search
Back to results

Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Primary Purpose

Gastric Cancer, Robotic Gastrectomy

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total Robotic Distal Gastrectomy
Robotic-Assisted Distal Gastrectomy
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, robotic assisted distal gastrectomy, total robotic distal gastrectomy

Eligibility Criteria

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

Inclusion Criteria:

  1. Age from over 18 to under 75 years
  2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  3. cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  4. expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
  5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  6. American Society of Anesthesiology (ASA) class I to III
  7. Written informed consent

Exclusion Criteria:

  1. Women during pregnancy or breast-feeding
  2. Severe mental disorder
  3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  4. History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
  5. Gastric multiple primary carcinoma
  6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
  7. History of other malignant disease within the past 5 years
  8. History of previous neoadjuvant chemotherapy or radiotherapy
  9. History of unstable angina or myocardial infarction within the past 6 months
  10. History of cerebrovascular accident within the past 6 months
  11. History of continuous systematic administration of corticosteroids within 1 month
  12. Requirement of simultaneous surgery for other disease
  13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  14. Forced expiratory volume in 1 second (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

Total Robotic Distal Gastrectomy

Robotic-Assisted Distal Gastrectomy

Arm Description

After exploration and randomization, patients received total robotic distal gastrectomy

After exploration and randomization, patients received robotic-assisted distal gastrectomy.

Outcomes

Primary Outcome Measures

Morbidity rates
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.

Secondary Outcome Measures

3-year disease free survival rate
3-year disease free survival rate
3-year overall survival rate
3-year overall survival rate
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
overall postoperative serious morbidity rates
Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
Total Number of Retrieved Lymph Nodes
Total Number of Retrieved Lymph Nodes
postoperative recovery course
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
postoperative nutritional status
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
inflammatory immune response
The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response
Time of digestive tract reconstruction
From the beginning to the end of digestive tract reconstruction

Full Information

First Posted
March 4, 2021
Last Updated
March 10, 2021
Sponsor
Fujian Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04795063
Brief Title
Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Official Title
Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2027 (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
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).
Detailed Description
In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Robotic Gastrectomy
Keywords
Gastric Cancer, robotic assisted distal gastrectomy, total robotic distal gastrectomy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Total Robotic Distal Gastrectomy
Arm Type
Experimental
Arm Description
After exploration and randomization, patients received total robotic distal gastrectomy
Arm Title
Robotic-Assisted Distal Gastrectomy
Arm Type
Active Comparator
Arm Description
After exploration and randomization, patients received robotic-assisted distal gastrectomy.
Intervention Type
Procedure
Intervention Name(s)
Total Robotic Distal Gastrectomy
Intervention Description
All the surgical procedures are performed using the robot system.
Intervention Type
Procedure
Intervention Name(s)
Robotic-Assisted Distal Gastrectomy
Intervention Description
After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.
Primary Outcome Measure Information:
Title
Morbidity rates
Description
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
3-year disease free survival rate
Description
3-year disease free survival rate
Time Frame
36 months
Title
3-year overall survival rate
Description
3-year overall survival rate
Time Frame
36 months
Title
3-year recurrence pattern
Description
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time Frame
36 months
Title
intraoperative morbidity rates
Description
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time Frame
1 day
Title
overall postoperative serious morbidity rates
Description
Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
Time Frame
30 days
Title
Total Number of Retrieved Lymph Nodes
Description
Total Number of Retrieved Lymph Nodes
Time Frame
1 day
Title
postoperative recovery course
Description
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
postoperative nutritional status
Description
The variation of weight 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
inflammatory immune response
Description
The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
Time of digestive tract reconstruction
Description
From the beginning to the end of digestive tract reconstruction
Time Frame
1 day

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 cT1-4a (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 distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale American Society of Anesthesiology (ASA) 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 Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) 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 Forced expiratory volume in 1 second (FEV1)<50% of the predicted values
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-ming Huang, MD
Phone
+86-13805069676
Email
hcmlr2002@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qi-yue Chen, PhD
Phone
+86-15980235636
Email
690934662@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-ming Huang, MD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changming Huang, M.D., Ph.D.
Phone
+86-133-6591-0253
Email
hcmlr2002@163.com
First Name & Middle Initial & Last Name & Degree
Changming Huang, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

We'll reach out to this number within 24 hrs