- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02800005
Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer
December 7, 2017 updated by: Jian-Kun Hu
Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer Patients: a Single Center Prospective Cohort Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dong-Jiao Guo, M.D.
- Email: gdj1337@163.com
Study Contact Backup
- Name: Xin-Zu Chen, M.D.Ph.D.
- Email: chen_xz_wch_scu@126.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital
-
Contact:
- Dong-Jiao Guo, M.D.
- Email: gdj1337@163.com
-
Contact:
- Xin-Zu Chen, MD.PH.D
- Email: chen_xz_wch_scu@126.com
-
Principal Investigator:
- Jian-Kun Hu, M.D.Ph.D.
-
Sub-Investigator:
- Dong-Jiao Guo, M.D.
-
Sub-Investigator:
- Xin-Zu Chen, M.D.Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: BMI group (Successive patients)
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.
|
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.
|
Experimental: AFA group(Successive patients)
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative complications
Time Frame: 30-day of postoperative duration
|
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.
|
30-day of postoperative duration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the postoperative BMI
Time Frame: 5-year of postoperative duration.
|
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.
|
5-year of postoperative duration.
|
Change of the postoperative AFA
Time Frame: 5-year of postoperative duration
|
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.
|
5-year of postoperative duration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jian-Kun Hu, M.D.Ph.D., West China Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
February 24, 2016
First Submitted That Met QC Criteria
June 11, 2016
First Posted (Estimate)
June 15, 2016
Study Record Updates
Last Update Posted (Actual)
December 11, 2017
Last Update Submitted That Met QC Criteria
December 7, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCH-GC-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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