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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
Korea University Anam Hospital
Seoul, South Korea
RECRUITINGThe success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%
The proportion of subjects with HbA1c \< 6.5% without diabetes medications
Time frame: 12 months
Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%)
The number of days from randomization to the visit date when HgA1c is first observed to be \< 6.5% (or 6.0%) post-randomization
Time frame: Every visit date, assessed up to 12, 24, and 36 months
Success rate of biochemical resolution of diabetes
Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c ≤ 6% (with or without diabetes medication)
Time frame: 12 months, 24 months, 36 months
Success rate of biochemical improvement of diabetes
Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c \<6.5% (with or without diabetes medication)
Time frame: 12 months, 24 months, 36 months
Change in glycated hemoglobin from baseline
percent change
Time frame: 12 months, 24 months, 36 months
Change in fasting plasma glucose level from baseline
percent change
Time frame: 12 months, 24 months, 36 months
Change in total cholesterol
Percent change in total cholesterol at 12 months, 24 months, 36 months
Time frame: 12 months, 24 months, 36 months
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The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)
Change in triglyceride
Percent change in triglyceride at 12 months, 24 months, 36 months
Time frame: 12 months, 24 months, 36 months
Change in High-density Lipoprotein (HDL)
Percent change in high-density lipoprotein (HDL) at 12 months, 24 months, 36 months
Time frame: 12 months, 24 months, 36 months
Change in Low-density Lipoprotein (LDL)
Percent change in Low-density Lipoprotein (LDL) at 12 months, 24 months, 36 months
Time frame: 12 months, 24 months, 36 months
Use of diabetes medication
number of diabetes medication at 12 months, 24 months, 36 months
Time frame: 12 months, 24 months, 36 months
Patients with hypertension and/or requiring antihypertensive therapy
number and percentage
Time frame: 12 months, 24 months, 36 months
Patients with dyslipidemia and/or requiring cholesterol lowering medications
number and percentage
Time frame: 12 months, 24 months, 36 months
Mean and change in weight and BMI from baseline
mean and percent change
Time frame: 12 months, 24 months, 36 months
Mean and change in waist, hip, and thigh circumference from baseline
mean and percent change
Time frame: 12 months, 24 months, 36 months
Change in SF-36 scores of questionnaire from baseline
The MOS 36-Item Short-Form Health Survey
Time frame: 12 months, 24 months, 36 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)
percent change in high-sensitivity C-reactive protein (hs-CRP)
Time frame: 12 months, 24 months, 36 months
Change in Systolic Blood Pressure (SBP)
Change in Systolic Blood Pressure (SBP) at 12 months, 24 months, 36 months
Time frame: 12 months, 24 months, 36 months
The Side Effects and /or Complications of each surgical procedure
number of the Side Effects and /or Complications of each surgical procedure
Time frame: 12 months, 24 months, 36 months
The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%
The proportion of subjects with HbA1c \< 6.5% without diabetes medications
Time frame: 24 months, 36 months