Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery (STARDOM)

Korea University

Status: Enrolling

Conditions: Gastric Cancer; Diabetes Mellitus, Type 2

Treatments: Procedure: Billroth II reconstruction after subtotal gastrectomy; Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomy; Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04284943

STARDOM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Long limb Roux-en-Y reconstruction

Active Comparator group

Description:

Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Treatment:

Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomy

Conventional Roux-en-Y reconstruction

Active Comparator group

Description:

Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Treatment:

Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomy

Billroth II reconstruction

Active Comparator group

Description:

Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer

Treatment:

Procedure: Billroth II reconstruction after subtotal gastrectomy