Status:
UNKNOWN
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
Lead Sponsor:
Korea University Anam Hospital
Collaborating Sponsors:
Guangdong Provincial People's Hospital
The First Hospital of Jilin University
Conditions:
Gastric Cancer
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-69 years
Phase:
NA
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 glycem...
Detailed Description
Billroth I, Billroth II, or Roux-en-Y procedure follows gastrectomy to reconstruct the gastrointestinal tract. Billroth I procedure restores the normal configuration of the gastrointestinal tract and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04284943
Start Date
December 1 2020
End Date
December 1 2023
Last Update
July 5 2023
Active Locations (1)
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1
Korea University Anam Hospital
Seoul, South Korea, 02841