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UMIN-CTR Clinical Trial |
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Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000003420 |
Receipt No. | R000004144 |
Scientific Title | Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III) |
Date of disclosure of the study information | 2010/03/31 |
Last modified on | 2022/04/10 |
Basic information | ||
Public title | Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III) | |
Acronym | Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III) | |
Scientific Title | Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III) | |
Scientific Title:Acronym | Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III) | |
Region |
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Condition | ||
Condition | Advanced gastric cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate oncological outcome of patients for advanced gastric cancer undergoing laparoscopic versus open surgery |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase II,III |
Assessment | |
Primary outcomes | phaseII: Incidence of anastomotic leakage or pancreatic fistula
phaseIII:relapse-free survival |
Key secondary outcomes | overall survival, proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes, number of retrieved lymph node, recurrent sites |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | A: Open distal gastrectomy with D2 lymph node dissection | |
Interventions/Control_2 | B: Laparoscopy assisted distal gastrectomy with D2 lymph node dissection | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | For inclusion in the study, patients must fulfill the following requirements preoperatively:
1) histologically proven gastric carcinoma 2) MP,SS or deeper lesion without involvement of other organs, N0-2 excluding bulky N2 and M0 according to the Japanese classification system 3) tumor located in the body and antrum of the stomach and indication for distal gastrectomy 4)No invasion to duodenum 5) Aged 20 to 80 year 6) PS (ECOG)0 or 1 7) Body mass index < 30 8) no history of gastrointestinal surgery 9) no history of chemotherapy or radiotherapy 10) Sufficient organ functions 11) provided written informed consent |
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Key exclusion criteria | 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ.
2) Women during pregnancy or breast-feeding. 3) Severe mental disease. 4) Continuous systemic steroid therapy. 5) History of myocardial infarction or unstable angina pectoris within six months. 6) Uncontrollable hypertension. 7) Uncontrollable diabetes millutus or administration of insulin. 8) Severe respiratory disease requiring continuous oxygen therapy. |
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Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Japanese Laparoscopic Surgery Study Group (JLSSG) | ||||||
Division name | Oita University | ||||||
Zip code | |||||||
Address | 1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan | ||||||
TEL | 097-586-5843 | ||||||
geka1@oita-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Japanese Laparoscopic Surgery Study Group (JLSSG) Coordinating Office | ||||||
Division name | Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine | ||||||
Zip code | |||||||
Address | 1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan | ||||||
TEL | 097-586-5843 | ||||||
Homepage URL | |||||||
geka1@oita-u.ac.jp |
Sponsor | |
Institute | Japanese Laparoscopic Surgery Study Group (JLSSG) |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
Funding Source | |
Organization | Japanese Laparoscopic Surgery Study Group (JLSSG) |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 大分大学医学部消化器・小児外科(大分県)
佐賀大学医学部附属病院一般・消化器外科(佐賀県) 福岡大学病院消化器外科(福岡県) 兵庫県立がんセンター消化器外科(兵庫県) 岩手医科大学外科(岩手県) 大阪医科大学一般・消化器外科(大阪府) 大阪大学医学部附属病院消化器外科(大阪府) 泉大津市立病院外科・内視鏡外科(大阪府) 名古屋大学医学部附属病院消化器外科(愛知県) 岐阜大学腫瘍外科(岐阜県) 長野市民病院外科(長野県) 慶應義塾大学病院外科(東京都) 東京医科歯科大学大学院腫瘍外科(東京都) 駿河台日本大学病院外科(東京都) 北里大学東病院外科(神奈川県) 石川県立中央病院消化器外科(石川県) 富山県済生会高岡病院外科(富山県) 函館五稜郭病院外科(北海道) 聖マリアンナ医科大学(東京都) 大阪市立総合医療センター消化器外科(大阪府) 福井県済生会病院外科(福井県) 九州大学臨床・腫瘍外科(福岡県) 愛媛大学消化管・腫瘍外科(愛媛県) 横浜市立大学附属市民総合医療センター消化器病センター(神奈川県) 岡山大学消化管外科(岡山県) 埼玉医科大学国際医療センター上部消化管外科(埼玉県) 静岡県立静岡がんセンター胃外科(静岡県) 愛知県がんセンター消化器外科(愛知県) 神戸大学食道・胃腸外科(兵庫県) 新潟市民病院消化器外科(新潟県) がん・感染症センター都立駒込病院外科(東京都) 近畿大学外科学内視鏡外科部門(大阪府) 大阪市立大学腫瘍外科(大阪府) 国立がん研究センター東病院胃外科(千葉県) 佐賀県医療センター好生館消化器外科(佐賀県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004144 |