Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

Diabetes Mellitus, Type 2 Clinical Trial

— STARDOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04284943
• Other study ID #: STARDOM
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Korea University Anam Hospital
• Contact: Sungsoo Park, MD, PhD
• Phone: +82 2 920 6772
• Email: kugspss[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Gastric Cancer
• Stomach Neoplasms

Intervention

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).
• 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).
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong Provincial People's Hospital, Korea University Ansan Hospital, Shanghai Jiao Tong University School of Medicine, The First Hospital of Jilin University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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