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A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG

Primary Purpose

Esophagogastric Junction Adenocarcinoma, Siewert Type II Adenocarcinoma of Esophagogastric Junction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagogastric Junction Adenocarcinoma

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent of patients;
  • The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).
  • The endoscopic biopsy was diagnosed with adenocarcinoma;
  • Preoperative clinical staging was cT1-4aNanyM0
  • No distant metastasis and invasion of surrounding organs were found;
  • ECOG score ranged from 0 to 1;
  • ASA score ranged from I to III.

Exclusion Criteria:

  • Pregnant or lactating women
  • Have a severe mental illness
  • History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer)
  • History of other malignant tumors within 5 years
  • History of unstable angina pectoris or myocardial infarction within 6 months
  • FEV1% of pulmonary function test was less than 50% of expected value
  • History of cerebral infarction or cerebral hemorrhage within 6 months
  • Have severe liver and kidney damage

Sites / Locations

  • Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Research group

Arm Description

Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy.

Outcomes

Primary Outcome Measures

The incidences of early perioperative complications
The early perioperative complications include anastomotic fistula, anastomotic stenosis, gastrointestinal dysfunction, chest or abdominal infection, chest or abdominal hemorrhage, respiratory complications, cardiovascular and cerebrovascular accidents, embolism and so on.
Perioperative mortality
The incidence of death due to the surgery

Secondary Outcome Measures

Duration of operation
The time it takes to complete the operation
Intraoperative blood loss
Total blood lost during surgery
The rate of transit thoracotomy or laparotomy
Thoracic or abdominal incisions greater than 10cm are considered to be converted to open chest or abdomen.
Intraoperative mortality
The rate of death during the surgery.
Proximal marginal distance
The length of proximal tumor from esophageal resection margin.
The number of mediastinal lymph node dissections and the positive
The mediastinal lymph nodes include NO.19,NO.20,NO.105,NO.106,NO.107,NO.108,NO.109,N0.110,NO.111,NO.112.
The number of abdominal lymph node dissections and the positive
The abdominal lymph nodes include NO.1,NO.2,NO.3,NO.4,NO.5,NO.6,NO.7,NO.8,NO.9,NO.10,NO.11,NO.12,NO.13,NO.14.
The tumor type
Such as squamous cell carcinoma, adenocarcinoma, etc.
The pathological stage
Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer
The duration of first exhaust
The duration from the end of the operation to the first exhaust after the operation.
The duration of first defecation
The duration from the end of the operation to the first defecation after the operation.
The duration of first leaving the bed
The duration from the end of the operation to the first leaving the bed after the operation.
The duration of restoration of full flow diet
The duration from the end of the operation to restore to a full-flow diet after the operation.
The duration of restoration of half-flow diet
The duration from the end of the operation to restore to a half-flow diet after the operation.
The duration of removal of chest drainage tube
The duration from the end of the operation to remove the chest drainage tube after the operation.
The duration of postoperative hospitalization
The duration from the end of the operation to hospital discharge.
3-year overall survival rate
Overall survival rate during 3 years after surgery
3-year disease-free survival rate
Disease-free survival rate during 3 years after surgery
5-year overall survival rate
Overall survival rate during 5 years after surgery
5-year disease-free survival rate
Disease-free survival rate during 5 years after surgery

Full Information

First Posted
March 26, 2020
Last Updated
June 7, 2020
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04423354
Brief Title
A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG
Official Title
A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

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

5. Study Description

Brief Summary
Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of esophagogastric junction. Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the eligibility criteria will be included in the study and undergo the transthoracic single-hole assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed. Primary study endpoints: The incidences of early postoperative complications and mortality. The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year disease-free survival and overall survival.
Detailed Description
Surgery and oncology indicators,such as length of operation, intraoperative blood loss, transit thoracotomy or laparotomy rate, length of proximal tumor from esophageal resection margin, number of mediastinal lymph node dissections and the positive, number of abdominal lymph node dissections and the positive, tumor type and pathological stage, etc.; Early postoperative recovery information ,such as time of first exhaust and defecation, time of leaving the bed, time of recovery of full and half-flow diet, time of removal of chest drainage tube, time of postoperative hospitalization, etc.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Research group
Arm Type
Experimental
Arm Description
Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy.
Intervention Type
Procedure
Intervention Name(s)
Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
Intervention Description
Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company.
Primary Outcome Measure Information:
Title
The incidences of early perioperative complications
Description
The early perioperative complications include anastomotic fistula, anastomotic stenosis, gastrointestinal dysfunction, chest or abdominal infection, chest or abdominal hemorrhage, respiratory complications, cardiovascular and cerebrovascular accidents, embolism and so on.
Time Frame
Within 30 days after surgery
Title
Perioperative mortality
Description
The incidence of death due to the surgery
Time Frame
Within 30 days after surgery
Secondary Outcome Measure Information:
Title
Duration of operation
Description
The time it takes to complete the operation
Time Frame
From the beginning of anesthesia to the completion of surgery
Title
Intraoperative blood loss
Description
Total blood lost during surgery
Time Frame
From the beginning of anesthesia to the completion of surgery
Title
The rate of transit thoracotomy or laparotomy
Description
Thoracic or abdominal incisions greater than 10cm are considered to be converted to open chest or abdomen.
Time Frame
From the beginning of anesthesia to the completion of surgery
Title
Intraoperative mortality
Description
The rate of death during the surgery.
Time Frame
From the beginning of anesthesia to the completion of surgery
Title
Proximal marginal distance
Description
The length of proximal tumor from esophageal resection margin.
Time Frame
From the beginning of anesthesia to the completion of surgery
Title
The number of mediastinal lymph node dissections and the positive
Description
The mediastinal lymph nodes include NO.19,NO.20,NO.105,NO.106,NO.107,NO.108,NO.109,N0.110,NO.111,NO.112.
Time Frame
About 7 days.
Title
The number of abdominal lymph node dissections and the positive
Description
The abdominal lymph nodes include NO.1,NO.2,NO.3,NO.4,NO.5,NO.6,NO.7,NO.8,NO.9,NO.10,NO.11,NO.12,NO.13,NO.14.
Time Frame
About 7 days.
Title
The tumor type
Description
Such as squamous cell carcinoma, adenocarcinoma, etc.
Time Frame
About 7 days.
Title
The pathological stage
Description
Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer
Time Frame
About 7 days.
Title
The duration of first exhaust
Description
The duration from the end of the operation to the first exhaust after the operation.
Time Frame
Time from end of surgery to discharge,about 7 days.
Title
The duration of first defecation
Description
The duration from the end of the operation to the first defecation after the operation.
Time Frame
Time from end of surgery to discharge,about 7 days.
Title
The duration of first leaving the bed
Description
The duration from the end of the operation to the first leaving the bed after the operation.
Time Frame
Time from end of surgery to discharge,about 7 days.
Title
The duration of restoration of full flow diet
Description
The duration from the end of the operation to restore to a full-flow diet after the operation.
Time Frame
Time from end of surgery to discharge,about 7 days.
Title
The duration of restoration of half-flow diet
Description
The duration from the end of the operation to restore to a half-flow diet after the operation.
Time Frame
Time from end of surgery to discharge,about 7 days.
Title
The duration of removal of chest drainage tube
Description
The duration from the end of the operation to remove the chest drainage tube after the operation.
Time Frame
Time from end of surgery to discharge,about 7 days.
Title
The duration of postoperative hospitalization
Description
The duration from the end of the operation to hospital discharge.
Time Frame
Time from end of surgery to discharge,about 7 days.
Title
3-year overall survival rate
Description
Overall survival rate during 3 years after surgery
Time Frame
3 years after surgery
Title
3-year disease-free survival rate
Description
Disease-free survival rate during 3 years after surgery
Time Frame
3 years after surgery
Title
5-year overall survival rate
Description
Overall survival rate during 5 years after surgery
Time Frame
5 years after surgery
Title
5-year disease-free survival rate
Description
Disease-free survival rate during 5 years after surgery
Time Frame
5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent of patients; The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ). The endoscopic biopsy was diagnosed with adenocarcinoma; Preoperative clinical staging was cT1-4aNanyM0 No distant metastasis and invasion of surrounding organs were found; ECOG score ranged from 0 to 1; ASA score ranged from I to III. Exclusion Criteria: Pregnant or lactating women Have a severe mental illness History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer) History of other malignant tumors within 5 years History of unstable angina pectoris or myocardial infarction within 6 months FEV1% of pulmonary function test was less than 50% of expected value History of cerebral infarction or cerebral hemorrhage within 6 months Have severe liver and kidney damage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wei wang, M.D.,Ph.D
Phone
+86-13922255515
Email
ww1640@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
yuling xue, M.M.
Phone
+86-15014167320
Email
xueyuling1994@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wei wang, M.D.,Ph.D
Organizational Affiliation
Guangdong PHTCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang, M.D.,PH.D.
Phone
+86-13922255515
Email
wangwei16400@163.com
First Name & Middle Initial & Last Name & Degree
Wenjun Xiong, M.D.
Phone
+86-15920553177
Email
xiongwj1988@163.com
First Name & Middle Initial & Last Name & Degree
Wei Wang
First Name & Middle Initial & Last Name & Degree
Jin Wan
First Name & Middle Initial & Last Name & Degree
Wen jun Xiong
First Name & Middle Initial & Last Name & Degree
Yan sheng Zheng
First Name & Middle Initial & Last Name & Degree
Li jie Luo
First Name & Middle Initial & Last Name & Degree
Jin Li

12. IPD Sharing Statement

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A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG

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