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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Gastric Cancer
• Intervention / Treatment: Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomy; Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomy; Procedure: Billroth II reconstruction after subtotal gastrectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sungsoo Park, MD, PhD; Phone Number: +82 2 920 6772; Email: kugspss@korea.ac.kr
• Study Contact Backup: Name: Yeongkeun Kwon, MD, PhD; Phone Number: +82 2 920 6772; Email: kukwon@korea.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Sungsoo Park, MD, PhD; Phone Number: +82 2 920 6772; Email: kugspss@korea.ac.kr
    • Contact: Yeongkeun Kwon, MD, PhD; Phone Number: +82 2 920 6772; Email: kukwon@korea.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Long limb Roux-en-Y reconstruction; Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.	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).
Active Comparator: Conventional Roux-en-Y reconstruction; Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.	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).
Active Comparator: Billroth II reconstruction; Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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)	12 months, 24 months, 36 months
Change in glycated hemoglobin from baseline	percent change	12 months, 24 months, 36 months
Change in fasting plasma glucose level from baseline	percent change	12 months, 24 months, 36 months
Change in total cholesterol	Percent change in total cholesterol at 12 months, 24 months, 36 months	12 months, 24 months, 36 months
Change in triglyceride	Percent change in triglyceride at 12 months, 24 months, 36 months	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	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	12 months, 24 months, 36 months
Use of diabetes medication	number of diabetes medication at 12 months, 24 months, 36 months	12 months, 24 months, 36 months
Patients with hypertension and/or requiring antihypertensive therapy	number and percentage	12 months, 24 months, 36 months
Patients with dyslipidemia and/or requiring cholesterol lowering medications	number and percentage	12 months, 24 months, 36 months
Mean and change in weight and BMI from baseline	mean and percent change	12 months, 24 months, 36 months
Mean and change in waist, hip, and thigh circumference from baseline	mean and percent change	12 months, 24 months, 36 months
Change in SF-36 scores of questionnaire from baseline	The MOS 36-Item Short-Form Health Survey	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)	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	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	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	24 months, 36 months

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine; Shanghai Jiao Tong University School of Medicine; Guangdong Provincial People's Hospital; The First Hospital of Jilin University; Korea University Ansan Hospital
• Investigators: Principal Investigator: Sungsoo Park, MD, PhD, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 23, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Gastric Cancer; Diabetes Mellitus, Type 2; Subtotal Gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Stomach Neoplasms
• Other Study ID Numbers: STARDOM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No