Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer (NCT02800005) | Clinical Trial Compass
UnknownNot Applicable
Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer
China600 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.