NCT04284943Recruiting
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 23 Feb 2020
- Start date
- 1 Dec 2020
- Primary completion date
- Dec 2027
- Lead sponsor
- Korea University Anam Hospital
- NCT number
- NCT04284943
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Dec 2020 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Use of investigational therapy or participation in any other clinical trial within 3 months
Other illness
- 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
- 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
- Any condition or major illness that, in the investigator's judgement, places the subject at undue risk by participating in the study
Lab values
- Anemia defined as hemoglobin less than 8 in females and 10 in males
Other
- Insulin usage for glycemic control at the time of screening evaluation
- Frail elderly (Rockwood Clinical Frailty Scale ≥5)
- Unable to understand the risks, realistic benefits and compliance requirements of each program
- Geographic inaccessibility
- Pregnancy
Who the study is looking for
- 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%
Age in the registry: 20 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.