Back to resultsEffect of Obesity on Surgical Outcomes and Survival for Gastric Cancer
Primary Purpose
Obesity, Gastric Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AFA group (successive patients)
BMI group (successive patients)
Sponsored by
About this trial
This is an interventional screening trial for Obesity focused on measuring gastric cancer, gastrectomy, laparotomy, surgical outcome, survival, abdominal fat area, Body Mass Index
Eligibility Criteria
Inclusion Criteria:
- Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of conventional open total gastrectomy or subtotal gastrectomy;
- Predictively resectable diseases, of preoperative staging Japanese Gastric Cancer Association 14th Edition clinical T1N0M0-T4aN+M0;
- Age：≤75 years, or ≥18 years;
- Without serious disease and malignance disease;
- Without histories of abdominal surgery;
- World Health Organization performance score ≤2, American Society of Anesthesiologists score ≤3;
- No limit to sexual and race;
- Informed consent required;
- Obesity is defined as BMI≧30kg/m2 or preoperative AFA≧100cm2/cm.
Exclusion Criteria:
- Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe chronic obstructive pulmonary disease, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc;
- Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
- Severity mental diseases;
- Primary lesion cannot be resected in the pattern of transabdominal gastrectomy, but for Whipple's procedure, or with a transthoracic approach surgery;
- After signature the Clinical trial agreement, patients and their agent will quit the trial.
Sites / Locations
- West China HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
BMI group (Successive patients)
AFA group(Successive patients)
Arm Description
All successive patients meeting the including criteria and signed the informed consent will be measured BMI and the data will be recorded in the prospective database. The formula for BMI is weight in kilograms divided by height in meters squared (kg/m2). the normal range is usually considered to be 18.5 to 24.9, with less than 18.5 considered underweight, more than 25.0 considered overweight and above 30.0 obese. Investigators declare that there exists no conflicts of interest.
All successive patients meeting the including criteria and signed the informed consent will be measured BMI and the data will be recorded in the prospective database. The abdominal fat area at the umbilical level was measured using a CT scanner(sango Mount Monitor Wireless Panel; Siemens , Munich, Germany) while the examinee was in a supine position and estimated using a Volume software (fat Pointer; Siemens , Munich, Germany). The imaging conditions were 120 kilovolt and 50 milliampere, using a 5-mm-thick slice.The areas covered by visceral fat software calculated from pixels with densities ranging from-190 to -30 hounsfield unit. No contrast agent is needed. Patients in the AFA group will be also measured by BMI. Investigators declare that there exists no conflicts of interest.
Outcomes
Primary Outcome Measures
postoperative complications
The criteria of postoperative complications in the BMI group and AFA group both adopt the definition of The clavian-dildo classification of surgical complications: five-year experience. Ann Surg. 2009;250 (2):187-96.Postoperative complications in Grade 1 were classified as minor complications, while complications in Grade 2 to 5 were classified as major complications.
Secondary Outcome Measures
Change of the postoperative BMI
The body weight(kilograms) and height(meters) change of all enrollment after 5-year postoperative duration were measured to get the change of BMI.The formula for BMI is weight in kilograms divided by height in meters squared (kg/m2). The change of BMI was compared between preoperation and 5-year postoperative duration.
Change of the postoperative AFA
AFA of all enrollment after 5-year postoperative duration were measured by CT. The AFA at the umbilical level was measured using a CT scanner (sango Mount Monitor Wireless Panel; Siemens , Munich, Germany) while the examinee was in a supine position and estimated using a Volume software (fat Pointer; Siemens , Munich, Germany). The imaging conditions were 120 kilovolt and 50 milliampere, using a 5-mm-thick slice. The areas covered by visceral fat software calculated from pixels with densities ranging from-190 to -30 hounsfield unit. The change of AFA was compared between preoperation and 5-year postoperative duration.
Full Information
NCT ID
NCT02800005
First Posted
February 24, 2016
Last Updated
December 7, 2017
Sponsor
Jian-Kun Hu
Collaborators
West China Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02800005
Brief Title
Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer
Official Title
Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer Patients: a Single Center Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jian-Kun Hu
Collaborators
West China Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
As the number of obesity continues to increase, surgical oncologist pay more attention to the effect of obesity on surgical outcomes and survival of digestive systemin cancers. Body mass index(BMI) is one of the most widely used measurements of obesity. Abdominal fat area (AFA) calculated by computed tomography is popular because of its validity of fat distribution. There is still no consensus which of BMI and AFA could be the more effective measurement and more accurate to evaluate effect of obesity on surgical outcomes and survival. Gastric cancer is one of the most common digestive system cancers, and gastrectomy is the primary therapeutic options.It is important to compare the different measurements(BMI or AFA) to assess obesity and effect on surgical outcome and survival for gastric cancer patients.
Detailed Description
Standard operation procedure（SOP）
Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
Procedures: The surgical treatments is adopted total or subtotal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3.
Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
Follow-up: Follow-up will last to 5-year of the postoperative period. The postoperative complications is graded by the clavian-dildo classification. The postoperative complications and quality of life (change of AFA,performance status, recurrence and overall survival)are the focus of this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Gastric Cancer
Keywords
gastric cancer, gastrectomy, laparotomy, surgical outcome, survival, abdominal fat area, Body Mass Index
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BMI group (Successive patients)
Arm Type
Other
Arm Description
All successive patients meeting the including criteria and signed the informed consent will be measured BMI and the data will be recorded in the prospective database. The formula for BMI is weight in kilograms divided by height in meters squared (kg/m2). the normal range is usually considered to be 18.5 to 24.9, with less than 18.5 considered underweight, more than 25.0 considered overweight and above 30.0 obese. Investigators declare that there exists no conflicts of interest.
Arm Title
AFA group(Successive patients)
Arm Type
Experimental
Arm Description
All successive patients meeting the including criteria and signed the informed consent will be measured BMI and the data will be recorded in the prospective database. The abdominal fat area at the umbilical level was measured using a CT scanner(sango Mount Monitor Wireless Panel; Siemens , Munich, Germany) while the examinee was in a supine position and estimated using a Volume software (fat Pointer; Siemens , Munich, Germany). The imaging conditions were 120 kilovolt and 50 milliampere, using a 5-mm-thick slice.The areas covered by visceral fat software calculated from pixels with densities ranging from-190 to -30 hounsfield unit. No contrast agent is needed. Patients in the AFA group will be also measured by BMI. Investigators declare that there exists no conflicts of interest.
Intervention Type
Device
Intervention Name(s)
AFA group (successive patients)
Intervention Description
The abdominal fat area at the umbilical level was measured using a CT scanner(sango Mount Monitor Wireless Panel; Siemens , Munich, Germany) while the examinee was in a supine position and estimated using a Volume software (fat Pointer; Siemens , Munich, Germany). The imaging conditions were 120 kilovolt and 50 milliampere, using a 5-mm-thick slice.The areas covered by visceral fat software calculated from pixels with densities ranging from-190 to -30 hounsfield unit . No contrast agent is needed.
Intervention Type
Other
Intervention Name(s)
BMI group (successive patients)
Intervention Description
The formula for BMI is weight in kilograms divided by height in meters squared (kg/m2). the normal range is usually considered to be 18.5 to 24.9, with less than 18.5 considered underweight, more than 25.0 considered overweight and above 30.0 obese.
Primary Outcome Measure Information:
Title
postoperative complications
Description
The criteria of postoperative complications in the BMI group and AFA group both adopt the definition of The clavian-dildo classification of surgical complications: five-year experience. Ann Surg. 2009;250 (2):187-96.Postoperative complications in Grade 1 were classified as minor complications, while complications in Grade 2 to 5 were classified as major complications.
Time Frame
30-day of postoperative duration
Secondary Outcome Measure Information:
Title
Change of the postoperative BMI
Description
The body weight(kilograms) and height(meters) change of all enrollment after 5-year postoperative duration were measured to get the change of BMI.The formula for BMI is weight in kilograms divided by height in meters squared (kg/m2). The change of BMI was compared between preoperation and 5-year postoperative duration.
Time Frame
5-year of postoperative duration.
Title
Change of the postoperative AFA
Description
AFA of all enrollment after 5-year postoperative duration were measured by CT. The AFA at the umbilical level was measured using a CT scanner (sango Mount Monitor Wireless Panel; Siemens , Munich, Germany) while the examinee was in a supine position and estimated using a Volume software (fat Pointer; Siemens , Munich, Germany). The imaging conditions were 120 kilovolt and 50 milliampere, using a 5-mm-thick slice. The areas covered by visceral fat software calculated from pixels with densities ranging from-190 to -30 hounsfield unit. The change of AFA was compared between preoperation and 5-year postoperative duration.
Time Frame
5-year of postoperative duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of conventional open total gastrectomy or subtotal gastrectomy;
Predictively resectable diseases, of preoperative staging Japanese Gastric Cancer Association 14th Edition clinical T1N0M0-T4aN+M0;
Age：≤75 years, or ≥18 years;
Without serious disease and malignance disease;
Without histories of abdominal surgery;
World Health Organization performance score ≤2, American Society of Anesthesiologists score ≤3;
No limit to sexual and race;
Informed consent required;
Obesity is defined as BMI≧30kg/m2 or preoperative AFA≧100cm2/cm.
Exclusion Criteria:
Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe chronic obstructive pulmonary disease, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc;
Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
Severity mental diseases;
Primary lesion cannot be resected in the pattern of transabdominal gastrectomy, but for Whipple's procedure, or with a transthoracic approach surgery;
After signature the Clinical trial agreement, patients and their agent will quit the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Jiao Guo, M.D.
Email
gdj1337@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin-Zu Chen, M.D.Ph.D.
Email
chen_xz_wch_scu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-Kun Hu, M.D.Ph.D.
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Jiao Guo, M.D.
Email
gdj1337@163.com
First Name & Middle Initial & Last Name & Degree
Xin-Zu Chen, MD.PH.D
Email
chen_xz_wch_scu@126.com
First Name & Middle Initial & Last Name & Degree
Jian-Kun Hu, M.D.Ph.D.
First Name & Middle Initial & Last Name & Degree
Dong-Jiao Guo, M.D.
First Name & Middle Initial & Last Name & Degree
Xin-Zu Chen, M.D.Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31161593
Citation
Yang SJ, Li HR, Zhang WH, Liu K, Zhang DY, Sun LF, Chen XL, Zhao LY, Chen XZ, Yang K, Chen ZX, Zhou ZG, Hu JK. Visceral Fat Area (VFA) Superior to BMI for Predicting Postoperative Complications After Radical Gastrectomy: a Prospective Cohort Study. J Gastrointest Surg. 2020 Jun;24(6):1298-1306. doi: 10.1007/s11605-019-04259-0. Epub 2019 Jun 3.
Results Reference
derived
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Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer
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