Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| Southwest Hospital, China | OTHER |
| Fujian Provincial Hospital | OTHER |
| Zhangzhou Municipal Hospital of Fujian Province |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to explore the safety and feasibility of the Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.
Radical resection is still the primary method of treating advanced gastric cancer.According to the Japanese treatment guidelines for gastric cancer, D2 lymphadenectomy, including No. 10 lymph node dissection, should be adopted for upper third gastric carcinoma.The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally advanced upper third gastric cancer including No. 10 lymph node is the standard surgical treatment.
In the early, splenectomy was performed to remove No. 10 lymph node. With the improvement of medical knowledge and surgical technique, spleen-preserving No. 10 lymph node dissection has been recognized by more and more surgeons. However, due to the special and complex anatomy of the spleen, spleen-preserving No. 10 lymph node dissection is difficult, even in open surgery; consequently, the surgery cannot be performed in many centers.
Laparoscopic surgery has distinct minimally invasive advantages, such as small incisions, less blood loss, less postoperative pain, mild postoperative inflammatory reactions, a quick recovery of gastrointestinal function, shorter hospital stays and obvious cosmetic effects. Since Kitano et al. first reported laparoscopic gastrectomy for gastric cancer in 1994, laparoscopic techniques have developed rapidly. The techniques are becoming increasingly mature, making it possible to perform laparoscopic spleen-preserving No. 10 lymph node dissection. Our center first proposed "Huang's three-step maneuver", a new operative method suitable for laparoscopic spleen-preserving No. 10 lymph node dissection. This method simplifies the procedure of laparoscopic spleen-preserving No. 10 lymph node dissection and facilitates its popularization and promotion.
However, it remains a controversial international issue if it is safe and feasible to routinely conduct laparoscopic spleen-preserving No. 10 lymph node dissection for advanced upper third gastric cancer.A number of retrospective studies have successively confirmed the safety, feasibility and oncological efficacy of laparoscopic spleen-preserving No. 10 lymph node dissection.But there is no multicenter prospective studies to identify the results.
Therefore, The study is through a prospective, multicenter, open, single-arm, non-inferiority study,to explore the safety and feasibility of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No.10 lymph node dissections | Experimental | Patients with locally advanced upper third gastric carcinoma will performed laparoscopic spleen-preserving No.10 lymph node dissections.After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Laparoscopic spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma. |
| Measure | Description | Time Frame |
|---|---|---|
| overall postoperative morbidity rates | Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of No.10 lymph node dissection | Numbers of dissected No.10 lymph nodes | 9 days |
| Rates of positive No.10 lymph node | The Rates of positive No.10 lymph node are defined as the incidence of positive No.10 lymph node (divide number of positive No.10 lymph nodes by number of total No.10 lymph nodes). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Changming Huang, Professor | Fujian Medical University Union Hospital,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Haidian | Beijing Municipality | 100142 | China | ||
| Southwest Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21573742 | Result | Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available. | |
| 11223832 | Result | Monig SP, Collet PH, Baldus SE, Schmackpfeffer K, Schroder W, Thiele J, Dienes HP, Holscher AH. Splenectomy in proximal gastric cancer: frequency of lymph node metastasis to the splenic hilus. J Surg Oncol. 2001 Feb;76(2):89-92. doi: 10.1002/1096-9098(200102)76:23.0.co;2-i. |
Not provided
Not provided
There is no plan to make individual participant data (IPD) available.
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Meizhou People's Hospital | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
| Second Hospital of Jilin University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Affiliated Hospital of Qinghai University | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| RenJi Hospital | OTHER |
| West China Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| The First Hospital of Putian City, Putian, Fujian | OTHER_GOV |
| Longyan City First Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| oxaliplatin | Drug | oxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery. |
|
|
| 9 days |
| 3-year overall survival rate | 36 months |
| 3-year disease free 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 |
| Rates of splenectomy | The Rates of splenectomy are defined as the incidence of splenectomy within operation. | 1 days |
| Intraoperative morbidity rates | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. | 1 days |
| Time to first ambulation | Time to first ambulation in hours is used to assess the postoperative recovery course. | 30 days |
| Time to first flatus | Time to first flatus in days is used to assess the postoperative recovery course. | 30 days |
| Time to first liquid diet | Time to first liquid diet in days is used to assess the postoperative recovery course. | 30 days |
| Time to first soft diet | Time to first soft diet in days is used to assess the postoperative recovery course. | 30 days |
| Duration of postoperative hospital stay | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days |
| Postoperative pain | Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course. | 30 days |
| The variation of weight | The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. | 3, 6, 9 and 12 months |
| The variation of cholesterol | The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. | 3, 6, 9 and 12 months |
| The variation of album | The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. | 3, 6, 9 and 12 months |
| The results of endoscopy | The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life. | 3 and 12 months |
| The variation of body temperature | The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response. | 8 days |
| The variation 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 to access the inflammatory and immune response. | Preoperative 3 days and postoperative 1, 3, and 5 days |
| The variation of hemoglobin | The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. | Preoperative 3 days and postoperative 1, 3, and 5 days |
| The variation of C-reactive protein | The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. | Preoperative 3 days and postoperative 1, 3, and 5 days |
| The variation of prealbumin | The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. | Preoperative 3 days and postoperative 1, 3, and 5 days |
| Shapingba |
| Chongqing Municipality |
| 400038 |
| China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| Fujian Provincial Hospital | Fuzhou | Fujian | 350001 | China |
| Longyan First Hospital | Longyan | Fujian | 364000 | China |
| The First Hospital of Putian City | Putian | Fujian | 351100 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | Fujian | 363000 | China |
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Meizhou People's Hospital | Meizhou | Guangdong | 514031 | China |
| Jiangsu province hospital | Nanjing | Jiangsu | 210029 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130041 | China |
| Qinghai University Affiliated Hospital | Xining | Qinghai | 810001 | China |
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Pudong | Shanghai Municipality | 200135 | China |
| Shanghai Zhongshan Hospital | Xuhui | Shanghai Municipality | 200032 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | 710061 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Xinjiang | Xinjiang | 830054 | China |
| 15783049 | Result | Chikara K, Hiroshi S, Masato N, Goro M, Yuichi O, Hidetaka O, Hirotoshi A. Association of the number of metastatic perigastric lymph nodes with long-term survival in gastric cancer. Hepatogastroenterology. 2005 Jan-Feb;52(61):277-80. |
| 10089184 | Result | Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202. |
| 8180768 | Result | Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. |
| 18656040 | Result | Hyung WJ, Lim JS, Song J, Choi SH, Noh SH. Laparoscopic spleen-preserving splenic hilar lymph node dissection during total gastrectomy for gastric cancer. J Am Coll Surg. 2008 Aug;207(2):e6-11. doi: 10.1016/j.jamcollsurg.2008.04.027. No abstract available. |
| 20610241 | Result | Okabe H, Obama K, Kan T, Tanaka E, Itami A, Sakai Y. Medial approach for laparoscopic total gastrectomy with splenic lymph node dissection. J Am Coll Surg. 2010 Jul;211(1):e1-6. doi: 10.1016/j.jamcollsurg.2010.04.006. No abstract available. |
| 18095269 | Result | Hur H, Jeon HM, Kim W. Laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced (cT2) upper-third gastric cancer. J Surg Oncol. 2008 Feb 1;97(2):169-72. doi: 10.1002/jso.20927. |
| 11754382 | Result | Schwarz RE. Spleen-preserving splenic hilar lymphadenectomy at the time of gastrectomy for cancer: technical feasibility and early results. J Surg Oncol. 2002 Jan;79(1):73-6. doi: 10.1002/jso.10036. No abstract available. |
| 17058319 | Result | Tanimura S, Higashino M, Fukunaga Y, Kishida S, Ogata A, Fujiwara Y, Osugi H. Laparoscopic gastrectomy with regional lymph node dissection for upper gastric cancer. Br J Surg. 2007 Feb;94(2):204-7. doi: 10.1002/bjs.5542. |
| 24826062 | Result | Huang CM, Chen QY, Lin JX, Zheng CH, Li P, Xie JW. Huang's three-step maneuver for laparoscopic spleen-preserving No. 10 lymph node dissection for advanced proximal gastric cancer. Chin J Cancer Res. 2014 Apr;26(2):208-10. doi: 10.3978/j.issn.1000-9604.2014.04.05. |
| 22752074 | Result | Jung MR, Park YK, Seon JW, Kim KY, Cheong O, Ryu SY. Definition and classification of complications of gastrectomy for gastric cancer based on the accordion severity grading system. World J Surg. 2012 Oct;36(10):2400-11. doi: 10.1007/s00268-012-1693-y. |
| 24399492 | Result | Orsenigo E, Bissolati M, Socci C, Chiari D, Muffatti F, Nifosi J, Staudacher C. Duodenal stump fistula after gastric surgery for malignancies: a retrospective analysis of risk factors in a single centre experience. Gastric Cancer. 2014 Oct;17(4):733-44. doi: 10.1007/s10120-013-0327-x. Epub 2014 Jan 8. |
| 16003309 | Result | Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001. |
| 11091234 | Result | Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x. |
| 20113944 | Result | Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18. |
| 11712875 | Result | Arozullah AM, Khuri SF, Henderson WG, Daley J; Participants in the National Veterans Affairs Surgical Quality Improvement Program. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001 Nov 20;135(10):847-57. doi: 10.7326/0003-4819-135-10-200111200-00005. |
| 1334988 | Result | Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available. |
| 16643334 | Result | Dong K, Yu XJ, Li B, Wen EG, Xiong W, Guan QL. Advances in mechanisms of postsurgical gastroparesis syndrome and its diagnosis and treatment. Chin J Dig Dis. 2006;7(2):76-82. doi: 10.1111/j.1443-9573.2006.00255.x. |
| 11289756 | Result | Kaas R, Rustman LD, Zoetmulder FA. Chylous ascites after oncological abdominal surgery: incidence and treatment. Eur J Surg Oncol. 2001 Mar;27(2):187-9. doi: 10.1053/ejso.2000.1088. |
| 18685899 | Result | Assumpcao L, Cameron JL, Wolfgang CL, Edil B, Choti MA, Herman JM, Geschwind JF, Hong K, Georgiades C, Schulick RD, Pawlik TM. Incidence and management of chyle leaks following pancreatic resection: a high volume single-center institutional experience. J Gastrointest Surg. 2008 Nov;12(11):1915-23. doi: 10.1007/s11605-008-0619-3. Epub 2008 Aug 7. |
| 21336514 | Result | Greenblatt DY, Kelly KJ, Rajamanickam V, Wan Y, Hanson T, Rettammel R, Winslow ER, Cho CS, Weber SM. Preoperative factors predict perioperative morbidity and mortality after pancreaticoduodenectomy. Ann Surg Oncol. 2011 Aug;18(8):2126-35. doi: 10.1245/s10434-011-1594-6. Epub 2011 Feb 20. |
| 38980664 | Derived | 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. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D007287 | Inorganic Chemicals |
Not provided
Not provided