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Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800005
Recruitment Status : Unknown
Verified December 2017 by Jian-Kun Hu, West China Hospital.
Recruitment status was:  Recruiting
First Posted : June 15, 2016
Last Update Posted : December 11, 2017
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Jian-Kun Hu, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity Gastric Cancer Device: AFA group (successive patients) Other: BMI group (successive patients) Not Applicable

Detailed Description:

Standard operation procedure(SOP)

  1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
  2. Procedures: The surgical treatments is adopted total or subtotal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3.
  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.
  4. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer Patients: a Single Center Prospective Cohort Study
Study Start Date : July 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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.
Other: BMI group (successive patients)
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.
Device: AFA group (successive patients)
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.

Other: BMI group (successive patients)
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of conventional open total gastrectomy or subtotal gastrectomy;
  2. Predictively resectable diseases, of preoperative staging Japanese Gastric Cancer Association 14th Edition clinical T1N0M0-T4aN+M0;
  3. Age:≤75 years, or ≥18 years;
  4. Without serious disease and malignance disease;
  5. Without histories of abdominal surgery;
  6. World Health Organization performance score ≤2, American Society of Anesthesiologists score ≤3;
  7. No limit to sexual and race;
  8. Informed consent required;
  9. Obesity is defined as BMI≧30kg/m2 or preoperative AFA≧100cm2/cm.

Exclusion Criteria:

  1. 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;
  2. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
  3. Severity mental diseases;
  4. Primary lesion cannot be resected in the pattern of transabdominal gastrectomy, but for Whipple's procedure, or with a transthoracic approach surgery;
  5. After signature the Clinical trial agreement, patients and their agent will quit the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800005


Contacts
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Contact: Dong-Jiao Guo, M.D. gdj1337@163.com
Contact: Xin-Zu Chen, M.D.Ph.D. chen_xz_wch_scu@126.com

Locations
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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Dong-Jiao Guo, M.D.       gdj1337@163.com   
Contact: Xin-Zu Chen, MD.PH.D       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.         
Sponsors and Collaborators
Jian-Kun Hu
West China Hospital
Investigators
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Principal Investigator: Jian-Kun Hu, M.D.Ph.D. West China Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jian-Kun Hu, M.D. Ph.D., West China Hospital
ClinicalTrials.gov Identifier: NCT02800005    
Other Study ID Numbers: WCH-GC-04
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jian-Kun Hu, West China Hospital:
gastric cancer
gastrectomy
laparotomy
surgical outcome
survival
abdominal fat area
Body Mass Index
Additional relevant MeSH terms:
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Stomach Neoplasms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases