Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study on Long-term Outcome of Laparoscopic Spleen-Preserving D2 Lymphadenectomy With and Without No. 10 Lymph Node Dissection for Advanced Gastric Cancer

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Procedure: D2 lymphadenectomy including No. 10
* Procedure: D2 lymphadenectomy excluding No. 10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D2 Lymphadenectomy including No. 10<br>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 | Procedure: D2 lymphadenectomy including No. 10<br>* 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<br>|
| Active Comparator: D2 lymphadenectomy excluding No. 10<br>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 | Procedure: D2 lymphadenectomy excluding No. 10<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach Neoplasms, Laparoscopy