stomach cancer
Conditions
Interventions
Group A, totally laparoscopic distal gastrectomy:totally laparoscopic distal gastrectomy
Group B, laparoscopy-assisted distal gastrectomy:laparoscopy-assisted distal gastrectomy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Histologic proven gastric adenocarcinoma (by preoperative gastrofiberscopy) (2) Age between 20 and 80 years old (3) Eastern Cooperative Oncology Group performance status of 0 or 1 (4) Clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the American Joint Committee on Cancer system (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography) (5) Scheduled for laparoscopic distal gastrectomy with D1+ or D2 lymphadenectomy, and possible for R0 surgery by this procedure (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2010 (ver.3).) (6) Patients who gave a consent and signed the formal paper permitted by Institutional Review Board (IRB) after hearing a full description of the study (purpose and contents) prior to the participation
Exclusion criteria
Exclusion criteria: (1) Patients who received stomach surgery (i.e. gastrectomy or gastrojejunostomy) in the past (2) Patients with intraabdominal adhesion due to previous intraperitoneal surgery (3) Patients who recently diagnosed with gastric cancer and received either anticancer treatment or radiation therapy (4) Patients who require combined organ resection due to aggression of gastric cancer or other diseases (5) Patients who received surgeries due to primary cancer of other organs, or had anticancer treatment or radiation therapy in the last five years (patients whose skin basal cell carcinoma and insitu cervical cancer are completely cured are exceptions) (6) Vulnerable people who can’t communicate or are pregnant (or planning to be pregnant) (7) Patients who are currently participating or participated in other clinical trials in the last six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative 30-day morbidity rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative QOL Measurement:EORTC C30/STO22 questionnaire score; | — |
Countries
China
Contacts
Public Contacthuanghua
Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
Outcome results
None listed