Stomach NeoplasmsNCT03006263
Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer
A study testing Totally Laparoscopic Total Gastrectomy and Laparoscopy Assisted Total Gastrectomy in people with Stomach Neoplasms, run by Fujian Medical University.
Trial summary
The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Totally Laparoscopic Total Gastrectomy and Laparoscopy Assisted Total Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 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 between 18 to 75 years old
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- 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
- Pregnant and lactating women
- Suffering from severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
- History of other malignant disease within the past 5 years
Show all 13Show fewer
- 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
About this study
The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.
- Conditions
- Stomach Neoplasms
- Being tested
- Totally Laparoscopic Total Gastrectomy, Laparoscopy Assisted Total Gastrectomy
- Keywords
- Stomach Neoplasms, Totally Laparoscopic Total Gastrectomy, Laparoscopy Assisted 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.
Totally Laparoscopic Total GastrectomyProcedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
Laparoscopy Assisted Total GastrectomyProcedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
| Study group | Role | What they receive |
|---|---|---|
| Totally Laparoscopic Total Gastrectomy | Experimental | Totally Laparoscopic Total Gastrectomy will be performed for the treatment of patients assigned to this group. Receives: Procedure: Totally Laparoscopic Total Gastrectomy |
| Laparoscopy Assisted Total Gastrectomy | Experimental | Laparoscopy Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group. Receives: Procedure: Laparoscopy Assisted Total Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (17)
3-year overall survival rate
Measured: 36 months
3-year disease free 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
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
Postoperative pain
Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.
Measured: 30 days
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Measured: 3, 6, 9 and 12 months
The variation of cholesterol
The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Measured: 3, 6, 9 and 12 months
The results of endoscopy
The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
Measured: 3 and 12 months
The variation of body temperature
The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
Measured: 8 days
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 and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
The values of hemoglobin in gram/liter 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
The variation of C-reactive protein
The values of C-reactive protein IN milligram/liter 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 posted30 Dec 2016 (estimated)
- Study start1 Nov 2016
- Primary completionNov 2021 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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
- 110 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,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006263
- Sponsor's protocol ID
- 2016YF021-02
- Status last verified
- Feb 2020
- First submitted
- 26 Dec 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
- Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT03006263
- Acronym / sponsor ID
- 2016YF021-02
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, Totally Laparoscopic Total Gastrectomy, Laparoscopy Assisted Total Gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 30 Dec 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.
The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Totally Laparoscopic Total Gastrectomy | Experimental | Procedure: Totally Laparoscopic Total GastrectomyTotally Laparoscopic Total Gastrectomy will be performed for the treatment of patients assigned to this group. |
| Laparoscopy Assisted Total Gastrectomy | Experimental | Procedure: Laparoscopy Assisted Total GastrectomyLaparoscopy 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 (7 listed)
- Age between 18 to 75 years old
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
Key exclusion criteria (13 listed)
- Pregnant and lactating women
- Suffering from severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
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 |
|---|---|---|
| Totally Laparoscopic Total GastrectomyAfter exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience. | Procedure or surgery | Totally Laparoscopic Total Gastrectomy |
| Laparoscopy Assisted Total GastrectomyAfter exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience. | Procedure or surgery | Laparoscopy Assisted Total Gastrectomy |
Primary outcome
overall postoperative morbidity rates
Time frame: 30 days
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
17 secondary outcomes
3-year overall survival rate
Time frame: 36 months
3-year disease free survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Intraoperative morbidity rates
Time frame: 1 day
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
Postoperative pain
Time frame: 30 days
The variation of weight
Time frame: 3, 6, 9 and 12 months
The variation of cholesterol
Time frame: 3, 6, 9 and 12 months
The results of endoscopy
Time frame: 3 and 12 months
The variation of body temperature
Time frame: 8 days
The variation of white blood cell count
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
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: No
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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,China
Questions about this trial
What is this clinical trial studying?
A study testing Totally Laparoscopic Total Gastrectomy and Laparoscopy Assisted Total Gastrectomy in people with Stomach Neoplasms, run by Fujian Medical University.
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 7 inclusion and 13 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall postoperative morbidity rates (time frame: 30 days). 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.