Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer

February 4, 2020 updated by: Chang-Ming Huang, Prof., Fujian Medical University

Prospective Randomized Controlled Trial for Comparison of Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer

The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 total gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic assisted total gastrectomy in the treatment of clinical Stage I gastric adenocarcinoma （cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0））.

Study Type

Interventional

Enrollment (Anticipated)

220

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

  • Name: Changming Huang, Professor
  • Phone Number: +86-138-0506-9676
  • Email: hcmlr2002@163.com

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
        • Contact:

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:

  • 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 cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 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:

  • cStage IIA or more advaned at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • Multiple primary cancer
  • 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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Robotic Assisted Total Gastrectomy
Robotic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
Procedure: Robotic Assisted Total Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total gastrectomy will be performed in the experimental group.
ACTIVE_COMPARATOR: Laparoscopic Assisted Total Gastrectomy
Laparoscopic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic Assisted Total Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease free survival rate
Time Frame: 36 months
the rate of 3-year disease free survival
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival rate
Time Frame: 36 months
the rate of 3-year overall survival rate
36 months
Time to first ambulation
Time Frame: 30 days
Time to first ambulation in hours is used to assess the postoperative recovery course.
30 days
Time to first flatus
Time Frame: 30 days
Time to first flatus in days is used to assess the postoperative recovery course.
30 days
Time to first soft diet
Time Frame: 30 days
Time to first soft diet in days is used to assess the postoperative recovery course.
30 days
Duration of postoperative hospital stay
Time Frame: 30 days
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
30 days
operation time
Time Frame: 1 day
operation time
1 day
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 morbidity rates
Time Frame: 30 days
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
30 days
3-year recurrence pattern
Time Frame: 36 months
the pattern of recurrence in 3 years
36 months
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
Time to first liquid diet
Time Frame: 30 days
Time to first liquid diet in days is used to assess the postoperative recovery course
30 days
The variation of weight
Time Frame: 3, 6, 9 and 12 months
The variation of weight in kilograms on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
3, 6, 9 and 12 months
The variation of white blood cell count
Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory response.
Preoperative 3 days and postoperative 1, 3, and 5 days
Hospitalization expenses
Time Frame: 30 days
The cost from admission to discharge
30 days

Collaborators and Investigators

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

Sponsor

Fujian Medical University

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 (ACTUAL)

June 1, 2018

Primary Completion (ANTICIPATED)

November 30, 2021

Study Completion (ANTICIPATED)

November 30, 2024

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (ACTUAL)

May 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUGES-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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