Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

March 10, 2021 updated by: Chang-Ming Huang, Prof., Fujian Medical University

Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
        • Contact:
          • Changming Huang, M.D., Ph.D.
          • Phone Number: +86-133-6591-0253
          • Email: hcmlr2002@163.com
        • Principal Investigator:
          • Changming Huang, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total Robotic Distal Gastrectomy
After exploration and randomization, patients received total robotic distal gastrectomy
Procedure: Total Robotic Distal Gastrectomy
All the surgical procedures are performed using the robot system.
Active Comparator: Robotic-Assisted Distal Gastrectomy
After exploration and randomization, patients received robotic-assisted distal gastrectomy.
Procedure: Robotic-Assisted Distal Gastrectomy
After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity rates
Time Frame: 30 days
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year recurrence pattern
Time Frame: 36 months
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
36 months
3-year disease free survival rate
Time Frame: 36 months
3-year disease free survival rate
36 months
3-year overall survival rate
Time Frame: 36 months
3-year overall survival rate
36 months
intraoperative morbidity rates
Time Frame: 1 day
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
1 day
overall postoperative serious morbidity rates
Time Frame: 30 days
Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
30 days
Total Number of Retrieved Lymph Nodes
Time Frame: 1 day
Total Number of Retrieved Lymph Nodes
1 day
postoperative recovery course
Time Frame: 30 days
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
30 days
postoperative nutritional status
Time Frame: 3, 6, 9 and 12 months
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
3, 6, 9 and 12 months
inflammatory immune response
Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
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
Preoperative 3 days and postoperative 1, 3, and 5 days
Time of digestive tract reconstruction
Time Frame: 1 day
From the beginning to the end of digestive tract reconstruction
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Study Chair: Chang-Ming Huang, MD, Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUGES-022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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