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

Primary Purpose

Stomach Neoplasm, Robotic Surgery

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

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring Stomach Neoplasm, Robotic Surgery, Total Gastrectomy

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 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

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic Assisted Total Gastrectomy

Laparoscopic Assisted Total Gastrectomy

Arm Description

Robotic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.

Laparoscopic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.

Outcomes

Primary Outcome Measures

3-year disease free survival rate
the rate of 3-year disease free survival

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2018
Last Updated
February 4, 2020
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03524300
Brief Title
Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
Official Title
Prospective Randomized Controlled Trial for Comparison of Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2024 (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

5. Study Description

Brief Summary
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
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））.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm, Robotic Surgery
Keywords
Stomach Neoplasm, Robotic Surgery, Total Gastrectomy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Robotic Assisted Total Gastrectomy
Arm Type
Experimental
Arm Description
Robotic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
Arm Title
Laparoscopic Assisted Total Gastrectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
Intervention Type
Procedure
Intervention Name(s)
Robotic Assisted Total Gastrectomy
Intervention Description
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total gastrectomy will be performed in the experimental group.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Assisted Total Gastrectomy
Intervention Description
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental group.
Primary Outcome Measure Information:
Title
3-year disease free survival rate
Description
the rate of 3-year disease free survival
Time Frame
36 months
Secondary Outcome Measure Information:
Title
3-year overall survival rate
Description
the rate of 3-year overall survival rate
Time Frame
36 months
Title
3-year recurrence pattern
Description
the pattern of recurrence in 3 years
Time Frame
36 months
Title
overall postoperative morbidity rates
Description
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Time Frame
30 days
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
Time to first ambulation
Description
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Time to first flatus
Description
Time to first flatus in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Time to first liquid diet
Description
Time to first liquid diet in days is used to assess the postoperative recovery course
Time Frame
30 days
Title
Time to first soft diet
Description
Time to first soft diet in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Duration of postoperative hospital stay
Description
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
The variation of weight
Description
The variation of weight in kilograms 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
The variation of white blood cell count
Description
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.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
Hospitalization expenses
Description
The cost from admission to discharge
Time Frame
30 days
Title
operation time
Description
operation time
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changming Huang, Professor
Phone
+86-138-0506-9676
Email
hcmlr2002@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mi Lin, M.D.
Phone
+86-134-5915-2658
Email
170894572@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changming Huang, Professor
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
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changming Huang, Professor
Phone
8613805069676
Email
hcmlr2002@163.com
First Name & Middle Initial & Last Name & Degree
Ruhong Tu, M.D
Phone
8615980278081
Email
794561137@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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