Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

Official title

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

Overview

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.

Interventions

• Procedure Long limb Roux-en-Y reconstruction after subtotal gastrectomy
  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).
• Procedure Conventional Roux-en-Y reconstruction after subtotal gastrectomy
  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).
• Procedure Billroth II reconstruction after subtotal gastrectomy
  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)

Primary outcome measures

• The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5% [Time frame: 12 months]

Secondary outcome measures (12)

• Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%) [Time frame: Every visit date, assessed up to 12, 24, and 36 months]
• Success rate of biochemical resolution of diabetes [Time frame: 12 months, 24 months, 36 months]
• Success rate of biochemical improvement of diabetes [Time frame: 12 months, 24 months, 36 months]
• Change in glycated hemoglobin from baseline [Time frame: 12 months, 24 months, 36 months]
• Change in fasting plasma glucose level from baseline [Time frame: 12 months, 24 months, 36 months]
• Change in total cholesterol [Time frame: 12 months, 24 months, 36 months]
• Change in triglyceride [Time frame: 12 months, 24 months, 36 months]
• Change in High-density Lipoprotein (HDL) [Time frame: 12 months, 24 months, 36 months]
• Change in Low-density Lipoprotein (LDL) [Time frame: 12 months, 24 months, 36 months]
• Use of diabetes medication [Time frame: 12 months, 24 months, 36 months]
• Patients with hypertension and/or requiring antihypertensive therapy [Time frame: 12 months, 24 months, 36 months]
• Patients with dyslipidemia and/or requiring cholesterol lowering medications [Time frame: 12 months, 24 months, 36 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Korea University Anam Hospital — Seoul

Identifiers

NCT: NCT04284943 · STARDOM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗