Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
LSPLN
Study on Long-term Outcome of Laparoscopic Spleen-Preserving D2 Lymphadenectomy With and Without No. 10 Lymph Node Dissection for Advanced Gastric Cancer
1 other identifier
interventional
536
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 9, 2020
September 1, 2020
6.9 years
December 25, 2014
September 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year disease free survival rate
36 months
Secondary Outcomes (32)
Morbidity and mortality
30 days; 36 months
3-year overall survival rate
36 months
3-year recurrence pattern
36 months
Time to first ambulation
10 days
Rates of splenectomy
1 day
- +27 more secondary outcomes
Study Arms (2)
D2 Lymphadenectomy including No. 10
EXPERIMENTALLaparoscopic 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 COMPARATORLaparoscopic 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Related Publications (4)
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.
PMID: 40850834DERIVEDXu 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.
PMID: 38980664DERIVEDLin 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.
PMID: 38691353DERIVEDLin 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.
PMID: 36383362DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Changming Huang, M.D.,Ph.D.
Fujian Medical University Union Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
December 25, 2014
First Posted
January 7, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
September 9, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share