Comparing surgical methods for treating obesity-related diseases in gastric cancer patients
A Randomized Controlled Trial Comparing 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
This study is testing which of three different surgical methods can help gastric cancer patients with type 2 diabetes improve their blood sugar control and overall health after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 69 Years |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04284943 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, multi-center, randomized controlled trial aimed at comparing three surgical reconstruction techniques—Billroth II, conventional Roux-en-Y, and long limb Roux-en-Y—following subtotal gastrectomy in patients with concurrent type 2 diabetes and gastric cancer. The study seeks to evaluate the effectiveness of these procedures on glycemic control and metabolic outcomes. By controlling for confounding factors related to cancer and treatment regimens, the trial aims to provide clearer insights into which surgical approach may offer the best benefits for patients. The findings could help refine surgical strategies for managing obesity-related diseases in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with distal gastric adenocarcinoma at clinical stages I-II, who also have a body mass index of 23 kg/m2 or higher and type 2 diabetes with an HbA1c of 6.5% or greater.
Not a fit: Patients who are using insulin for glycemic control or have a history of significant cardiovascular or chronic liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and better overall outcomes for patients with gastric cancer and type 2 diabetes.
How similar studies have performed: Previous studies have shown varying success with different surgical approaches for metabolic effects, but this specific comparison of Billroth II and Roux-en-Y techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Korea University Anam Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Sungsoo Park, MD, PhD — Korea University Anam Hospital
- Study coordinator: Sungsoo Park, MD, PhD
- Email: kugspss@korea.ac.kr
- Phone: +82 2 920 6772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.