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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%
Study Overview
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.
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 Billroth II and Roux-en-Y procedure involve the creation of duodenal switch which is thought to be responsible for metabolic effects by altering enteric hormones. Accordingly, several retrospective studies reported that Billroth I reconstruction has less effect on diabetes compared to Billroth II and Roux-en-Y reconstruction. While little is known about different effects of Billroth II and Roux-en-Y procedure, a study retrospectively show that Roux-en-Y procedure has significantly higher rate of T2DM remission than Billroth II procedure. Investigators conduct a randomized controlled trial to control possible confounders arising from diverse metabolic effects of cancer and minimize differences in treatment regimen among patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Long limb Roux-en-Y reconstruction
Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.
Intervention: Long limb Roux-en-Y reconstruction after subtotal gastrectomy (Procedure)
Conventional Roux-en-Y reconstruction
Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.
Intervention: Conventional Roux-en-Y reconstruction after subtotal gastrectomy (Procedure)
Billroth II reconstruction
Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer
Intervention: Billroth II reconstruction after subtotal gastrectomy (Procedure)
Outcomes
Primary Outcomes
The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%
Time Frame: 12 months
The proportion of subjects with HbA1c \< 6.5% without diabetes medications
Secondary Outcomes
- Change in glycated hemoglobin from baseline(12 months, 24 months, 36 months)
- Change in High-sensitivity C-reactive Protein (Hs-CRP)(12 months, 24 months, 36 months)
- Mean and change in weight and BMI from baseline(12 months, 24 months, 36 months)
- Mean and change in waist, hip, and thigh circumference from baseline(12 months, 24 months, 36 months)
- Change in SF-36 scores of questionnaire from baseline(12 months, 24 months, 36 months)
- Change in total cholesterol(12 months, 24 months, 36 months)
- Use of diabetes medication(12 months, 24 months, 36 months)
- Success rate of biochemical resolution of diabetes(12 months, 24 months, 36 months)
- Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%)(Every visit date, assessed up to 12, 24, and 36 months)
- Success rate of biochemical improvement of diabetes(12 months, 24 months, 36 months)
- Change in fasting plasma glucose level from baseline(12 months, 24 months, 36 months)
- Change in triglyceride(12 months, 24 months, 36 months)
- Change in High-density Lipoprotein (HDL)(12 months, 24 months, 36 months)
- Change in Low-density Lipoprotein (LDL)(12 months, 24 months, 36 months)
- Patients with hypertension and/or requiring antihypertensive therapy(12 months, 24 months, 36 months)
- Patients with dyslipidemia and/or requiring cholesterol lowering medications(12 months, 24 months, 36 months)
- Change in Systolic Blood Pressure (SBP)(12 months, 24 months, 36 months)
- The Side Effects and /or Complications of each surgical procedure(12 months, 24 months, 36 months)
- The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%(24 months, 36 months)
Investigators
Sungsoo Park
Professor
Korea University Anam Hospital