Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer

This CLASS02-01 trial is a prospective, multicenter trial for laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

1. Aged 18-75 years；
2. Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
3. Clinical stage IA (T1N0M0) or IB (T1N1M0, T2N0M0) (According to AJCC-7th TNM staging system);
4. Tumor located in the upper or middle third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D1+/D2-10 lymphadenectomy (also apply to multiple primary cancers);
5. No invasion to Z-line;
6. BMI (Body Mass Index) \< 30 kg/m2;
7. No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
8. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.;
9. No enlargement of splenic hilar lymph nodes;
10. Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1;
11. Preoperative ASA (American Society of Anesthesiologists) scoring: I-III;
12. Sufficient organ functions;
13. Written informed consent.

Exclusion Criteria:

1. Preoperative examinations indicate that the stage of the disease is stage II/III/IV;
2. Preoperative examination indicate enlargement of perigastric or retroperitoneal lymph nodes (min diameter≥1.0cm);
3. Women during pregnancy or breast-feeding;
4. Synchronous or metachronous (within 5 years) malignancies;
5. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated;
6. Severe mental disease;
7. Severe respiratory disease;
8. Severe hepatic and renal dysfunction;
9. Unstable angina pectoris or history of myocardial infarction within 6 months;
10. History of cerebral infarction or cerebral hemorrhage within 6 months;
11. Continuous systemic steroid therapy within 1 month (except for topical use);
12. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery;
13. Patients are participating or have participated in another clinical trial (within 6 months).

• BACKGROUNDDindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. PMID 15273542
• BACKGROUNDKim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b. PMID 20160637
• BACKGROUNDChen K, Xu XW, Zhang RC, Pan Y, Wu D, Mou YP. Systematic review and meta-analysis of laparoscopy-assisted and open total gastrectomy for gastric cancer. World J Gastroenterol. 2013 Aug 28;19(32):5365-76. doi: 10.3748/wjg.v19.i32.5365. PMID 23983442
• BACKGROUNDKim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01). J Korean Surg Soc. 2013 Feb;84(2):123-30. doi: 10.4174/jkss.2013.84.2.123. Epub 2013 Jan 29. PMID 23396494
• BACKGROUNDNakamura K, Katai H, Mizusawa J, Yoshikawa T, Ando M, Terashima M, Ito S, Takagi M, Takagane A, Ninomiya M, Fukushima N, Sasako M. A phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric Cancer (JCOG0912). Jpn J Clin Oncol. 2013 Mar;43(3):324-7. doi: 10.1093/jjco/hys220. Epub 2012 Dec 28. PMID 23275644
• BACKGROUNDJeong O, Ryu SY, Choi WY, Piao Z, Park YK. Risk factors and learning curve associated with postoperative morbidity of laparoscopic total gastrectomy for gastric carcinoma. Ann Surg Oncol. 2014 Sep;21(9):2994-3001. doi: 10.1245/s10434-014-3666-x. Epub 2014 Apr 1.