Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jul 2015
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 11, 2017
December 1, 2017
2.4 years
February 24, 2016
December 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30-day of postoperative duration
Secondary Outcomes (2)
Change of the postoperative BMI
5-year of postoperative duration.
Change of the postoperative AFA
5-year of postoperative duration
Study Arms (2)
BMI group (Successive patients)
OTHERAll 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.
AFA group(Successive patients)
EXPERIMENTALAll 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jian-Kun Hulead
- West China Hospitalcollaborator
Study Sites (1)
West China Hospital
Chengdu, Sichuan, 610041, China
Related Publications (1)
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.
PMID: 31161593DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian-Kun Hu, M.D.Ph.D.
West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D. Ph.D.
Study Record Dates
First Submitted
February 24, 2016
First Posted
June 15, 2016
Study Start
July 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 11, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share