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

Primary Purpose

Gastric Cancer, Diabetes Mellitus, Type 2

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Long limb Roux-en-Y reconstruction after subtotal gastrectomy

Conventional Roux-en-Y reconstruction after subtotal gastrectomy

Billroth II reconstruction after subtotal gastrectomy

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Diabetes Mellitus, Type 2, Subtotal Gastrectomy

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Long limb Roux-en-Y reconstruction

Conventional Roux-en-Y reconstruction

Billroth II reconstruction

Arm Description

Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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)

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)

Change in glycated hemoglobin from baseline

percent change

Change in fasting plasma glucose level from baseline

percent change

Change in total cholesterol

Percent change in total cholesterol at 12 months, 24 months, 36 months

Change in triglyceride

Percent change in triglyceride at 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

Change in Low-density Lipoprotein (LDL)

Percent change in Low-density Lipoprotein (LDL) at 12 months, 24 months, 36 months

Use of diabetes medication

number of diabetes medication at 12 months, 24 months, 36 months

Patients with hypertension and/or requiring antihypertensive therapy

number and percentage

Patients with dyslipidemia and/or requiring cholesterol lowering medications

number and percentage

Mean and change in weight and BMI from baseline

mean and percent change

Mean and change in waist, hip, and thigh circumference from baseline

mean and percent change

Change in SF-36 scores of questionnaire from baseline

The MOS 36-Item Short-Form Health Survey

Change in High-sensitivity C-reactive Protein (Hs-CRP)

percent change in high-sensitivity C-reactive protein (hs-CRP)

Change in Systolic Blood Pressure (SBP)

Change in Systolic Blood Pressure (SBP) at 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

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

Full Information

NCT ID

NCT04284943

First Posted

February 23, 2020

Last Updated

July 3, 2023

Sponsor

Korea University Anam Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04284943

Brief Title

Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Korea University Anam Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Diabetes Mellitus, Type 2

Keywords

Gastric Cancer, Diabetes Mellitus, Type 2, Subtotal Gastrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Long limb Roux-en-Y reconstruction

Arm Type

Active Comparator

Arm Description

Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Arm Title

Conventional Roux-en-Y reconstruction

Arm Type

Active Comparator

Arm Description

Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Arm Title

Billroth II reconstruction

Arm Type

Active Comparator

Arm Description

Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer

Intervention Type

Procedure

Intervention Name(s)

Long limb Roux-en-Y reconstruction after subtotal gastrectomy

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Conventional Roux-en-Y reconstruction after subtotal gastrectomy

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Billroth II reconstruction after subtotal gastrectomy

Intervention Description

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)

Primary Outcome Measure Information:

Title

The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%

Description

The proportion of subjects with HbA1c < 6.5% without diabetes medications

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%)

Description

The number of days from randomization to the visit date when HgA1c is first observed to be < 6.5% (or 6.0%) post-randomization

Time Frame

Every visit date, assessed up to 12, 24, and 36 months

Title

Success rate of biochemical resolution of diabetes

Description

Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c ≤ 6% (with or without diabetes medication)

Time Frame