Gastric CancerNCT02806661
Comparison of Vagus Nerve-preserving RADG and Conventional RADG for AGC
A study testing Vagus nerve-preserving Robot-assisted Gastrectomy and Conventional Robot-assisted Gastrectomy in people with Gastric Cancer, run by Yingxue Hao at 1 site in China.
Trial summary
Through comparative observation of robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve) operative and postoperative indicators, and evaluating the feasibility and safety of vagus nerve preserving distal gastric cancer… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Vagus nerve-preserving Robot-assisted Gastrectomy and Conventional Robot-assisted Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged less than 70 years and more than 18 years;
- Underwent gastroscopy and biopsy - preoperative definite for advanced gastric cancer invasion depth is T2, T3;
- The lesion is in the middle and lower stomach;
- Magix routine upper gastrointestinal barium meal, endoscopic ultrasonography, abdominal CT and chest X ray examination, clearly no nerve invasion and adjacent organ invasion and distant metastasis;
- The preoperative examination of lung, liver, heart, renal insufficiency, surgical contraindication;
- The preoperative abdominal CT or abdominal ultrasound without biliary disease and gallbladder stones;
- No history of gastrointestinal dysfunction and other malignant tumor history;
- The patients voluntarily participate in the study and signed informed consent.
Who cannot join
- Older than 70 years old or because of chemotherapy surgery and complications after intolerance;
- The vagus nerve invasion or invasion of adjacent organs or confirmed the presence of distant metastasis;
- Have a history of abdominal surgery or chemotherapy before surgery;
- The recent cardiovascular hemorrhagic or ischemic disease;
- The amount of abnormal glucose tolerance or diabetes;
- Not suitable for robotic surgery, such as body short that mechanical arm can not have enough activity range;
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- The history of biliary calculi or gastrointestinal dysfunction;
- The other is not suitable for receiving robot surgery;
- Participated in other clinical studies in the last month;
- Other researchers not suitable for participation in the study of (HIV infection and intravenous drug addict), or other effects of this clinical study results analysis of the situation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Vagus Nerve-preserving Robot-assisted Distal Gastrectomy (RADG) and Conventional Robot-assisted Distal Gastrectomy for Advanced Gastric Cancer (AGC)
Through comparative observation of robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve) operative and postoperative indicators, and evaluating the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.
Read the detailed description
Compare the robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve). Observe the operative and postoperative indicators, and evaluate the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.
- Conditions
- Gastric Cancer
- Being tested
- Vagus nerve-preserving Robot-assisted Gastrectomy, Conventional Robot-assisted Gastrectomy
- Keywords
- Robotic surgery, Vagus nerve preserving
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve-preserving Robot-assisted GastrectomyProcedure or surgery
Conventional Robot-assisted GastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| VPRDG for AGC | Experimental | Vagus nerve-preserving Robot-assisted distal subtotal gastrectomy (VPRDG) with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group. Receives: Procedure: Vagus nerve-preserving Robot-assisted Gastrectomy |
| CRDG FOR AGC | Active comparator | Conventional Robot-assisted distal subtotal gastrectomy (CRDG) with D2 lymphadenectomy without preserving vagus nerve will be performed for the treatment of patients assigned to this group. Receives: Procedure: Conventional Robot-assisted Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Recurrence rate in 3 years after operating.
Measured: up to 36 months
Secondary outcomes (4)
3-years survival rate
Survival rate in 3 years after operating.
Measured: up to 36 months
The rate of Calculus of gallbladder
The rate of gallbladder calculus in 1 year after operating, which is diagnosed by ultrasound.
Measured: up to 12 months
Number of retrieving lymph nodes
The number of dissecting lymph nodes during operating.
Measured: up to 1 week
Inflammatory factors
Detecting Interleukin -10 (IL-10), C-reactive protein (CRP) and Tumor Necrosis Factor (TNF-a) in 6 h, 12 h, 24 h, and 72h after operating.
Measured: 6 h, 12 h, 24 h, and 72h after operating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yingxue Hao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yingxue Hao, Southwest Hospital, China
- Investigators
- Yingxue Hao, M.D., Principal investigator, Southwest Hospital, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806661
- Sponsor's protocol ID
- RADG160416
- Status last verified
- Jun 2016
- First submitted
- 16 Apr 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Yes, the investigators can share the data with other.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vagus Nerve-preserving Robot-assisted Distal Gastrectomy (RADG) and Conventional Robot-assisted Distal Gastrectomy for Advanced Gastric Cancer (AGC)
- ClinicalTrials.gov ID
- NCT02806661
- Acronym / sponsor ID
- RADG160416
- Conditions
- Gastric Cancer
- Keywords
- Robotic surgery, Vagus nerve preserving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yingxue HaoUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- 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.
Through comparative observation of robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve) operative and postoperative indicators, and evaluating the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.
Detailed description
Compare the robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve). Observe the operative and postoperative indicators, and evaluate the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VPRDG for AGC | Experimental | Procedure: Vagus nerve-preserving Robot-assisted GastrectomyVagus nerve-preserving Robot-assisted distal subtotal gastrectomy (VPRDG) with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group. |
| CRDG FOR AGC | Active comparator | Procedure: Conventional Robot-assisted GastrectomyConventional Robot-assisted distal subtotal gastrectomy (CRDG) with D2 lymphadenectomy without preserving vagus nerve will be performed for the treatment of patients assigned to this group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, aged less than 70 years and more than 18 years;
- Underwent gastroscopy and biopsy - preoperative definite for advanced gastric cancer invasion depth is T2, T3;
- The lesion is in the middle and lower stomach;
- Magix routine upper gastrointestinal barium meal, endoscopic ultrasonography, abdominal CT and chest X ray examination, clearly no nerve invasion and adjacent organ invasion and distant metastasis;
- The preoperative examination of lung, liver, heart, renal insufficiency, surgical contraindication;
Key exclusion criteria (10 listed)
- Older than 70 years old or because of chemotherapy surgery and complications after intolerance;
- The vagus nerve invasion or invasion of adjacent organs or confirmed the presence of distant metastasis;
- Have a history of abdominal surgery or chemotherapy before surgery;
- The recent cardiovascular hemorrhagic or ischemic disease;
- The amount of abnormal glucose tolerance or diabetes;
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 |
|---|---|---|
| Vagus nerve-preserving Robot-assisted Gastrectomy | Procedure or surgery | VPRDG for AGC |
| Conventional Robot-assisted Gastrectomy | Procedure or surgery | CRDG FOR AGC |
Primary outcome
Recurrence rate
Time frame: up to 36 months
Recurrence rate in 3 years after operating.
4 secondary outcomes
3-years survival rate
Time frame: up to 36 months
The rate of Calculus of gallbladder
Time frame: up to 12 months
Number of retrieving lymph nodes
Time frame: up to 1 week
Inflammatory factors
Time frame: 6 h, 12 h, 24 h, and 72h after operating
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Individual participant dataSharing planned: Yes. Yes, the investigators can share the data with other.
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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. This study is not recruiting at the moment.
Yingxue Hao, M.D. principal investigator
Southwest Hospital, Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve-preserving Robot-assisted Gastrectomy and Conventional Robot-assisted Gastrectomy in people with Gastric Cancer, run by Yingxue Hao 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingxue Hao, M.D. (086-2368754167, haoyingxue@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: up to 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 20 Jun 2016.