Gastric CancerSTARDOMNCT04284943
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
A study testing Long limb Roux-en-Y reconstruction after subtotal gastrectomy, Conventional Roux-en-Y reconstruction after subtotal gastrectomy and Billroth II reconstruction after subtotal gastrectomy in people with Gastric Cancer and Diabetes Mellitus, Type 2, run by Korea University Anam Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Gastric Cancer, Diabetes Mellitus, Type 2
- What is being tested?
- Long limb Roux-en-Y reconstruction after subtotal gastrectomy, Conventional Roux-en-Y reconstruction after subtotal gastrectomy and Billroth II reconstruction after subtotal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2020to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Sungsoo Park, MD, PhD, +82 2 920 6772, kugspss@korea.ac.kr
Yeongkeun Kwon, MD, PhD, +82 2 920 6772, kukwon@korea.ac.kr
About this study
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
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.
Read the 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.
- Conditions
- Gastric Cancer, Diabetes Mellitus, Type 2
- Being tested
- Long limb Roux-en-Y reconstruction after subtotal gastrectomy, Conventional Roux-en-Y reconstruction after subtotal gastrectomy, Billroth II reconstruction after subtotal gastrectomy
- Keywords
- Gastric Cancer, Diabetes Mellitus, Type 2, Subtotal Gastrectomy
- Medical subject headings
- Stomach Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long limb Roux-en-Y reconstruction after subtotal gastrectomyProcedure or surgery
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 gastrectomyProcedure or surgery
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 gastrectomyProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Long limb Roux-en-Y reconstruction | Active comparator | Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer. Receives: Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomy |
| Conventional Roux-en-Y reconstruction | Active comparator | Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer. Receives: Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomy |
| Billroth II reconstruction | Active comparator | Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer Receives: Procedure: Billroth II reconstruction after subtotal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (19)
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
Measured: Every visit date, assessed up to 12, 24, and 36 months
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)
Measured: 12 months, 24 months, 36 months
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)
Measured: 12 months, 24 months, 36 months
Change in glycated hemoglobin from baseline
percent change
Measured: 12 months, 24 months, 36 months
Change in fasting plasma glucose level from baseline
percent change
Measured: 12 months, 24 months, 36 months
Change in total cholesterol
Percent change in total cholesterol at 12 months, 24 months, 36 months
Measured: 12 months, 24 months, 36 months
Change in triglyceride
Percent change in triglyceride at 12 months, 24 months, 36 months
Measured: 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
Measured: 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
Measured: 12 months, 24 months, 36 months
Use of diabetes medication
number of diabetes medication at 12 months, 24 months, 36 months
Measured: 12 months, 24 months, 36 months
Patients with hypertension and/or requiring antihypertensive therapy
number and percentage
Measured: 12 months, 24 months, 36 months
Patients with dyslipidemia and/or requiring cholesterol lowering medications
number and percentage
Measured: 12 months, 24 months, 36 months
Mean and change in weight and BMI from baseline
mean and percent change
Measured: 12 months, 24 months, 36 months
Mean and change in waist, hip, and thigh circumference from baseline
mean and percent change
Measured: 12 months, 24 months, 36 months
Change in SF-36 scores of questionnaire from baseline
The MOS 36-Item Short-Form Health Survey
Measured: 12 months, 24 months, 36 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)
percent change in high-sensitivity C-reactive protein (hs-CRP)
Measured: 12 months, 24 months, 36 months
Change in Systolic Blood Pressure (SBP)
Change in Systolic Blood Pressure (SBP) at 12 months, 24 months, 36 months
Measured: 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
Measured: 12 months, 24 months, 36 months
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
Measured: 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Dec 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Ansan Hospital, Korea University Guro Hospital, Chonnam National University Hospital, Kyung Hee University Hospital at Gangdong, Ajou University
- Responsible party
- Principal investigator, Sungsoo Park, Korea University Anam Hospital
- Investigators
- Sungsoo Park, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284943
- Sponsor's protocol ID
- STARDOM
- Acronym
- STARDOM
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2020
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04284943
- Acronym / sponsor ID
- STARDOM / STARDOM
- Conditions
- Gastric Cancer, Diabetes Mellitus, Type 2
- Keywords
- Gastric Cancer, Diabetes Mellitus, Type 2, Subtotal Gastrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Korea University Ansan Hospital, Korea University Guro Hospital, Chonnam National University Hospital, Kyung Hee University Hospital at Gangdong, Ajou University
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long limb Roux-en-Y reconstruction | Active comparator | Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomyLong limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer. |
| Conventional Roux-en-Y reconstruction | Active comparator | Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomyConventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer. |
| Billroth II reconstruction | Active comparator | Procedure: Billroth II reconstruction after subtotal gastrectomyBillroth II reconstruction method follows subtotal gastrectomy for gastric cancer |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long limb Roux-en-Y reconstruction after subtotal gastrectomyThe 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). | Procedure or surgery | Long limb Roux-en-Y reconstruction |
| Conventional Roux-en-Y reconstruction after subtotal gastrectomyThe 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). | Procedure or surgery | Conventional Roux-en-Y reconstruction |
| Billroth II reconstruction after subtotal gastrectomyThe 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) | Procedure or surgery | Billroth II reconstruction |
Primary outcome
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
19 secondary outcomes
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
Success rate of biochemical resolution of diabetes
Time frame: 12 months, 24 months, 36 months
Success rate of biochemical improvement of diabetes
Time frame: 12 months, 24 months, 36 months
Change in glycated hemoglobin from baseline
Time frame: 12 months, 24 months, 36 months
Change in fasting plasma glucose level from baseline
Time frame: 12 months, 24 months, 36 months
Change in total cholesterol
Time frame: 12 months, 24 months, 36 months
Change in triglyceride
Time frame: 12 months, 24 months, 36 months
Change in High-density Lipoprotein (HDL)
Time frame: 12 months, 24 months, 36 months
Change in Low-density Lipoprotein (LDL)
Time frame: 12 months, 24 months, 36 months
Use of diabetes medication
Time frame: 12 months, 24 months, 36 months
Patients with hypertension and/or requiring antihypertensive therapy
Time frame: 12 months, 24 months, 36 months
Patients with dyslipidemia and/or requiring cholesterol lowering medications
Time frame: 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 change in waist, hip, and thigh circumference from baseline
Time frame: 12 months, 24 months, 36 months
Change in SF-36 scores of questionnaire from baseline
Time frame: 12 months, 24 months, 36 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: 12 months, 24 months, 36 months
Change in Systolic Blood Pressure (SBP)
Time frame: 12 months, 24 months, 36 months
The Side Effects and /or Complications of each surgical procedure
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sungsoo Park, MD, PhD principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long limb Roux-en-Y reconstruction after subtotal gastrectomy, Conventional Roux-en-Y reconstruction after subtotal gastrectomy and Billroth II reconstruction after subtotal gastrectomy in people with Gastric Cancer and Diabetes Mellitus, Type 2, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sungsoo Park, MD, PhD (+82 2 920 6772, kugspss@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5% (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.