Gastric CancerPhase 3NCT02980861
Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection
A Phase 3 study testing Laparoscopic total gastrectomy and Open total gastrectomy in people with Gastric Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Laparoscopic 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
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jun 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 American Joint Committee On Cancer (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.
Hongqing Xi, Master contact
China1 site
Chinese PLA General Hospital
Beijing, 100853
Lin Chen, Master, 86-13801290395, chenlinbj@sina.com
About this study
Official title: Laparoscopic Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.
Read the detailed description
Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 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 total gastrectomy (LTG) 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. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare the early results of this procedure with open total gastrectomy (OTG).
- Conditions
- Gastric Cancer
- Being tested
- Laparoscopic total gastrectomy, Open total gastrectomy
- Keywords
- Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, 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 total gastrectomyProcedure or surgery
Also called LTG
When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.
Open total gastrectomyProcedure or surgery
Also called OTG
When the participants 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 total gastrectomy | Experimental | Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection. Receives: Procedure: Laparoscopic total gastrectomy |
| Open total gastrectomy | Active comparator | Participants 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.
Number of group Splenic Hilum (No.10) lymph nodes harvested
Measured: 7 days
Secondary outcomes (9)
Early complication rate
The early complication rate is defined as the event observed during operation
Measured: 30 days
Operative time
Measured: Intraoperative
Operative blood loss
Measured: Intraoperative
Time of splenic hilum lymph nodes dissection
Measured: Intraoperative
Number of total lymph nodes harvested
Measured: 7 days
Post-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
3-year overall survival rate
Measured: 3 years
Quality of life
It will be assessed by questionnaire (WHO quality of life-100)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- 200 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
- NCT02980861
- Sponsor's protocol ID
- Z161100000516237
- Status last verified
- Dec 2016
- First submitted
- 30 Nov 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.
PubMed 26940944Guo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31.
PubMed 30380145
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02980861
- Acronym / sponsor ID
- Z161100000516237
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 2 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.
Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.
Detailed description
Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 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 total gastrectomy (LTG) 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. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare 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 total gastrectomy | Experimental | Procedure: Laparoscopic total gastrectomyParticipants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection. |
| Open total gastrectomy | Active comparator | Procedure: Open total gastrectomyParticipants 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 (5 listed)
- Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
- cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (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 |
|---|---|---|
| Laparoscopic total gastrectomyAlso: LTGWhen the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection. | Procedure or surgery | Laparoscopic total gastrectomy |
| Open total gastrectomyAlso: OTGWhen the participants 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
Number of group Splenic Hilum (No.10) 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
Post-operative recovery course
Time frame: 30 days
3-year disease free survival rate
Time frame: 3 years
3-year overall survival rate
Time frame: 3 years
Quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Background: PubMed 26940944Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.
- Derived from this study: PubMed 30380145Guo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31.
- 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.
Hongqing Xi, Master contact
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 Laparoscopic total gastrectomy and Open total gastrectomy in people with Gastric Cancer, 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 6 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 (010-66938128), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of group Splenic Hilum (No.10) 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?
On the ClinicalTrials.gov record for NCT02980861, which also lists 2 linked publications.
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 6 Dec 2016.