Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer
NCT ID: NCT02845986
Last Updated: 2020-02-05
Study Results
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Basic Information
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UNKNOWN
PHASE2
251 participants
INTERVENTIONAL
2016-09-01
2020-10-12
Brief Summary
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Detailed Description
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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）.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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No.10 lymph node dissections
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.
Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections
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.
oxaliplatin
oxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery.
Interventions
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Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections
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.
oxaliplatin
oxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. Locally advanced tumor in the upper third stomach（cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Written informed consent
Exclusion Criteria
2. Suffering from severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
6. History of other malignant disease within the past 5 years
7. History of previous neoadjuvant chemotherapy or radiotherapy
8. History of unstable angina or myocardial infarction within the past 6 months
9. History of cerebrovascular accident within the past 6 months
10. History of continuous systematic administration of corticosteroids within 1 month
11. Requirement of simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. FEV1\<50% of the predicted values
14. Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.
18 Years
75 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Southwest Hospital, China
OTHER
Fujian Provincial Hospital
OTHER
Zhangzhou Municipal Hospital of Fujian Province
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
Fujian Medical University
OTHER
Responsible Party
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Chang-Ming Huang, Prof.
Professor
Principal Investigators
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Changming Huang, Professor
Role: PRINCIPAL_INVESTIGATOR
Fujian Medical University Union Hospital,China
Locations
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Beijing Cancer Hospital
Haidian, Beijing Municipality, China
Southwest Hospital
Shapingba, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Longyan First Hospital
Longyan, Fujian, China
The First Hospital of Putian City
Putian, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Jiangsu province hospital
Nanjing, Jiangsu, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Pudong, Shanghai Municipality, China
Shanghai Zhongshan Hospital
Xuhui, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, China
Countries
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References
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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.
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.
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.
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.
Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2016-01
Identifier Type: -
Identifier Source: org_study_id
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