Splenic Hilum Lymph Nodes DissectionPhase 3NCT02984787
3D Versus 2D Laparoscopic Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection
A Phase 3 study testing 3D Laparoscopic total gastrectomy and 2D Laparoscopic total gastrectomy in people with Splenic Hilum Lymph Nodes Dissection, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The investigators will perform a prospective randomized comparison between 3D and 2D laparoscopic total gastrectomy with splenic hilum lymph nodes dissection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Splenic Hilum Lymph Nodes Dissection
- What is being tested?
- 3D Laparoscopic total gastrectomy and 2D Laparoscopic total gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jan 2020
- Phase
- Phase 3
- 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
- Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
- cT2-4aN0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition.
- Eastern Cooperative Oncology Group (ECOG): 0 or 1;
- American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
- Written informed consent.
Who cannot join
- Pregnant or breast-feeding women;
- Severe mental disorder;
- Previous upper abdominal surgery (except laparoscopic cholecystectomy);
- Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
- Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
- Other malignant disease within the past 5 years;
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- Previous neoadjuvant chemotherapy or radiotherapy;
- Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
- Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese PLA General Hospital
Beijing, 100853
Lin Chen, 86-13801290395, chenlinbj@sina.com
About this study
Official title: 3D Versus 2D Laparoscopic Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
The investigators will perform a prospective randomized comparison between 3D and 2D laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.
Read the detailed description
A prospective randomized comparison of 3D and 2D laparoscopic surgery for advanced gastric cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to evaluate the safety and feasibility for the extensive application of the novel 3D laparoscopic technique. The evaluation parameters are number of group No.10 lymph nodes harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival and recurrence rates.
- Conditions
- Splenic Hilum Lymph Nodes Dissection
- Being tested
- 3D Laparoscopic total gastrectomy, 2D Laparoscopic total gastrectomy
- Keywords
- Gastric Cancer, 3D, 2D
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Laparoscopic total gastrectomyProcedure or surgery
Also called 3D-LTG
When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection
2D Laparoscopic total gastrectomyProcedure or surgery
Also called 2D-LTG
When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection
| Study group | Role | What they receive |
|---|---|---|
| 3D Laparoscopic total gastrectomy | Experimental | Participants including in the 3D laparoscopic total gastrectomy (3D-LTG) group will undergo 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection. Receives: Procedure: 3D Laparoscopic total gastrectomy |
| 2D Laparoscopic total gastrectomy | Active comparator | Participants including in the 2D laparoscopic total gastrectomy (2D-LTG) group will undergo 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection. Receives: Procedure: 2D Laparoscopic total gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of splenic hilum lymph nodes harvested
Measured: 7 days
Secondary outcomes (9)
Early complication rate
The early complication rate is defined as the event observed during operation and within 30 days after surgery.
Measured: 30 days
Operative time
It will be assessed with the unit of "minute".
Measured: Intraoperative
Operative blood loss
It will be assessed with the unit of "ml".
Measured: Intraoperative
Time of splenic hilum lymph nodes dissection
It will be assessed with the unit of "minute"
Measured: Intraoperative
Number of total lymph nodes harvested
Measured: 7 days
Poster-operative recovery course
Time to first ambulation (unit of hour), flatus (unit of hour), liquid diet (unit of hour) and duration of hospital stay (unit of day) are used to assess the postoperative recovery course.
Measured: 30 days
Quality of life
It will be assessed with questionnaire of "WHO-QOL-100" (WHO was short for world health organization)
Measured: 1 year
3-year disease free survival rate
Measured: 3 years
3-year overall survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenic Hilum Lymph Nodes DissectionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, Chinese PLA General Hospital
- Investigators
- Lin Chen, Principal investigator, the Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984787
- Sponsor's protocol ID
- Experiment20161201
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 7 Dec 2016
- 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 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Versus 2D Laparoscopic Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02984787
- Acronym / sponsor ID
- Experiment20161201
- Conditions
- Splenic Hilum Lymph Nodes Dissection
- Keywords
- Gastric Cancer, 3D, 2D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 7 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 investigators will perform a prospective randomized comparison between 3D and 2D laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.
Detailed description
A prospective randomized comparison of 3D and 2D laparoscopic surgery for advanced gastric cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to evaluate the safety and feasibility for the extensive application of the novel 3D laparoscopic technique. The evaluation parameters are number of group No.10 lymph nodes harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival and recurrence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Laparoscopic total gastrectomy | Experimental | Procedure: 3D Laparoscopic total gastrectomyParticipants including in the 3D laparoscopic total gastrectomy (3D-LTG) group will undergo 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection. |
| 2D Laparoscopic total gastrectomy | Active comparator | Procedure: 2D Laparoscopic total gastrectomyParticipants including in the 2D laparoscopic total gastrectomy (2D-LTG) group will undergo 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
- cT2-4aN0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition.
- Eastern Cooperative Oncology Group (ECOG): 0 or 1;
- American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
- Written informed consent.
Key exclusion criteria (9 listed)
- Pregnant or breast-feeding women;
- Severe mental disorder;
- Previous upper abdominal surgery (except laparoscopic cholecystectomy);
- Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
- Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
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 |
|---|---|---|
| 3D Laparoscopic total gastrectomyAlso: 3D-LTGWhen participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection | Procedure or surgery | 3D Laparoscopic total gastrectomy |
| 2D Laparoscopic total gastrectomyAlso: 2D-LTGWhen participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection | Procedure or surgery | 2D Laparoscopic total gastrectomy |
Primary outcome
Number of splenic hilum lymph nodes harvested
Time frame: 7 days
9 secondary outcomes
Early complication rate
Time frame: 30 days
Operative time
Time frame: Intraoperative
Operative blood loss
Time frame: Intraoperative
Time of splenic hilum lymph nodes dissection
Time frame: Intraoperative
Number of total lymph nodes harvested
Time frame: 7 days
Poster-operative recovery course
Time frame: 30 days
Quality of life
Time frame: 1 year
3-year disease free survival rate
Time frame: 3 years
3-year overall survival rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Individual participant dataSharing planned: No
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.
Lin Chen principal investigator
the Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3D Laparoscopic total gastrectomy and 2D Laparoscopic total gastrectomy in people with Splenic Hilum Lymph Nodes Dissection, run by Chinese PLA General Hospital 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 5 inclusion and 9 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 7 Dec 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hongqing Xi, Master (86-13801290395, chenlinbj@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of splenic hilum lymph nodes harvested (time frame: 7 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 7 Dec 2016.