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document
A phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric Cancer ( JCOG0912 ) . A Phase III study was started in Japan to evaluate the non-inferiority of overall survival of laparoscopy-assisted distal gastrectomy with open distal gastrectomy in patients with clinical IA ( T1N0 ) or IB [ T1N1 or T2 ( MP ) N0 ] gastric cancer . This study followed the previous Phase II study to confirm the safety of laparoscopy-assisted distal gastrectomy ( JCOG0703 ) and began in March 2010 . A total of 920 patients will be accrued from 33 institutions within 5 years . The primary endpoint is overall survival . The secondary endpoints are relapse-free survival , proportion of laparoscopy-assisted distal gastrectomy completion , proportion of conversion to open surgery , adverse events , short-term clinical outcomes , postoperative quality of life . Only a credentialed surgeon can be responsible for both open distal gastrectomy and laparoscopy-assisted distal gastrectomy .
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Intervention_Physical
laparoscopy-assisted
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Intervention_Surgical
open
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Intervention_Physical
distal gastrectomy
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Intervention_Surgical
laparoscopy-assisted distal gastrectomy
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Intervention_Surgical
open distal gastrectomy
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Intervention_Surgical
laparoscopy-assisted distal gastrectomy
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Intervention_Surgical
laparoscopy-assisted distal gastrectomy
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Intervention_Surgical
surgery
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Intervention_Surgical
open distal gastrectomy
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Intervention_Surgical
laparoscopy-assisted distal gastrectomy
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Outcome_Mortality
overall survival
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Outcome_Mortality
relapse-free survival
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Outcome_Other
proportion of laparoscopy-assisted distal gastrectomy completion
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Outcome_Other
proportion of conversion to open surgery
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Outcome_Adverse-effects
adverse events
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Outcome_Physical
short-term clinical outcomes
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Outcome_Other
postoperative quality of life
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Participant_Condition
open distal gastrectomy in patients with clinical IA ( T1N0 ) or IB [ T1N1
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Participant_Condition
T2 ( MP ) N0 ] gastric cancer .
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Participant_Sample-size
920 patients