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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02930291
Other study ID # 2016YF017-02
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2016
Est. completion date October 2020

Study information

Verified date February 2020
Source Fujian Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to explore the effect of preoperative inflammation-based scores on postoperative morbidity and mortality for laparoscopic gastrectomy.


Description:

A prospective cohort study will be performed to explore the effect of preoperative inflammation-based scores on postoperative morbidity and mortality for laparoscopic gastrectomy.The evaluation parameters are perioperative clinical efficacy, postoperative complications and 3-year survival and recurrence rates.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 310
Est. completion date October 2020
Est. primary completion date October 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Fujian Medical University Union Hospital Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 3-year disease free survival rate 36 months
Secondary 3-year disease overall survival rate 36 months
Secondary Morbidity and mortality The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th. 30 days; 36 months
Secondary 3-year recurrence pattern 36 months
Secondary Time to first ambulation The data of postoperative recovery course. 10 days
Secondary The number of lymph node dissection 1 day
Secondary The variation of weight The variation of weight on postoperative 3, 6, 9 and 12 months 12 months
Secondary The daily highest body temperature The daily highest body temperature before discharge 7 day
Secondary Time to first flatus 10 days
Secondary Time to first liquid diet 10 days
Secondary Time to soft diet 10 days
Secondary Duration of hospital stay 10 days
Secondary Intraoperative lymph node dissection time intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph 1 days
Secondary The amount of abdominal drainage 10 days
Secondary Blood transfusion 10 days
Secondary The number of positive lymph nodes 1 day
Secondary Intraoperative morbidity rates The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. 1 day
Secondary The rate of conversion to laparotomy 1 day
Secondary The variation of cholesterol The variation of cholesterol on postoperative 3, 6, 9 and 12 months 12 months
Secondary The variation of albumin The variation of albumin on postoperative 3, 6, 9 and 12 months 12 months
Secondary The results of endoscopy the results of endoscopy on postoperative 3 and 12 months 12 months
Secondary The values of white blood cell count 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. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The values of lymphocyte count 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. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The values of neutrophil differential count 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. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The values of platelet count The values of platelet count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The values of hemoglobin 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. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The values of C-reactive protein 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. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The values of prealbumin 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. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary Visual Analog Score for pain the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded. 7 days
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