Comparing surgical methods for treating obesity-related diseases in gastric cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Korea University Anam Hospital
  Seoul, South Korea 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.