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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D2 lymphadenectomy including No. 10 | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days; 36 months |
| 3-year overall survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changming Huang, M.D., Ph.D. | Contact | +86-138-0506-9676 | hcmlr2002@163.com | |
| Qiyue Chen, M.D. | Contact | +86-159-8023-5636 | 690934662@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Changming Huang, M.D.,Ph.D. | Fujian Medical University Union Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40850834 | Derived | 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. | |
| 38980664 |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| D2 lymphadenectomy excluding No. 10 | Procedure | 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 |
|
3-year overall survival rate |
| 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 | 36 months |
| Time to first ambulation | The data of postoperative recovery course. | 10 days |
| Rates of splenectomy | splenectomy performing by severe injury to the splenic vessels | 1 day |
| Rates of injury to splenic vessels | intraoperative injury to the splenic vessels | 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 | 1 day |
| The variation of weight | The variation of weight on postoperative 3, 6, 9 and 12 months | 12 months |
| The daily highest body temperature | The daily highest body temperature before discharge | 7 days |
| Time to first flatus | The time to first flatus | 10 days |
| Time to first liquid diet | The time to first liquid diet | 10 days |
| Time to soft diet | The time to soft diet | 10 days |
| Duration of hospital stay | Duration of hospital stay | 10 days |
| The amount of abdominal drainage | The amount of abdominal drainage | 10 days |
| Blood transfusion | Perioperative blood transfusion | 10 days |
| The number of positive lymph nodes | The number of positive lymph nodes | 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) | 1 day |
| Intraoperative blood loss | Intraoperative blood loss | 1 day |
| Intraoperative injury | Intraoperative injury | 1 day |
| The amount of use of titanium clip | The amount of use of titanium clip | 1 day |
| The rate of conversion to laparotomy | The rate of conversion to laparotomy | 1 day |
| The variation of cholesterol | The variation of cholesterol on postoperative 3, 6, 9 and 12 months | 12 months |
| The variation of albumin | The variation of albumin on postoperative 3, 6, 9 and 12 months | 12 months |
| The results of endoscopy | the results of endoscopy on postoperative 3 and 12 months | 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. | 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. | 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. | 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. | 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. | 7 days |
| The Surgery Task Load Index (SURG-TLX) | Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure. | 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. | 1 days |
| Technical performance | Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool. | 1 days |
| Xu 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. |
| 38691353 | Derived | Lin 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. |
| 36383362 | Derived | Lin 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. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |