Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Fujian Medical University

Status: Not yet enrolling

Conditions: Gastric Cancer; Robotic Gastrectomy

Treatments: Procedure: Total Robotic Distal Gastrectomy; Procedure: Robotic-Assisted Distal Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04795063

FUGES-022

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Total Robotic Distal Gastrectomy

Experimental group

Description:

After exploration and randomization, patients received total robotic distal gastrectomy

Treatment:

Procedure: Total Robotic Distal Gastrectomy

Robotic-Assisted Distal Gastrectomy

Active Comparator group

Description:

After exploration and randomization, patients received robotic-assisted distal gastrectomy.

Treatment:

Procedure: Robotic-Assisted Distal Gastrectomy