Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-69
SponsorKorea University Anam Hospital
About this trial
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
Qualifiers
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%
Disqualifiers
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
Trial design
Treatments tested in this trial
- Long limb Roux-en-Y reconstruction after subtotal gastrectomy
- Conventional Roux-en-Y reconstruction after subtotal gastrectomy
- Billroth II reconstruction after subtotal gastrectomy
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Korea University Anam Hospital
Lead sponsor
Korea University Ansan Hospital
Collaborator
Korea University Guro Hospital
Collaborator
Chonnam National University Hospital
Collaborator
Kyung Hee University Hospital at Gangdong
Collaborator
Ajou University
Collaborator
Source ClinicalTrials.gov