NCT04284943 Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
| NCT ID | NCT04284943 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Korea University Anam Hospital |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2020-12-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Sungsoo Park, MD, PhD
PRINCIPAL INVESTIGATOR
Korea University Anam Hospital
Frequently Asked Questions
Who can join the NCT04284943 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 69 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04284943 currently recruiting?
Yes, NCT04284943 is actively recruiting participants. Contact the research team at kugspss@korea.ac.kr for enrollment information.
Where is the NCT04284943 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT04284943 clinical trial?
NCT04284943 is sponsored by Korea University Anam Hospital. The principal investigator is Sungsoo Park, MD, PhD at Korea University Anam Hospital. The trial plans to enroll 120 participants.
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