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

August 4, 2026 updated by: Sungsoo Park, Korea University Anam Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Korea
      • Seoul, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 65 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%
Time Frame: 12 months
The proportion of subjects with HbA1c < 6.5% without diabetes medications
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%)
Time Frame: 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
Every visit date, assessed up to 12, 24, and 36 months
Success rate of biochemical resolution of diabetes
Time Frame: 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)
12 months, 24 months, 36 months
Success rate of biochemical improvement of diabetes
Time Frame: 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)
12 months, 24 months, 36 months
Change in glycated hemoglobin from baseline
Time Frame: 12 months, 24 months, 36 months
percent change
12 months, 24 months, 36 months
Change in fasting plasma glucose level from baseline
Time Frame: 12 months, 24 months, 36 months
percent change
12 months, 24 months, 36 months
Change in total cholesterol
Time Frame: 12 months, 24 months, 36 months
Percent change in total cholesterol at 12 months, 24 months, 36 months
12 months, 24 months, 36 months
Change in triglyceride
Time Frame: 12 months, 24 months, 36 months
Percent change in triglyceride at 12 months, 24 months, 36 months
12 months, 24 months, 36 months
Change in High-density Lipoprotein (HDL)
Time Frame: 12 months, 24 months, 36 months
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)
Time Frame: 12 months, 24 months, 36 months
Percent change in Low-density Lipoprotein (LDL) at 12 months, 24 months, 36 months
12 months, 24 months, 36 months
Use of diabetes medication
Time Frame: 12 months, 24 months, 36 months
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
Time Frame: 12 months, 24 months, 36 months
number and percentage
12 months, 24 months, 36 months
Patients with dyslipidemia and/or requiring cholesterol lowering medications
Time Frame: 12 months, 24 months, 36 months
number and percentage
12 months, 24 months, 36 months
Mean and change in weight and BMI from baseline
Time Frame: 12 months, 24 months, 36 months
mean and percent change
12 months, 24 months, 36 months
Mean and change in waist, hip, and thigh circumference from baseline
Time Frame: 12 months, 24 months, 36 months
mean and percent change
12 months, 24 months, 36 months
Change in SF-36 scores of questionnaire from baseline
Time Frame: 12 months, 24 months, 36 months
The MOS 36-Item Short-Form Health Survey
12 months, 24 months, 36 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Time Frame: 12 months, 24 months, 36 months
percent change in high-sensitivity C-reactive protein (hs-CRP)
12 months, 24 months, 36 months
Change in Systolic Blood Pressure (SBP)
Time Frame: 12 months, 24 months, 36 months
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
Time Frame: 12 months, 24 months, 36 months
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%
Time Frame: 24 months, 36 months
The proportion of subjects with HbA1c < 6.5% without diabetes medications
24 months, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea University Anam Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chonnam National University Hospital
Korea University Guro Hospital
Kyung Hee University Hospital at Gangdong
Korea University Ansan Hospital
Ajou University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sungsoo Park, MD, PhD, Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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