Gastric CancerNCT05235932
the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
A study testing Robotic radical total gastrectomy with D2 lymphadenectomy and Laparoscopic radical total gastrectomy with D2 lymphadenectomy in people with Gastric Cancer and Robotic Gastrectomy, run by Fujian Medical University at 1 site in China.
Trial summary
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Robotic Gastrectomy
- What is being tested?
- Robotic radical total gastrectomy with D2 lymphadenectomy and Laparoscopic radical total gastrectomy with D2 lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2022to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.
- 3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.
- 5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent
Who cannot join
- Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy(except for ESD/EMR for gastric cancer )
- Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
Show all 14Show fewer
- History of other malignant disease within the past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1 (forced expiratory volume in one second)<50% of predicted values
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .
Read the 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 robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.
- Conditions
- Gastric Cancer, Robotic Gastrectomy
- Being tested
- Robotic radical total gastrectomy with D2 lymphadenectomy, Laparoscopic radical total gastrectomy with D2 lymphadenectomy
- Keywords
- robotic radical total gastrectomy, Gastric Cancer, laparoscopic radical total gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic radical total gastrectomy with D2 lymphadenectomyProcedure or surgery
Most surgical procedures are performed using the robot system.
Laparoscopic radical total gastrectomy with D2 lymphadenectomyProcedure or surgery
Without the robot system, Most surgical procedures are performed using laparoscopic equipment.
| Study group | Role | What they receive |
|---|---|---|
| Robotic radical total gastrectomy with D2 lymphadenectomy | Experimental | After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy Receives: Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy |
| Laparoscopic radical total gastrectomy with D2 lymphadenectomy | Active comparator | After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy Receives: Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
3-year disease free survival rate
Measured: 36 months
Secondary outcomes (9)
Morbidity rates
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
Measured: 30 days
3-year overall survival rate
3-year overall survival rate
Measured: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Measured: 36 months
intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Measured: 1 day
overall postoperative serious morbidity rates
Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
Measured: 30 days
Total Number of Retrieved Lymph Nodes
Total Number of Retrieved Lymph Nodes
Measured: 1 day
postoperative recovery course
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Measured: 30 days
postoperative nutritional status
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Measured: 3, 6, 9 and 12 months
inflammatory immune response
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
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Tianjin Medical University Cancer Institute and Hospital, The First Affiliated Hospital of Nanchang University, Lanzhou Military Region General Hospital, Gansu Provincial Hospital, Southwest Hospital, China, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, Second Xiangya Hospital of Central South University, Hebei Medical University Fourth Hospital, The Affiliated Hospital of Qingdao University, The Second Affiliated Hospital of Dalian Medical University
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University Union Hospital
- Investigators
- Chang-ming Huang, MD, Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235932
- Sponsor's protocol ID
- 2022-02
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
- ClinicalTrials.gov ID
- NCT05235932
- Acronym / sponsor ID
- 2022-02
- Conditions
- Gastric Cancer, Robotic Gastrectomy
- Keywords
- robotic radical total gastrectomy, Gastric Cancer, laparoscopic radical total gastrectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Tianjin Medical University Cancer Institute and Hospital, The First Affiliated Hospital of Nanchang University, Lanzhou Military Region General Hospital, Gansu Provincial Hospital, Southwest Hospital, China, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, Second Xiangya Hospital of Central South University, Hebei Medical University Fourth Hospital, The Affiliated Hospital of Qingdao University, The Second Affiliated Hospital of Dalian Medical University
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, 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 robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic radical total gastrectomy with D2 lymphadenectomy | Experimental | Procedure: Robotic radical total gastrectomy with D2 lymphadenectomyAfter exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy |
| Laparoscopic radical total gastrectomy with D2 lymphadenectomy | Active comparator | Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomyAfter exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.
- 3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.
- 5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent
Key exclusion criteria (14 listed)
- Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy(except for ESD/EMR for gastric cancer )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic radical total gastrectomy with D2 lymphadenectomyMost surgical procedures are performed using the robot system. | Procedure or surgery | Robotic radical total gastrectomy with D2 lymphadenectomy |
| Laparoscopic radical total gastrectomy with D2 lymphadenectomyWithout the robot system, Most surgical procedures are performed using laparoscopic equipment. | Procedure or surgery | Laparoscopic radical total gastrectomy with D2 lymphadenectomy |
Primary outcome
3-year disease free survival rate
Time frame: 36 months
3-year disease free survival rate
9 secondary outcomes
Morbidity rates
Time frame: 30 days
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
intraoperative morbidity rates
Time frame: 1 day
overall postoperative serious morbidity rates
Time frame: 30 days
Total Number of Retrieved Lymph Nodes
Time frame: 1 day
postoperative recovery course
Time frame: 30 days
postoperative nutritional status
Time frame: 3, 6, 9 and 12 months
inflammatory immune response
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chang-ming Huang, MD study chair
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic radical total gastrectomy with D2 lymphadenectomy and Laparoscopic radical total gastrectomy with D2 lymphadenectomy in people with Gastric Cancer and Robotic Gastrectomy, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang-ming Huang, MD (+86-13805069676, hcmlr2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.