Stomach NeoplasmsLSPLNNCT02333721
Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
A study testing D2 lymphadenectomy including No. 10 and D2 lymphadenectomy excluding No. 10 in people with Stomach Neoplasms, run by Fujian Medical University at 1 site in China.
Trial summary
The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- D2 lymphadenectomy including No. 10 and D2 lymphadenectomy excluding No. 10
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2021
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age from 18 to 75 years
- Primary proximal gastric adenocarcinoma not invading greater curvature (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
Who cannot join
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
Show all 13Show fewer
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of predicted values
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Changming Huang, M.D., Ph.D., +86-133-6591-0253, hcmlr2002@163.com
Changming Huang, M.D., Ph.D.
About this study
Official title: Study on Long-term Outcome of Laparoscopic Spleen-Preserving D2 Lymphadenectomy With and Without No. 10 Lymph Node Dissection for Advanced Gastric Cancer
The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature.
Read the detailed description
A prospective randomized comparison of laparoscopic spleen-preserving No. 10 lymph node dissection for gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
- Conditions
- Stomach Neoplasms
- Being tested
- D2 lymphadenectomy including No. 10, D2 lymphadenectomy excluding No. 10
- Keywords
- Stomach Neoplasms, Laparoscopy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D2 lymphadenectomy including No. 10Procedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
D2 lymphadenectomy excluding No. 10Procedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
| Study group | Role | What they receive |
|---|---|---|
| D2 Lymphadenectomy including No. 10 | Experimental | Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group Receives: Procedure: D2 lymphadenectomy including No. 10 |
| D2 lymphadenectomy excluding No. 10 | Active comparator | Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group Receives: Procedure: D2 lymphadenectomy excluding No. 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
Measured: 36 months
Secondary outcomes (32)
Morbidity and mortality
The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
Measured: 30 days; 36 months
3-year overall survival rate
3-year overall 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
Time to first ambulation
The data of postoperative recovery course.
Measured: 10 days
Rates of splenectomy
splenectomy performing by severe injury to the splenic vessels
Measured: 1 day
Rates of injury to splenic vessels
intraoperative injury to the splenic vessels
Measured: 1 day
The number of lymph node dissection
The total number of lymph node dissection and the number of lymph node dissection in each station
Measured: 1 day
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months
Measured: 12 months
The daily highest body temperature
The daily highest body temperature before discharge
Measured: 7 days
Time to first flatus
The time to first flatus
Measured: 10 days
Time to first liquid diet
The time to first liquid diet
Measured: 10 days
Time to soft diet
The time to soft diet
Measured: 10 days
Duration of hospital stay
Duration of hospital stay
Measured: 10 days
The amount of abdominal drainage
The amount of abdominal drainage
Measured: 10 days
Blood transfusion
Perioperative blood transfusion
Measured: 10 days
The number of positive lymph nodes
The number of positive lymph nodes
Measured: 1 day
Intraoperative lymph node dissection time
intraoperative No.10 lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node)
Measured: 1 day
Intraoperative blood loss
Intraoperative blood loss
Measured: 1 day
Intraoperative injury
Intraoperative injury
Measured: 1 day
The amount of use of titanium clip
The amount of use of titanium clip
Measured: 1 day
The rate of conversion to laparotomy
The rate of conversion to laparotomy
Measured: 1 day
The variation of cholesterol
The variation of cholesterol on postoperative 3, 6, 9 and 12 months
Measured: 12 months
The variation of albumin
The variation of albumin on postoperative 3, 6, 9 and 12 months
Measured: 12 months
The results of endoscopy
the results of endoscopy on postoperative 3 and 12 months
Measured: 12 months
The values 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.
Measured: 7 days
The values of hemoglobin
and the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
The values of C-reactive protein
and the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
The values of prealbumin
and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
The values of relevant immune cytokines
and the values of relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
The Surgery Task Load Index (SURG-TLX)
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Measured: 1 days
Lymph node noncompliance rate
Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.
Measured: 1 days
Technical performance
Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 536 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 Union Hospital
- Investigators
- Changming Huang, M.D.,Ph.D., Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333721
- Sponsor's protocol ID
- FUGES-002
- Acronym
- LSPLN
- Status last verified
- Sep 2020
- First submitted
- 25 Dec 2014
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhong Q, Zhang ZQ, Yan YQ, Li YF, He QC, Zheng CH, Chen QY, Huang CM. [Long-term oncological safety of robotic total gastrectomy for locally advanced proximal gastric cancer: a 5-year noninferiority comparison based on the FUGES-014 study]. Zhonghua Wei Chang Wai Ke Za Zhi. 2025 Aug 25;28(8):886-894. doi: 10.3760/cma.j.cn441530-20250610-00218. Chinese.
PubMed 40850834Xu BB, Zheng HL, Chen CS, Xu LL, Xue Z, Wei LH, Zheng HH, Shen LL, Zheng CH, Li P, Xie JW, Lin JX, Zheng YH, Huang CM. Development and validation of a preoperative radiomics-based nomogram to identify patients who can benefit from splenic hilar lymphadenectomy: a pooled analysis of three prospective trials. Int J Surg. 2024 Jul 1;110(7):4053-4061. doi: 10.1097/JS9.0000000000001337.
PubMed 38980664Lin JX, Xu BB, Zheng HL, Li P, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Yao ZH, Zheng CH, Huang CM. Laparoscopic Spleen-Preserving Hilar Lymphadenectomy for Advanced Proximal Gastric Cancer Without Greater Curvature Invasion: Five-Year Outcomes From the Fuges-02 Randomized Clinical Trial. JAMA Surg. 2024 Jul 1;159(7):747-755. doi: 10.1001/jamasurg.2024.1023.
PubMed 38691353Lin JX, Lin JP, Wang ZK, Li P, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu RH, Lin GT, Huang ZN, Lin JL, Zheng HL, Lin GS, Huang CM, Zheng CH. Assessment of Laparoscopic Spleen-Preserving Hilar Lymphadenectomy for Advanced Proximal Gastric Cancer Without Invasion Into the Greater Curvature: A Randomized Clinical Trial. JAMA Surg. 2023 Jan 1;158(1):10-18. doi: 10.1001/jamasurg.2022.5307.
PubMed 36383362
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Long-term Outcome of Laparoscopic Spleen-Preserving D2 Lymphadenectomy With and Without No. 10 Lymph Node Dissection for Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02333721
- Acronym / sponsor ID
- LSPLN / FUGES-002
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Jan 2015 (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 the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature.
Detailed description
A prospective randomized comparison of laparoscopic spleen-preserving No. 10 lymph node dissection for gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function 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 |
|---|---|---|
| D2 Lymphadenectomy including No. 10 | Experimental | Procedure: D2 lymphadenectomy including No. 10Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group |
| D2 lymphadenectomy excluding No. 10 | Active comparator | Procedure: D2 lymphadenectomy excluding No. 10Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 to 75 years
- Primary proximal gastric adenocarcinoma not invading greater curvature (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
Key exclusion criteria (13 listed)
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by 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 |
|---|---|---|
| D2 lymphadenectomy including No. 10After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy | Procedure or surgery | D2 Lymphadenectomy including No. 10 |
| D2 lymphadenectomy excluding No. 10After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy | Procedure or surgery | D2 lymphadenectomy excluding No. 10 |
Primary outcome
3-year disease free survival rate
Time frame: 36 months
32 secondary outcomes
Morbidity and mortality
Time frame: 30 days; 36 months
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Time to first ambulation
Time frame: 10 days
Rates of splenectomy
Time frame: 1 day
Rates of injury to splenic vessels
Time frame: 1 day
The number of lymph node dissection
Time frame: 1 day
The variation of weight
Time frame: 12 months
The daily highest body temperature
Time frame: 7 days
Time to first flatus
Time frame: 10 days
Time to first liquid diet
Time frame: 10 days
Time to soft diet
Time frame: 10 days
Duration of hospital stay
Time frame: 10 days
The amount of abdominal drainage
Time frame: 10 days
Blood transfusion
Time frame: 10 days
The number of positive lymph nodes
Time frame: 1 day
Intraoperative lymph node dissection time
Time frame: 1 day
Intraoperative blood loss
Time frame: 1 day
Intraoperative injury
Time frame: 1 day
The amount of use of titanium clip
Time frame: 1 day
The rate of conversion to laparotomy
Time frame: 1 day
The variation of cholesterol
Time frame: 12 months
The variation of albumin
Time frame: 12 months
The results of endoscopy
Time frame: 12 months
The values of white blood cell count
Time frame: 7 days
The values of hemoglobin
Time frame: 7 days
The values of C-reactive protein
Time frame: 7 days
The values of prealbumin
Time frame: 7 days
The values of relevant immune cytokines
Time frame: 7 days
The Surgery Task Load Index (SURG-TLX)
Time frame: 1 days
Lymph node noncompliance rate
Time frame: 1 days
Technical performance
Time frame: 1 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 40850834Zhong Q, Zhang ZQ, Yan YQ, Li YF, He QC, Zheng CH, Chen QY, Huang CM. [Long-term oncological safety of robotic total gastrectomy for locally advanced proximal gastric cancer: a 5-year noninferiority comparison based on the FUGES-014 study]. Zhonghua Wei Chang Wai Ke Za Zhi. 2025 Aug 25;28(8):886-894. doi: 10.3760/cma.j.cn441530-20250610-00218. Chinese.
- Derived from this study: PubMed 38980664Xu BB, Zheng HL, Chen CS, Xu LL, Xue Z, Wei LH, Zheng HH, Shen LL, Zheng CH, Li P, Xie JW, Lin JX, Zheng YH, Huang CM. Development and validation of a preoperative radiomics-based nomogram to identify patients who can benefit from splenic hilar lymphadenectomy: a pooled analysis of three prospective trials. Int J Surg. 2024 Jul 1;110(7):4053-4061. doi: 10.1097/JS9.0000000000001337.
- Derived from this study: PubMed 38691353Lin JX, Xu BB, Zheng HL, Li P, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Yao ZH, Zheng CH, Huang CM. Laparoscopic Spleen-Preserving Hilar Lymphadenectomy for Advanced Proximal Gastric Cancer Without Greater Curvature Invasion: Five-Year Outcomes From the Fuges-02 Randomized Clinical Trial. JAMA Surg. 2024 Jul 1;159(7):747-755. doi: 10.1001/jamasurg.2024.1023.
- Derived from this study: PubMed 36383362Lin JX, Lin JP, Wang ZK, Li P, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu RH, Lin GT, Huang ZN, Lin JL, Zheng HL, Lin GS, Huang CM, Zheng CH. Assessment of Laparoscopic Spleen-Preserving Hilar Lymphadenectomy for Advanced Proximal Gastric Cancer Without Invasion Into the Greater Curvature: A Randomized Clinical Trial. JAMA Surg. 2023 Jan 1;158(1):10-18. doi: 10.1001/jamasurg.2022.5307.
- 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, M.D.,Ph.D. study chair
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 D2 lymphadenectomy including No. 10 and D2 lymphadenectomy excluding No. 10 in people with Stomach Neoplasms, 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 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 9 Sep 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, M.D., Ph.D. (+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?
On the ClinicalTrials.gov record for NCT02333721, which also lists 4 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 9 Sep 2020.