Stomach NeoplasmNCT03524300
Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
A study testing Robotic Assisted Total Gastrectomy and Laparoscopic Assisted Total Gastrectomy in people with Stomach Neoplasm and Robotic Surgery, run by Fujian Medical University at 1 site in China.
Trial summary
The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasm, Robotic Surgery
- What is being tested?
- Robotic Assisted Total Gastrectomy and Laparoscopic Assisted Total Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Nov 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall results.
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Who cannot join
- cStage IIA or more advaned at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- Multiple primary cancer
- History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
Show all 16Show fewer
- Gastric multiple primary carcinoma
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Changming Huang, Professor, 8613805069676, hcmlr2002@163.com
Ruhong Tu, M.D, 8615980278081, 794561137@qq.com
About this study
Official title: Prospective Randomized Controlled Trial for Comparison of Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer
Read the detailed description
Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted total gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic assisted total gastrectomy in the treatment of clinical Stage I gastric adenocarcinoma （cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0））.
- Conditions
- Stomach Neoplasm, Robotic Surgery
- Being tested
- Robotic Assisted Total Gastrectomy, Laparoscopic Assisted Total Gastrectomy
- Keywords
- Stomach Neoplasm, Robotic Surgery, 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 Assisted Total GastrectomyProcedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total gastrectomy will be performed in the experimental group.
Laparoscopic Assisted Total GastrectomyProcedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Assisted Total Gastrectomy | Experimental | Robotic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group. Receives: Procedure: Robotic Assisted Total Gastrectomy |
| Laparoscopic Assisted Total Gastrectomy | Active comparator | Laparoscopic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group. Receives: Procedure: Laparoscopic Assisted Total Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
the rate of 3-year disease free survival
Measured: 36 months
Secondary outcomes (14)
3-year overall survival rate
the rate of 3-year overall survival rate
Measured: 36 months
3-year recurrence pattern
the pattern of recurrence in 3 years
Measured: 36 months
overall postoperative morbidity rates
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Measured: 30 days
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
Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Measured: 30 days
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Measured: 30 days
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course
Measured: 30 days
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Measured: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Measured: 30 days
The variation of weight
The variation of weight in kilograms on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Measured: 3, 6, 9 and 12 months
The variation of white blood cell count
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
Hospitalization expenses
The cost from admission to discharge
Measured: 30 days
operation time
operation time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Jun 2018
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Changming Huang, Professor, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524300
- Sponsor's protocol ID
- FUGES-015
- Status last verified
- Feb 2020
- First submitted
- 2 May 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial for Comparison of Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
- ClinicalTrials.gov ID
- NCT03524300
- Acronym / sponsor ID
- FUGES-015
- Conditions
- Stomach Neoplasm, Robotic Surgery
- Keywords
- Stomach Neoplasm, Robotic Surgery, Total Gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 14 May 2018 (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.
The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer
Detailed description
Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted total gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic assisted total gastrectomy in the treatment of clinical Stage I gastric adenocarcinoma （cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0））.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted Total Gastrectomy | Experimental | Procedure: Robotic Assisted Total GastrectomyRobotic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group. |
| Laparoscopic Assisted Total Gastrectomy | Active comparator | Procedure: Laparoscopic Assisted Total GastrectomyLaparoscopic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall results.
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
Key exclusion criteria (16 listed)
- cStage IIA or more advaned at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- Multiple primary 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 Assisted Total GastrectomyAfter exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total gastrectomy will be performed in the experimental group. | Procedure or surgery | Robotic Assisted Total Gastrectomy |
| Laparoscopic Assisted Total GastrectomyAfter exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental group. | Procedure or surgery | Laparoscopic Assisted Total Gastrectomy |
Primary outcome
3-year disease free survival rate
Time frame: 36 months
the rate of 3-year disease free survival
14 secondary outcomes
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
overall postoperative morbidity rates
Time frame: 30 days
intraoperative morbidity rates
Time frame: 1 day
overall postoperative serious morbidity rates
Time frame: 30 days
Time to first ambulation
Time frame: 30 days
Time to first flatus
Time frame: 30 days
Time to first liquid diet
Time frame: 30 days
Time to first soft diet
Time frame: 30 days
Duration of postoperative hospital stay
Time frame: 30 days
The variation of weight
Time frame: 3, 6, 9 and 12 months
The variation of white blood cell count
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
Hospitalization expenses
Time frame: 30 days
operation time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Changming Huang, Professor principal investigator
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 Assisted Total Gastrectomy and Laparoscopic Assisted Total Gastrectomy in people with Stomach Neoplasm and Robotic Surgery, 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 6 inclusion and 16 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 5 Feb 2020. 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 Changming Huang, Professor (+86-138-0506-9676, 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 5 Feb 2020.