The Effect of Preoperative Hemotologic Markers on Postoperative Long-term and Short-term Outcomes for Laparoscopic Gastrectomy

The Effect of Preoperative Hemotologic Markers on Postoperative Long-term and Short-term Outcomes for Laparoscopic Gastrectomy- A Prospective Cohort Study

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.

Study Overview

• Status: Unknown
• Conditions: Stomach Neoplasms

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who undergoing laparoscopic radical gastrectomy for gastric cancer are included.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
3-year disease overall survival rate	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 day
3-year disease free survival rate		36 months
3-year recurrence pattern		36 months
Time to first ambulation	The data of postoperative recovery course.	10 days
The number of lymph node dissection		1 day
The variation of weight	The variation of weight on postoperative 3, 6, 9 and 12 months	12 months
The daily highest body temperature	The daily highest body temperature before discharge	7 day
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
The amount of abdominal drainage		10 days
Blood transfusion		10 days
The number of positive lymph nodes		1 day
The rate of conversion to laparotomy		1 day
The results of endoscopy	the results of endoscopy on postoperative 3 and 12 months	12 months
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
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
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
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
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
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
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
overall postoperative morbidity rates	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.	30 days
Intraoperative lymph node dissection time	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.	1 days
The variation of cholesterol	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.	12 months
The variation of albumin	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.	12 months
The values of monocyte count	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.	Preoperative 3 days and postoperative 1, 3, and 5 days
The values of platelet count	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.	Preoperative 3 days and postoperative 1, 3, and 5 days

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): October 30, 2017
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 12, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2016YF016-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO