Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer

September 5, 2017 updated by: Yan Shi, Southwest Hospital, China

Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer: a Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing, China
        • Peking University Cancer Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • Lanzhou PLA General Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen University Cancer Center
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Union Hospital, Tongji Medical college, Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital Of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing General Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China
        • Jilin Cancer Hospital
    • Shandong
      • Qingdao, Shandong, China
        • The Affiliated Hospital of Qingdao University
    • Shanxi
      • Xi'an, Shanxi, China
        • Xijing Hospital of Digestive Dieases
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic gastrectomy
Robotic distal gastrectomy with D2 nodal dissection
Procedure: Robotic distal gastrectomy with D2 nodal dissection
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, robotic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
Active Comparator: Laparoscopic gastrectomy
Laparoscopic distal gastrectomy with D2 nodal dissection
Procedure: Laparoscopic distal gastrectomy with D2 nodal dissection
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year relapse-free survival
Time Frame: 3 years
Relapse-free survival is defined as days from surgery to recurrence or death from any cause, and it is censored at the latest day when the patient is alive without any evidence of recurrence.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 30 days
Early postoperative morbidity confined to events that occur within 30 days after surgery. The complications that occur after postoperative day 30 belong to late postoperative morbidity
30 days
Mortality
Time Frame: 30 days
Postoperative mortality is defined to death that occurs within 30 days.
30 days
3-year overall survival
Time Frame: 3 years
Overall survival is defined as days from surgery to death from any cause, and it is censored at the last day when the patient was alive.
3 years
3-year recurrence pattern
Time Frame: 3 years
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
3 years
Postoperative recovery course
Time Frame: 15 days
Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recovery course.
15 days
Inflammatory response
Time Frame: 7 days
The daily highest body temperature before discharge and the values of white blood cell count (10^9/L), hemoglobin (g/L), C-reactive protein (mg/L) and prealbumin (mg/L) from peripheral blood before operation and on postoperative day 1, 3, 5, 7 are recorded.
7 days
Immune response
Time Frame: 7 days
The values of relevant immune cytokines from peripheral blood before operation and on postoperative day 1, 3, 5, 7 are recorded.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Hospital, China

Collaborators

The First Affiliated Hospital of Nanchang University
Sun Yat-sen University
Chinese PLA General Hospital
West China Hospital
Peking University Cancer Hospital & Institute
Jilin Provincial Tumor Hospital
Qingdao University
Xijing Hospital of Digestive Diseases
Wuhan Union Hospital, China
Fujian Medical University Union Hospital
Central South University
Nanjing PLA General Hospital
Lanzhou General Hospital of PLA

Investigators

  • Study Chair: Peiwu Yu, M.D., Southwest Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 25, 2017

Primary Completion (Anticipated)

September 25, 2019

Study Completion (Anticipated)

September 25, 2022

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

September 2, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 8, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRASS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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