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Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG

Primary Purpose

Esophagogastric Junction Adenocarcinoma

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robotic Assisted AEG Radical Gastrectomy
Laparoscopic Assisted AEG Radical Gastrectomy
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagogastric Junction Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Age from over 18 to under 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • Expected to perform total gastrectomy with D2+No.19+No.20 lymph node dissction to obtain R0 resection sugicall results.
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) class I to III
  • Written informed consent

Exclusion Criteria:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
  • Gastric multiple primary carcinoma
  • Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
  • History of other malignant disease within the past 5 years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within the past 6 months
  • History of cerebrovascular accident within the past 6 months
  • History of continuous systematic administration of corticosteroids within 1 month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of the predicted values

Sites / Locations

  • Fujian Medical University Union Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic Assisted AEG Radical Gastrectomy

Laparoscopic Assisted AEG Radical Gastrectomy

Arm Description

Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma

Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma

Outcomes

Primary Outcome Measures

3-year disease free survival rate
3-year disease free survival rate

Secondary Outcome Measures

3-year overall survival rate
3-year overall survival rate
3-year recurrence pattern
3-year recurrence pattern
overall postoperative morbidity rates
overall postoperative morbidity rates
intraoperative morbidity rates
intraoperative morbidity rates
overall postoperative serious morbidity rates
overall postoperative serious morbidity rates
number of retrieved lymph nodes
number of retrieved lymph nodes
Time to first ambulation
Time to first ambulation is used to access the postoperative recovery course.
Time to first flatus
Time to first flatus is used to access the postoperative recovery course.
Time to first liquid diet
Time to first liquid diet is used to access the postoperative recovery course.
Time to soft diet
Time to soft diet is used to access the postoperative recovery course.
Duration of hospital stay
Duration of hospital stay is used to access the postoperative recovery course.
The amount of abdominal drainageare
The amount of abdominal drainageare is used to access the postoperative recovery course.
postoperative nutritional status
Weight and height will be combined to report BMI in kg/m^2. The variation of BMI in kg/m^2 on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Hospitalization costs
Hospitalization costs

Full Information

First Posted
October 20, 2019
Last Updated
February 4, 2020
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04153058
Brief Title
Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG
Official Title
Randomized Controlled Trials on Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

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
The purpose of this study is to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma（cT2-4a, N-/+, M0）
Detailed Description
In recent years, the incidence of gastric cancer has been decreasing year by year in the world, but the incidence of adenocarcinoma of the esophagogastric junction (AEG) has shown a significant upward trend, especially in Western countries such as Europe and the United States. The prognosis of AEG is poor, therefore, it is extremely necessary to establish AEG's best diagnosis and treatment strategies to improve the long-term outcome of AEG. Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma (cT2-4a, N-/+, M0) by comparing with laparoscopic assisted.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Robotic Assisted AEG Radical Gastrectomy
Arm Type
Experimental
Arm Description
Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
Arm Title
Laparoscopic Assisted AEG Radical Gastrectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
Intervention Type
Procedure
Intervention Name(s)
Robotic Assisted AEG Radical Gastrectomy
Intervention Description
Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Assisted AEG Radical Gastrectomy
Intervention Description
Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
Primary Outcome Measure Information:
Title
3-year disease free survival rate
Description
3-year disease free survival rate
Time Frame
36 months
Secondary Outcome Measure Information:
Title
3-year overall survival rate
Description
3-year overall survival rate
Time Frame
36 months
Title
3-year recurrence pattern
Description
3-year recurrence pattern
Time Frame
36 months
Title
overall postoperative morbidity rates
Description
overall postoperative morbidity rates
Time Frame
30 days
Title
intraoperative morbidity rates
Description
intraoperative morbidity rates
Time Frame
1 day
Title
overall postoperative serious morbidity rates
Description
overall postoperative serious morbidity rates
Time Frame
30 days
Title
number of retrieved lymph nodes
Description
number of retrieved lymph nodes
Time Frame
14 days
Title
Time to first ambulation
Description
Time to first ambulation is used to access the postoperative recovery course.
Time Frame
30 days
Title
Time to first flatus
Description
Time to first flatus is used to access the postoperative recovery course.
Time Frame
30 days
Title
Time to first liquid diet
Description
Time to first liquid diet is used to access the postoperative recovery course.
Time Frame
30 days
Title
Time to soft diet
Description
Time to soft diet is used to access the postoperative recovery course.
Time Frame
30 days
Title
Duration of hospital stay
Description
Duration of hospital stay is used to access the postoperative recovery course.
Time Frame
30 days
Title
The amount of abdominal drainageare
Description
The amount of abdominal drainageare is used to access the postoperative recovery course.
Time Frame
30 days
Title
postoperative nutritional status
Description
Weight and height will be combined to report BMI in kg/m^2. The variation of BMI in kg/m^2 on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Time Frame
3, 6, 9 and 12 months
Title
Hospitalization costs
Description
Hospitalization costs
Time Frame
30 days

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: Age from over 18 to under 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition Expected to perform total gastrectomy with D2+No.19+No.20 lymph node dissction to obtain R0 resection sugicall results. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer) Gastric multiple primary carcinoma Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging History of other malignant disease within the past 5 years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within the past 6 months History of cerebrovascular accident within the past 6 months History of continuous systematic administration of corticosteroids within 1 month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of the predicted values
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Ming Huang
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG

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