Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery (NCT04284943) | Clinical Trial Compass
UnknownNot Applicable
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
South Korea120 participantsStarted 2020-12-01
Plain-language summary
This is a prospective, multi-center, randomized controlled trial to compare Billroth II reconstruction versus conventional Roux-en-Y reconstruction versus long limb Roux-en-Y reconstruction for glycemic control in patients with concurrent type 2 diabetes and gastric cancer.
Who can participate
Age range20 Years – 69 Years
SexALL
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Inclusion Criteria:
* Distal gastric adenocarcinoma diagnosed pathologically under preoperative endoscopic biopsy, and clinical stage I-II
* Body mass index ≥ 23 kg/m2
* Type 2 diabetes and HbA1c ≥ 6.5%
Exclusion Criteria:
* Insulin usage for glycemic control at the time of screening evaluation
* Prior gastrointestinal surgery including splenectomy, hepatobiliary and pancreatic surgery (except hemorrhoidectomy, herniorrhaphy, and appendectomy)
* Abdominal, thoracic, pelvic and/or obstetric-gynecologic surgery within 3 months
* Cardiovascular conditions including significant known CAD, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension. Subjects with CAD that have been successfully treated with CABG or PCI, and have no evidence of active ischemia are eligible
* Kidney disease including renovascular hypertension, renal artery stenosis, or end-stage renal disease
* Chronic liver disease including liver cirrhosis, alpha-1 antitrypsin deficiency
* Gastrointestinal disorders including inflammatory bowel disease (Crohn's disease or ulcerative colitis) or any malabsorptive disorders
* Psychiatric disorders including dementia, active psychosis, history of suicide attempts, alcohol or drug abuse within 12 months
* Severe pulmonary disease defined as FEV1 \<50% of predicted value
* Anemia defined as hemoglobin less than 8 in females and 10 in males
* Malignancy within 5 years (except squamous cell and basal cell cancer of the skin). Subjects diagn…
What they're measuring
1
The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%