RECRUITINGINTERVENTIONAL
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer
About This Trial
The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.
Who May Be Eligible (Plain English)
Who May Qualify:
1. histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
2. age between 20 and 80 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
5. scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
6. written willing to sign a consent form
7. without preoperative chemotherapy and radiotherapy
Who Should NOT Join This Trial:
1. clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
2. history of chemotherapy, radiotherapy, immunotherapy or target therapy
3. perigastric lymphnode≥3cm
4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
5. multiple primary tumors
6. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
7. patients need emergency operation with complication of gastric cancer
8. adhesion due to the previous intraabdominal surgery
9. need for combined organ resection due to aggression of gastric cancer of other disease,
10. vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
11. currently participating or participated in other clinical trials in the last 6 months
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
2. age between 20 and 80 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
5. scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
6. written informed consent
7. without preoperative chemotherapy and radiotherapy
Exclusion Criteria:
1. clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
2. history of chemotherapy, radiotherapy, immunotherapy or target therapy
3. perigastric lymphnode≥3cm
4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
5. multiple primary tumors
6. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
7. patients need emergency operation with complication of gastric cancer
8. adhesion due to the previous intraabdominal surgery
9. need for combined organ resection due to aggression of gastric cancer of other disease,
10. vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
11. currently participating or participated in other clinical trials in the last 6 months
Treatments Being Tested
PROCEDURE
Total Gastrectomy
The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China