Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Esophagogastric Junction Cancer
NCT ID: NCT04443478
Last Updated: 2021-12-02
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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RECRUITING
1036 participants
OBSERVATIONAL
2020-08-01
2026-07-01
Brief Summary
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Detailed Description
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Methods and analysis: This is an IDEAL stage II, prospective, parallel control, open label, multi-center and exploratory study. The inclusion criteria is Siewert II/ III, AEJ, cT2-4aN0-3M0(AJCC-8th Gastric Cancer TNM stage manual), decide to receive radical gastrectomy, without preoperative anti-neoplastic therapy. The individual included in the study is performed the radical total or proximal gastrectomy plus the lower mediastinal lymphadenectomy via either laparoscopic (trial arm) or open (control arm) TH approach. The surgical approach is determined by the investigator in each center before the operation and recorded in the electronic case report forms (CRF).
The primary outcome is the number of lower mediastinal lymph nodes retrieved. Secondary outcome include complication, surgery length, postoperative death, R0 resection rate, etc. Expected sample size is 518 in each group, thus has 80% power to detect a difference of 0.17 in the average number of lower mediastinal lymph node dissected in between two groups.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Laparoscopic Surgery
Lower Mediastinal Lymphadenectomy should be finished via laparoscopic method.
Radical gastrectomy with dissection of lower mediastinal lymph node
Radical gastrectomy for gastric cancer should be consistent with Japanese gastric cancer treatment guideline.
Open Surgery
Lower Mediastinal Lymphadenectomy should be finished via open method.
Radical gastrectomy with dissection of lower mediastinal lymph node
Radical gastrectomy for gastric cancer should be consistent with Japanese gastric cancer treatment guideline.
Interventions
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Radical gastrectomy with dissection of lower mediastinal lymph node
Radical gastrectomy for gastric cancer should be consistent with Japanese gastric cancer treatment guideline.
Eligibility Criteria
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Inclusion Criteria
* Karnofsky score ≥70%;Or ECOG score ≤2;
* Preoperative pathological biopsy confirmed adenocarcinoma.
* According to gastroscopy, abdominal CT or upper gastrointestinal angiography, the tumor site conforms to the definition of esophageal and gastric junction adenocarcinoma in the "Chinese expert consensus", that is, the tumor center is within 5cm above and below the esophagogastric anatomical junction and crosses or touches the esophagogastric junction;
* Length of esophageal invasion ≤2cm;
* By abdominal contrast-enhanced CT/MRI, the clinical stage was CT2-4aN0-3M0 (according to AJCC-8th TNM tumor stage);
* Subject's blood routine and biochemical indicators meet the following standards: hemoglobin ≥80g/L; Absolute count of neutrophils (ANC) ≥1.5×109/L; Platelet ≥75×109/L;ALT and AST≤2.5 times the normal upper limit; ALP≤2.5 times the normal upper limit; Serum total bilirubin ≤1.5 times the normal upper limit; Serum creatinine ≤ the normal upper limit; Serum albumin ≥30g/L;
* Obtain written informed consent.
Exclusion Criteria
* Multiple malignant lesions in the stomach.
* Suspicious lymph node metastasis in the middle and/or upper mediastinum.
* Surgical history in the upper abdomen (laparoscopic cholecystectomy excluded).
* Pregnant or breastfeeding women.
* Uncontrolled epilepsy, central nervous system disease or mental disorder.
* The Bulky N2 status.
* The emergency surgery.
* Severe heart disease.
* History of cerebral infarction or cerebral hemorrhage within 6 months.
* Organ transplant recipients who need immunosuppressive therapies.
* Other malignancy diagnosed within 5 years (cured dermoid caner and cervical cancer excluded).
18 Years
80 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Changzhi People's Hospital
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
Fujian Medical University Union Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Fudan University
OTHER
Guangdong Provincial People's Hospital
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Hebei Medical University Fourth Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
The First Hospital of Jilin University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
The First Affiliated Hospital of Air Force Medicial University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Affiliated Hospital of Qinghai University
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Shandong Provincial Hospital
OTHER_GOV
Shanxi Province Cancer Hospital
OTHER
RenJi Hospital
OTHER
Ruijin Hospital
OTHER
Beijing Friendship Hospital
OTHER
West China Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Zhejiang Cancer Hospital
OTHER
Chinese PLA General Hospital
OTHER
First Hospital of China Medical University
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Sun Yat-sen University
OTHER
Peking University
OTHER
Responsible Party
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Jiafu Ji
President of Beijing Cancer Hospital
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Fei Shan, MD
Role: primary
Zhemin Li, MD
Role: backup
References
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Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
Markar SR, Dabakuyo-Yonli TS, Piessen G. Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer. Reply. N Engl J Med. 2019 Apr 25;380(17):e28. doi: 10.1056/NEJMc1901650. No abstract available.
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.
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.
Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.
Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.
Kurokawa Y, Takeuchi H, Doki Y, Mine S, Terashima M, Yasuda T, Yoshida K, Daiko H, Sakuramoto S, Yoshikawa T, Kunisaki C, Seto Y, Tamura S, Shimokawa T, Sano T, Kitagawa Y. Mapping of Lymph Node Metastasis From Esophagogastric Junction Tumors: A Prospective Nationwide Multicenter Study. Ann Surg. 2021 Jul 1;274(1):120-127. doi: 10.1097/SLA.0000000000003499.
Sugita S, Kinoshita T, Kaito A, Watanabe M, Sunagawa H. Short-term outcomes after laparoscopic versus open transhiatal resection of Siewert type II adenocarcinoma of the esophagogastric junction. Surg Endosc. 2018 Jan;32(1):383-390. doi: 10.1007/s00464-017-5687-6. Epub 2017 Jun 27.
Sugita S, Kinoshita T, Kuwata T, Tokunaga M, Kaito A, Watanabe M, Tonouchi A, Sato R, Nagino M. Long-term oncological outcomes of laparoscopic versus open transhiatal resection for patients with Siewert type II adenocarcinoma of the esophagogastric junction. Surg Endosc. 2021 Jan;35(1):340-348. doi: 10.1007/s00464-020-07406-w. Epub 2020 Feb 5.
Huang CM, Lv CB, Lin JX, Chen QY, Zheng CH, Li P, Xie JW, Wang JB, Lu J, Cao LL, Lin M, Tu RH. Laparoscopic-assisted versus open total gastrectomy for Siewert type II and III esophagogastric junction carcinoma: a propensity score-matched case-control study. Surg Endosc. 2017 Sep;31(9):3495-3503. doi: 10.1007/s00464-016-5375-y. Epub 2016 Dec 15.
Li S, Ying X, Shan F, Jia Y, Li Z, Xue K, Miao R, Wang Y, Bu Z, Su X, Li Z, Ji J. Laparoscopic vs. open lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction: An exploratory, observational, prospective, IDEAL stage 2b cohort study (CLASS-10 study). Chin J Cancer Res. 2022 Aug 30;34(4):406-414. doi: 10.21147/j.issn.1000-9604.2022.04.08.
Other Identifiers
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CLASS-10
Identifier Type: -
Identifier Source: org_study_id