Recruiting
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
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.
ClinicalTrials.gov IDNCT04284943
PhaseNA
Enrollment120
SponsorKorea University Anam Hospital
Age20 Years
SexALL
Conditions studied
Gastric Cancer, Diabetes Mellitus, Type 2
About this study
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.
Interventions
- Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomy — The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
- Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomy — The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
- Procedure: Billroth II reconstruction after subtotal gastrectomy — The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)
Primary outcomes
- The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5% (12 months)
Eligibility information
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 diagnosed with early or stage I cancer than have been successfully treated are eligible per investigator discretion
* Frail elderly (Rockwood Clinical Frailty Scale ≥5)
* Any condition or major illness that, in the investigator's judgement, places the subject at undue risk by participating in the study
* Unable to understand the risks, realistic benefits and compliance requirements of each program
* Use of investigational therapy or participation in any other clinical trial within 3 months
* Geographic inaccessibility
* Pregnancy
Study locations
- Korea University Anam Hospital, Seoul, 02841 South Korea
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.