Clinical trial NCT03273920: Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
Official title: Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: laparoscopy-assisted gastrectomy
robot-assisted gastrectomy
advanced gastric cancer
D2 Lymphadenectomy
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: West China Hospital
name: Xijing Hospital of Digestive Diseases
name: Nanjing PLA General Hospital
name: Peking University Cancer Hospital & Institute
name: Qingdao University
name: Fujian Medical University Union Hospital
name: Central South University
name: The First Affiliated Hospital of Nanchang University
name: Sun Yat-sen University
name: Wuhan Union Hospital, China
name: Jilin Provincial Tumor Hospital
name: Lanzhou General Hospital of PLA
First posted: 2017-09-06
Enrollment: 1110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an investigator-initiated, randomized, controlled, parallel group, and non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.

Detailed description: Since the first case of laparoscopy-assisted distal gastrectomy was reported in 1994, the number of patients undergoing the laparoscopic procedure has gradually increased. The latest Japanese gastric cancer treatment guideline recommends laparoscopic gastrectomy (LG) as an optional treatment for cStage I gastric cancer (GC). Based on the experience of early GC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC). According to the results of large-scaled retrospective studies and ongoing randomized controlled trials (RCTs), LG treating AGC can gain better short-term outcomes and comparable long-term oncologic results.

To minimize the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages. Though the feasibility and safety of robotic gastrectomy (RG) have been well accepted, the benefits of RG remain controversial. A recent meta-analysis including eleven studies of 3503 patients demonstrated that RG indicated potentially favorable outcomes in terms of blood loss compared with LG. Furthermore, it has been confirmed that robotic system could provide an advantage over LG in the dissection of the N2 area lymph nodes, especially around the splenic artery area. Our previous study demonstrated that the RG had less intraoperative blood loss and more lymph nodes dissection compared with the laparoscopic procedure. However, the only prospective study reported that RG is not superior to LG in terms of perioperative surgical outcomes. Nevertheless, the following subgroup analysis found that patients with GC undergoing D2 lymph node dissection can benefit from less blood loss when a robotic surgery system is used. Take together, RG with D2 nodal dissection may be superior laparoscopic surgery in terms of blood loss and retrieved lymph nodes. However, lack of high-level evidence-based medical researches, we can't drew a conclusion that patients with AGC may benefit from RG with D2 nodal dissection.

With regard to a new surgical approach, oncologic safety has attracted more attention. Although some retrospective studies have demonstrated that RG with lymphadenectomy for GC had non-inferior oncologic outcome relative to LG, there is no prospective RCT to evaluate the long-term outcomes of RG. Therefore, the Chinese Robotic Gastrointestinal Surgery Study (CRASS) Group launched a multicenter prospective RCT to verify the short-term and long-term outcomes of RG in AGC. The primary objective of this study is to assess whether robot-assisted distal gastrectomy is comparable to laparoscopic approach in terms of long-term oncologic outcomes without compromising relapse-free survival. The secondary research objectives are to compare robotic and laparoscopic approach in terms of morbidity, mortality, quality of life, cost-effectiveness, and overall survival.

Eligibility criteria: Inclusion Criteria:

1. Pathologically proven gastric adenocarcinoma.
2. Tumor located in the lower third of the stomach, and is possible to be curatively resected by subtotal gastrectomy.
3. Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. American Society of Anesthesiology (ASA) score of class I to III
6. Patients who freely give informed consent to participate in the clinical study

Exclusion Criteria:

1. Previous upper abdominal surgery (except laparoscopic cholecystectomy)
2. Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)
3. Gastric cancer-related complications (complete obstruction or perforation)
4. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging
5. Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer
6. Patients diagnosed with other malignancy within 5 years
7. Severe mental disorder
8. Unstable angina or myocardial infarction within the past 6 months
9. Cerebrovascular accident within the past 6 months
10. Severe respiratory disease (FEV1\< 50%)
11. Continuous systemic steroid therapy within 1 month before the study
12. Pregnant or breast-feeding women

Primary outcomes:
measure: 3-year relapse-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Morbidity
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: 3-year overall survival
timeFrame: 3 years
measure: 3-year recurrence pattern
timeFrame: 3 years
measure: Postoperative recovery course
timeFrame: 15 days
measure: Inflammatory response
timeFrame: 7 days
measure: Immune response
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA general hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou PLA General Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing General Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Dieases
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Southwest Hospital, China
name: Peiwu Yu, M.D.
role: STUDY_CHAIR
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