Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery (STARDOM)
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- STATUS
- Recruiting
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- End date
- Dec 29, 2023
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- participants needed
- 120
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- sponsor
- Korea University Anam Hospital
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 Identifier | NCT04284943 |
| Sponsor | Korea University Anam Hospital |
| Last Modified on | 29 July 2023 |
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