Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer (RDG)

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

The purpose of this study is to explore the clinical outcomes of the robotic distal gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.

Study Overview

• Status: Completed
• Conditions: Robotic Surgery; Stomach Neoplasm
• Intervention / Treatment: Procedure: Robotic Distal Gastrectomy; Procedure: Laparoscopic Distal Gastrectomy

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 distal gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic distal gastrectomy in the treatment of gastric adenocarcinoma （cT1-4a, N-/+, M0）.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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 dissction to obtain R0 resection sugicall results.
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) 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 ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )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. FEV1<50% of the predicted values

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Distal Gastrectomy; Robotic Distal Gastrectomy will be performed for the treatment of patients assigned to this group.	Procedure: Robotic Distal Gastrectomy; After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.
Active Comparator: Laparoscopic Distal Gastrectomy; Laparoscopic Distal Gastrectomy will be performed for the treatment of patients assigned to this group.	Procedure: Laparoscopic Distal Gastrectomy; After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival rate	the rate of 3-year overall survival rate	36 months
Time to first ambulation	Time to first ambulation in hours is used to assess the postoperative recovery course.	30 days
Time to first flatus	Time to first flatus in days is used to assess the postoperative recovery course.	30 days
Time to first liquid diet	Time to first liquid diet in days is used to assess the postoperative recovery course.	30 days
Time to first soft diet	Time to first soft diet in days is used to assess the postoperative recovery course.	30 days
Duration of postoperative hospital stay	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days
intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 day
overall postoperative serious morbidity rates	Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher	30 days
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.	30 days
3-year recurrence pattern	the pattern of recurrence in 3 years	36 months
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.	3, 6, 9 and 12 months
Hospitalization expenses	The cost from admission to discharge	30 days
number of retrieved lymph nodes	number of retrieved lymph nodes	1 days
the noncompliance rate of lymphadenectomy	the noncompliance rate of lymphadenectomy	1 days
The variation of cholesterol	The variation of cholesterol in millimole/liter 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 album	The variation of album in gram/liter 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	The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 5 are recorded to access the inflammatory response.	Preoperative 7 days and postoperative 1 and 5 days
The variation of hemoglobin	The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 5 are recorded to access the inflammatory response.	Preoperative 7 days and postoperative 1 and 5 days
operation time	operation time	1 days

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Changming Huang, Professor, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 14, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Robotic Surgery; Stomach Neoplasm; Distal Gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2017-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No