
The incidence of perioperative mortality
Description
The incidence of death due to the surgery
Time Frame
Within 30 days after surgery

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: 1.18~75 years old 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) . 3.Histological diagnosis of adenocarcinoma 4. American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3 5.Informed consent of patients Exclusion Criteria: 1.Patients with distant metastasis (M1) or invasion of surrounding organs 2.History of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer) 3.History of other malignant tumors within 5 years 4.The researcher believes that the patient is not suitable to participate in the clinical trial 5.Patients who persist in withdrawing from clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinxin Wang, Dr
Phone
+8613811858199
Email
301wxx@sina.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinxin Wang, Dr.
Phone
+8613811858199
Email
301wxx@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35331180
Citation
Song Q, Li X, Wu D, Li S, Xie T, Lu Y, Zhang L, Xu Z, Liu L, Guo X, Wang X. The abdominal-transhiatal surgical approach versus the thoracoabdominal surgical approach in Siewert type II adenocarcinoma of the esophagogastric junction: protocol for a multicenter prospective, open, parallel, and randomized controlled trial. BMC Cancer. 2022 Mar 24;22(1):318. doi: 10.1186/s12885-022-09375-w.
Results Reference
derived

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Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction

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