Gastric CancerPhase 2NCT02711033
Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection
A Phase 2 study testing Laparoscopic-assisted total gastrectomy and Open total gastrectomy in people with Gastric Cancer and Splenic Hilum Lymph Nodes Dissection, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Total Gastrectomy
- What is being tested?
- Laparoscopic-assisted total gastrectomy and Open total gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Apr 2019
- Phase
- Phase 2
- 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
- Patient with advanced proximal gastric cancer （T2-T4a,N0-N3,M0）
- Informed consent
- Eastern Cooperative Oncology Group (ECOG): 0 ot 1
- American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ
Who cannot join
- Pregnancy or female in suckling period
- Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- Severe mental disease
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
- Body mass index (BMI) > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510120
Wei Wang, M.D.,PH.D., +86-13922255515, wangwei16400@163.com
Wenjun Xiong, M.D., +86-15920553177, xiongwj1988@163.com
About this study
Official title: Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.
Read the detailed description
For advanced proximal gastric cancer, total gastrectomy with D2 lymphadenectomy is the standard surgical therapy. Apparently, lymph nodes (LNs) dissection along the splenic artery (No.11) and the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines. Nevertheless, complete removal of the No. 10 and No. 11d LNs is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic-assisted total gastrectomy (LATG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Herein, we aim to investigate the safety and feasibility of LATG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy (OTG).
- Being tested
- Laparoscopic-assisted total gastrectomy, Open 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.
Laparoscopic-assisted total gastrectomyProcedure or surgery
Also called LATG
When patients with advanced proximal gastric cancer are randomized in the laparoscopic-assisted total gastrectomy (LATG) group, they will received LATG with spleen-preserving splenic hilum lymph nodes dissection.
Open total gastrectomyProcedure or surgery
Also called OTG
When patients with advanced proximal gastric cancer are randomized in the open total gastrectomy (OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic-assisted total gastrectomy | Experimental | Patients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection. Receives: Procedure: Laparoscopic-assisted total gastrectomy |
| Open total gastrectomy | Active comparator | Patients who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection. Receives: Procedure: Open total gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early complication rate
The early complication rate is defined as the event observed during operation and within 30 days after surgery.
Measured: 30 days
Secondary outcomes (11)
Operative time
Measured: Intraoperative
Time of splenic hilum lymph nodes dissection
Measured: Intraoperative
Operative blood loss
It will be assessed with the unit of "ml".
Measured: Intraoperative
Incision length
Measured: 7 days
Number of total lymph nodes harvested
Measured: 7 days
Number of group No.10 lymph nodes harvested
Measured: 7 days
Number of lymph nodes posterior to splenic vessel
Measured: 7 days
Poster-operative recovery course
Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course.
Measured: 30 days
3-year disease free survival rate
Measured: 3 years
5-year overall survival rate
Measured: 5 years
Metastasis rate of lymph nodes posterior to splenic vessel
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2018 (estimated)
- Study completionApr 2019 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Wei Wang, M.D., PH.D., Principal investigator, Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711033
- Sponsor's protocol ID
- GDPHCM-GI-01
- Status last verified
- Apr 2017
- First submitted
- 9 Mar 2016
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02711033
- Acronym / sponsor ID
- GDPHCM-GI-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 17 Mar 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.
This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.
Detailed description
For advanced proximal gastric cancer, total gastrectomy with D2 lymphadenectomy is the standard surgical therapy. Apparently, lymph nodes (LNs) dissection along the splenic artery (No.11) and the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines. Nevertheless, complete removal of the No. 10 and No. 11d LNs is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic-assisted total gastrectomy (LATG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Herein, we aim to investigate the safety and feasibility of LATG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy (OTG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic-assisted total gastrectomy | Experimental | Procedure: Laparoscopic-assisted total gastrectomyPatients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection. |
| Open total gastrectomy | Active comparator | Procedure: Open total gastrectomyPatients who are included in the open total gastrectomy (OTG) group will OTG 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 (4 listed)
- Patient with advanced proximal gastric cancer （T2-T4a,N0-N3,M0）
- Informed consent
- Eastern Cooperative Oncology Group (ECOG): 0 ot 1
- American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ
Key exclusion criteria (5 listed)
- Pregnancy or female in suckling period
- Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- Severe mental disease
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
- Body mass index (BMI) > 30 kg/m2
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 |
|---|---|---|
| Laparoscopic-assisted total gastrectomyAlso: LATGWhen patients with advanced proximal gastric cancer are randomized in the laparoscopic-assisted total gastrectomy (LATG) group, they will received LATG with spleen-preserving splenic hilum lymph nodes dissection. | Procedure or surgery | Laparoscopic-assisted total gastrectomy |
| Open total gastrectomyAlso: OTGWhen patients with advanced proximal gastric cancer are randomized in the open total gastrectomy (OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection. | Procedure or surgery | Open total gastrectomy |
Primary outcome
Early complication rate
Time frame: 30 days
The early complication rate is defined as the event observed during operation and within 30 days after surgery.
11 secondary outcomes
Operative time
Time frame: Intraoperative
Time of splenic hilum lymph nodes dissection
Time frame: Intraoperative
Operative blood loss
Time frame: Intraoperative
Incision length
Time frame: 7 days
Number of total lymph nodes harvested
Time frame: 7 days
Number of group No.10 lymph nodes harvested
Time frame: 7 days
Number of lymph nodes posterior to splenic vessel
Time frame: 7 days
Poster-operative recovery course
Time frame: 30 days
3-year disease free survival rate
Time frame: 3 years
5-year overall survival rate
Time frame: 5 years
Metastasis rate of lymph nodes posterior to splenic vessel
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- 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.
Wei Wang, M.D., PH.D. principal investigator
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopic-assisted total gastrectomy and Open total gastrectomy in people with Gastric Cancer and Splenic Hilum Lymph Nodes Dissection, run by Guangdong Provincial Hospital of Traditional Chinese Medicine 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 4 inclusion and 5 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 10 Apr 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wei Wang, M.D., PH.D. (+86-13922255515, wangwei16400@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early complication rate (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 10 Apr 2017.