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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2023
  • participants needed
    120
  • sponsor
    Korea University Anam Hospital
Updated on 26 April 2022
diabetes
gastrectomy
body mass index
cancer
gastric adenocarcinoma
adenocarcinoma
bariatric surgery
endoscopic biopsy

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.

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.

Details
Condition Gastric Cancer, Diabetes Mellitus, Type 2
Treatment Long limb Roux-en-Y reconstruction after subtotal gastrectomy, Conventional Roux-en-Y reconstruction after subtotal gastrectomy, Billroth II reconstruction after subtotal gastrectomy
Clinical Study IdentifierNCT04284943
SponsorKorea University Anam Hospital
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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
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