Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer
NCT ID: NCT03007550
Last Updated: 2019-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
227 participants
INTERVENTIONAL
2017-01-04
2018-10-24
Brief Summary
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Detailed Description
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More than 20 years after the introduction of laparoscopic gastrectomy, many large-scale randomized controlled trials have been conducted in Japan (JCOG0912 and JLSSG0901), Korea (KLASS01 and KLASS02), and China (CLASS01). These trials are all designed to evaluate the non-inferiority of laparoscopic-assisted distal gastrectomy (LADG) to its open counterpart. No RCT for laparoscopic total gastrectomy (LTG) exists at this moment. The standardization of techniques for esophagojejunal anastomosis in LTG has been difficult even for experienced surgeons.
At present, Japan (JCOG1401), Korea (KLASS03), and Netherlands (STOMACH) have planned or launched clinical studies on LTG. China is one of the countries with the highest incidence of gastric cancer and surgeons have accumulated extensive experience through CLASS01 study. So, it's time for conducting the clinical research on the safety of LTG for gastric cancer.
This CLASS02-01 trial is a prospective, multicenter trial for 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopic total gastrectomy
The surgeon will perform LTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group.
Laparoscopic total gastrectomy
LTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
Open total gastrectomy
The surgeon will perform OTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group.
Open total gastrectomy
OTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
Interventions
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Laparoscopic total gastrectomy
LTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
Open total gastrectomy
OTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Yihong Sun
Clinical Professor,Department of General Surgery, Zhongshan Hospital
Principal Investigators
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Yihong Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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ZhongShan hospital FuDan university
Shanghai, Shanghai Municipality, China
Countries
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References
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Hu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22.
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Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.
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Other Identifiers
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ZSGC-001
Identifier Type: -
Identifier Source: org_study_id
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