Clinical trial NCT04284943: Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Diabetes Mellitus, Type 2
Keywords: Gastric Cancer
Diabetes Mellitus, Type 2
Subtotal Gastrectomy
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: The First Hospital of Jilin University
name: Shanghai Jiao Tong University School of Medicine
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Korea University Ansan Hospital
First posted: 2020-02-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%
timeFrame: 12 months
Secondary outcomes:
measure: Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%)
timeFrame: Every visit date, assessed up to 12, 24, and 36 months
measure: Success rate of biochemical resolution of diabetes
timeFrame: 12 months, 24 months, 36 months
measure: Success rate of biochemical improvement of diabetes
timeFrame: 12 months, 24 months, 36 months
measure: Change in glycated hemoglobin from baseline
timeFrame: 12 months, 24 months, 36 months
measure: Change in fasting plasma glucose level from baseline
timeFrame: 12 months, 24 months, 36 months
measure: Change in total cholesterol
timeFrame: 12 months, 24 months, 36 months
measure: Change in triglyceride
timeFrame: 12 months, 24 months, 36 months
measure: Change in High-density Lipoprotein (HDL)
timeFrame: 12 months, 24 months, 36 months
measure: Change in Low-density Lipoprotein (LDL)
timeFrame: 12 months, 24 months, 36 months
measure: Use of diabetes medication
timeFrame: 12 months, 24 months, 36 months
measure: Patients with hypertension and/or requiring antihypertensive therapy
timeFrame: 12 months, 24 months, 36 months
measure: Patients with dyslipidemia and/or requiring cholesterol lowering medications
timeFrame: 12 months, 24 months, 36 months
measure: Mean and change in weight and BMI from baseline
timeFrame: 12 months, 24 months, 36 months
measure: Mean and change in waist, hip, and thigh circumference from baseline
timeFrame: 12 months, 24 months, 36 months
measure: Change in SF-36 scores of questionnaire from baseline
timeFrame: 12 months, 24 months, 36 months
measure: Change in High-sensitivity C-reactive Protein (Hs-CRP)
timeFrame: 12 months, 24 months, 36 months
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: 12 months, 24 months, 36 months
measure: The Side Effects and /or Complications of each surgical procedure
timeFrame: 12 months, 24 months, 36 months
measure: The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%
timeFrame: 24 months, 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Sungsoo Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: