Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Not Applicable

Not yet recruiting

• Conditions: Gastric Cancer; Robotic Gastrectomy
• Interventions: Procedure: Total Robotic Distal Gastrectomy; Procedure: Robotic-Assisted Distal Gastrectomy

• Registration Number: NCT04795063
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-01
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-10
• Study First Posted: 2021-03-12
• Last Update Posted: 2021-03-12
• Primary Completion: 2024-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Robotic Distal Gastrectomy	Total Robotic Distal Gastrectomy	After exploration and randomization, patients received total robotic distal gastrectomy
Robotic-Assisted Distal Gastrectomy	Robotic-Assisted Distal Gastrectomy	After exploration and randomization, patients received robotic-assisted distal gastrectomy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
3-year overall survival rate	36 months	3-year overall survival rate
3-year disease free survival rate	36 months	3-year disease free survival rate
3-year recurrence pattern	36 months	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	1 day	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
overall postoperative serious morbidity rates	30 days	Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
Total Number of Retrieved Lymph Nodes	1 day	Total Number of Retrieved Lymph Nodes
postoperative recovery course	30 days	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
postoperative nutritional status	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.
inflammatory immune response	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
Time of digestive tract reconstruction	1 day	From the beginning to the end of digestive tract reconstruction

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China