Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

Not Applicable

Recruiting

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

• Registration Number: NCT04284943
• Lead Sponsor: Korea University Anam Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2020-02-23
• Study First Posted: 2020-02-26
• Study Start: 2020-12-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Roux-en-Y reconstruction	Conventional Roux-en-Y reconstruction after subtotal gastrectomy	Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.
Long limb Roux-en-Y reconstruction	Long limb Roux-en-Y reconstruction after subtotal gastrectomy	Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.
Billroth II reconstruction	Billroth II reconstruction after subtotal gastrectomy	Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer

Primary Outcome Measures

Name	Time	Method
The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%	12 months	The proportion of subjects with HbA1c \< 6.5% without diabetes medications

Secondary Outcome Measures

Name	Time	Method
Change in glycated hemoglobin from baseline	12 months, 24 months, 36 months	percent change
Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%)	Every visit date, assessed up to 12, 24, and 36 months	The number of days from randomization to the visit date when HgA1c is first observed to be \< 6.5% (or 6.0%) post-randomization
Success rate of biochemical resolution of diabetes	12 months, 24 months, 36 months	Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c ≤ 6% (with or without diabetes medication)
Success rate of biochemical improvement of diabetes	12 months, 24 months, 36 months	Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c \<6.5% (with or without diabetes medication)
Change in fasting plasma glucose level from baseline	12 months, 24 months, 36 months	percent change
Change in triglyceride	12 months, 24 months, 36 months	Percent change in triglyceride at 12 months, 24 months, 36 months
Change in High-density Lipoprotein (HDL)	12 months, 24 months, 36 months	Percent change in high-density lipoprotein (HDL) at 12 months, 24 months, 36 months
Change in Low-density Lipoprotein (LDL)	12 months, 24 months, 36 months	Percent change in Low-density Lipoprotein (LDL) at 12 months, 24 months, 36 months
Change in total cholesterol	12 months, 24 months, 36 months	Percent change in total cholesterol at 12 months, 24 months, 36 months
Use of diabetes medication	12 months, 24 months, 36 months	number of diabetes medication at 12 months, 24 months, 36 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)	12 months, 24 months, 36 months	percent change in high-sensitivity C-reactive protein (hs-CRP)
Patients with hypertension and/or requiring antihypertensive therapy	12 months, 24 months, 36 months	number and percentage
Patients with dyslipidemia and/or requiring cholesterol lowering medications	12 months, 24 months, 36 months	number and percentage
Mean and change in weight and BMI from baseline	12 months, 24 months, 36 months	mean and percent change
Mean and change in waist, hip, and thigh circumference from baseline	12 months, 24 months, 36 months	mean and percent change
Change in SF-36 scores of questionnaire from baseline	12 months, 24 months, 36 months	The MOS 36-Item Short-Form Health Survey
Change in Systolic Blood Pressure (SBP)	12 months, 24 months, 36 months	Change in Systolic Blood Pressure (SBP) at 12 months, 24 months, 36 months
The Side Effects and /or Complications of each surgical procedure	12 months, 24 months, 36 months	number of the Side Effects and /or Complications of each surgical procedure
The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%	24 months, 36 months	The proportion of subjects with HbA1c \< 6.5% without diabetes medications

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of