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| ID | Type | Description | Link |
|---|---|---|---|
| D141100000414004 | Other Grant/Funding Number | Beijing Municipal Science & Technology Commission |
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RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for gastric cancer, yet the efficiency have not been fully investigated in Chinese people.
PURPOSE: Study the effectiveness of laparoscopic staging in patients with pre-diagnosed as locally advanced gastric cancer.
OBJECTIVES: I. Determine the feasibility of laparoscopic staging of patients with pre-diagnosed as locally advanced gastric cancer. II. Assess the adverse effects associated with this technique.
OUTLINE: Surgery. Laparoscopy with cytologic examination.
PROJECTED ACCRUAL: Up to 450 patients will be accrued over approximately 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Staging | Experimental | For Patients diagnosed as Locally Advanced Gastric Cancer(cT2+NanyM0)by CT and EUS, undergo laparoscopic staging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Staging | Procedure | Laparoscopic Staging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peritoneal Metastasis or Positive Cytology | 7days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Number of Participants with Adverse Events(III or IV grades according to NCI-CTC) | 30days |
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Inclusion Criteria:
Hematologic ANC ≥ 1.5*109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100*109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN Renal Serum Creatinine < 1.5 ULN
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiafu Ji, MD | Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Unicersity Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29321007 | Derived | Li Z, Li Z, Zhang L, Liu Q, Wang Z, Zhang Z, Xiao G, Fu W, Wang X, Ye Y, Yu J, Li F, Chen L, Wang S, Ji J. Staging laparoscopy for locally advanced gastric cancer in Chinese patients: a multicenter prospective registry study. BMC Cancer. 2018 Jan 10;18(1):63. doi: 10.1186/s12885-017-3791-6. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |