Stomach Neoplasms
Conditions
Brief summary
The purpose of this study is to explore the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy.
Detailed description
A prospective cohort study will be performed to explore the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy.The evaluation parameters are perioperative clinical efficacy, postoperative complications and 3-year survival and recurrence rates.
Interventions
None listed
Sponsors
Fujian Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age from 18 to 75 years * Primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition * No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor. * Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) * American Society of Anesthesiology score (ASA) class I, II, or III * Written informed consent
Exclusion criteria
* Women during pregnancy or breast-feeding * Severe mental disorder * History of previous upper abdominal surgery (except laparoscopic cholecystectomy) * History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * Enlarged or bulky regional lymph node envelop important vessels * History of other malignant disease within past five years * History of previous neoadjuvant chemotherapy or radiotherapy * History of unstable angina or myocardial infarction within past six months * History of cerebrovascular accident within past six months * History of continuous systematic administration of corticosteroids within one month * Requirement of simultaneous surgery for other disease * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * FEV1\<50% of predicted values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease overall survival rate | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate | 36 months | — |
| 3-year recurrence pattern | 36 months | — |
| Time to first ambulation | 10 days | The data of postoperative recovery course. |
| The number of lymph node dissection | 1 day | — |
| The variation of weight | 12 months | The variation of weight on postoperative 3, 6, 9 and 12 months |
| The daily highest body temperature | 7 day | The daily highest body temperature before discharge |
| Time to first flatus | 10 days | — |
| Time to first liquid diet | 10 days | — |
| Time to soft diet | 10 days | — |
| Duration of hospital stay | 10 days | — |
| Intraoperative lymph node dissection time | 1 days | intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node and jejunal lymph nodes adjacent to the anastomosis. |
| The amount of abdominal drainage | 10 days | — |
| Blood transfusion | 10 days | — |
| The number of positive lymph nodes | 1 day | — |
| overall postoperative morbidity rates | 30 days | Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery. |
| The rate of conversion to laparotomy | 1 day | — |
| The variation of cholesterol | 12 months | The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. |
| The variation of albumin | 12 months | The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. |
| The results of endoscopy | 12 months | the results of endoscopy on postoperative 3 and 12 months |
| The values of white blood cell count | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| The values of lymphocyte count | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of lymphocyte count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| The values of monocyte count | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of monocyte count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| The values of neutrophil differential count | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of neutrophil differential count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| The values of platelet count | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of platelet count count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| The values of hemoglobin | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| The values of C-reactive protein | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| The values of prealbumin | Preoperative 3 days and postoperative 1, 3, and 5 days | The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. |
| Visual Analog Score for pain | 7 days | the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded. |
| Intraoperative morbidity rates | 1 day | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. |
Countries
China
Outcome results
None listed