Efficacy of Laparoscopic Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer
NCT ID: NCT01456598
Last Updated: 2018-11-29
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1050 participants
INTERVENTIONAL
2011-11-21
2018-06-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* In case of early stage of gastric cancer, as the diverse clinical evidences, the gastrectomy has been commonly applied, however, the opening surgery is still applied for advanced gastric cancer due to lack of clinical evidence.
* In Korea, approximately 38% of patients who undergo surgery for gastric cancer are diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer registration business in 2009). There are various clinical evidences to apply laparoscopic surgery to the patients, however, most of them are retrospective or cohort study results.
* For the clinical application of surgical treatment regarding locally advanced gastric cancer using laparoscopic surgical technique, it requires the confirmation of definite execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of surgery and oncological usefulness should be verified.
* In order for this, it is only possible to confirm through the comparison of short-term surgical results (complications, mortalities, operative time and duration of hospitalization etc) and long-term results (survival rates and recurrence rates etc) between laparoscopic surgery and opening surgery based on the multicenter large-sized randomized prospective study with current standard treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial
NCT00452751
Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy
NCT04658589
Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
NCT05556980
Clinical Study on Laparoscopic Gastrectomy for Early Gastric Cancer (COACT_0301)
NCT00546468
Standardization of D2 Lymphadenectomy and Surgical Quality Control: KLASS-02-QC
NCT01283893
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Prior to this clinical trial, only the surgeons who are considered to have the standardization by participating the assignment entitled with "KLASS-02-QC: Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial"(ClinicalTrials.gov No: NCT01283893).
Patients Registration
* It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
* After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Ajou University clinical trial center.
Randomization
* The registration randomization should be done with 1:1 ratio for each researcher.
* Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.
Procedure
* Operations are performed according to the allocated group.
Adjuvant Treatment
* If it is under Stage II and Stage III in the final postoperative pathology, the adjuvant chemotherapy based on 5-FU.
Evaluation of efficacy and safety
* 3-year Relapse free survival rate and overall survival rate of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.
* Analysis of recovery after laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.
* Postoperative complications of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection within postoperative 3 weeks and later.
* The quality of life at preoperative, postoperative 25 days and 1 years using recovery index such as recovery of postoperative intestinal hypermotility, meals and duration of hospitalization, EORTC-C30 and STO22 questionnaire between the patients who underwent laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Laparoscopic gastrectomy
Laparoscopic subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.
Laparoscopic gastrectomy
* After laparoscopic observation, the possibility of surgery can be considered by examining inside of abdomen.
* The surgeon undergoes laparoscopic subtotal gastrectomy and D2 lymph node dissection
* After lymph node dissection, it is possible to undergo gastrectomy on appropriate part and reconstruction under small incision or laparoscopic view.
* As the reconstruction, one of the techniques like Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.
Open gastrectomy
Open subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.
Open gastrectomy
* After laparotomy, the possibility of surgery can be considered by examining inside of abdomen.
* The surgeon undergoes open subtotal gastrectomy and D2 lymph node dissection
* After lymph node dissection, one of the techniques likes Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laparoscopic gastrectomy
* After laparoscopic observation, the possibility of surgery can be considered by examining inside of abdomen.
* The surgeon undergoes laparoscopic subtotal gastrectomy and D2 lymph node dissection
* After lymph node dissection, it is possible to undergo gastrectomy on appropriate part and reconstruction under small incision or laparoscopic view.
* As the reconstruction, one of the techniques like Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.
Open gastrectomy
* After laparotomy, the possibility of surgery can be considered by examining inside of abdomen.
* The surgeon undergoes open subtotal gastrectomy and D2 lymph node dissection
* After lymph node dissection, one of the techniques likes Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The patient with the capability for ECOG (Eastern Cooperative Oncology Group performance status) is ranged between 0 and 1
* The patient included between ASA score (American society of anesthesiology) class I and III
* The patient who is diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy
* The patient who is diagnosed as locally advanced gastric cancer with the suspicious infiltration of over muscular layer without infiltration on adjacent organs, and without or with lymph node metastasis limited to perigastric or around stomach left gastric artery at the preoperative examination.
* The patient who is suitable for subtotal resection in the preoperative examination
* The patient who is fully explained about purpose of trial and contents prior to the participation into this study and signed on the informed consent approved by Institutional Review Board according to own opinion
Exclusion Criteria
* The patient with medical history for gastrectomy in the past
* The patient with complication (complete obstruction and perforation) by gastric cancer
* The patient who undergoes anticancer or radiologic therapy prior to the operation or who undergoes endoscopic submucous dissection for currently diagnosed gastric cancer
* The patient who undergoes surgery or anti-cancer radiologic therapy for primary cancer within 5 years
* Vulnerable patients (lack of capacity for decision making, pregnant women (or under planning))
* The patient who has participated into another clinical trial within recent 6 months or who is participating into another trial
* The patient with double cancer of activity and synchronization
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ajou University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sang-Uk Han
Professor, Department of Surgery, Ajou University School of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
San-Uk Han, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Ajou University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Surgery , SOON CHUN HYANG UNIVESITY HOSPITAL
Bucheon-si, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Copyright National Cancer Center
Goyang-si, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Incheon St, Mary's Hostpial, The Catholic University of Korea
Incheon, , South Korea
Dong-A University Hospital
Pusan, , South Korea
Department of Surgery, Seoul National University BUNDANG Hospital
Seongnam, , South Korea
Department of Surgery, Seoul National University Hospital
Seoul, , South Korea
Yonsei University Severance Hospital
Seoul, , South Korea
Yeoeuido St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Department of surgery, GANGNAM SEVERANCE HOSPITAL
Seoul, , South Korea
EWHA Womans university medical center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
Kim W, Song KY, Lee HJ, Han SU, Hyung WJ, Cho GS. The impact of comorbidity on surgical outcomes in laparoscopy-assisted distal gastrectomy: a retrospective analysis of multicenter results. Ann Surg. 2008 Nov;248(5):793-9. doi: 10.1097/SLA.0b013e3181887516.
Kim 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.
Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.
Son SY, Hur H, Hyung WJ, Park YK, Lee HJ, An JY, Kim W, Kim HI, Kim HH, Ryu SW, Kim MC, Kong SH, Cho GS, Kim JJ, Park DJ, Ryu KW, Kim YW, Kim JW, Lee JH, Yang HK, Han SU; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: 5-Year Outcomes of the KLASS-02 Randomized Clinical Trial. JAMA Surg. 2022 Oct 1;157(10):879-886. doi: 10.1001/jamasurg.2022.2749.
Hyung WJ, Yang HK, Park YK, Lee HJ, An JY, Kim W, Kim HI, Kim HH, Ryu SW, Hur H, Kim MC, Kong SH, Cho GS, Kim JJ, Park DJ, Ryu KW, Kim YW, Kim JW, Lee JH, Han SU; Korean Laparoendoscopic Gastrointestinal Surgery Study Group. Long-Term Outcomes of Laparoscopic Distal Gastrectomy for Locally Advanced Gastric Cancer: The KLASS-02-RCT Randomized Clinical Trial. J Clin Oncol. 2020 Oct 1;38(28):3304-3313. doi: 10.1200/JCO.20.01210. Epub 2020 Aug 20.
Related Links
Access external resources that provide additional context or updates about the study.
Institutional Review Board, Ajou University Hospital
The Korean Gastric Cancer Association
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AJIRB-MED-MDB-11-233
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.