CClinicalTrials.gg
Sign In
RecruitingNCT04284943STARDOMUpdated Aug 7, 2026

Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

An interventional study of Long limb Roux-en-Y reconstruction after subtotal gastrectomy and Conventional Roux-en-Y reconstruction after subtotal gastrectomy in Gastric Cancer and Diabetes Mellitus, Type 2, sponsored by Korea University Anam Hospital. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Korea University Anam Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 69 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gastric Cancer
  • Diabetes Mellitus, Type 2

Keywords

  • Gastric Cancer
  • Diabetes Mellitus, Type 2
  • Subtotal Gastrectomy
03

Who can participate

Ages eligible
20 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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

  • Active comparator
    Billroth II reconstruction

    Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer

    Procedure: Billroth II reconstruction after subtotal gastrectomy

Interventions

  • ProcedureLong 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).

  • ProcedureConventional 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).

  • ProcedureBillroth 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)

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  1. 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

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

  2. 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)

    Time frame: 12 months, 24 months, 36 months

  3. 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)

    Time frame: 12 months, 24 months, 36 months

  4. Change in glycated hemoglobin from baseline

    percent change

    Time frame: 12 months, 24 months, 36 months

  5. Change in fasting plasma glucose level from baseline

    percent change

    Time frame: 12 months, 24 months, 36 months

  6. Change in total cholesterol

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

    Time frame: 12 months, 24 months, 36 months

  7. Change in triglyceride

    Percent change in triglyceride at 12 months, 24 months, 36 months

    Time frame: 12 months, 24 months, 36 months

  8. Change in High-density Lipoprotein (HDL)

    Percent change in high-density lipoprotein (HDL) at 12 months, 24 months, 36 months

    Time frame: 12 months, 24 months, 36 months

  9. Change in Low-density Lipoprotein (LDL)

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

    Time frame: 12 months, 24 months, 36 months

  10. Use of diabetes medication

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

    Time frame: 12 months, 24 months, 36 months

  11. Patients with hypertension and/or requiring antihypertensive therapy

    number and percentage

    Time frame: 12 months, 24 months, 36 months

  12. Patients with dyslipidemia and/or requiring cholesterol lowering medications

    number and percentage

    Time frame: 12 months, 24 months, 36 months

  13. Mean and change in weight and BMI from baseline

    mean and percent change

    Time frame: 12 months, 24 months, 36 months

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

    mean and percent change

    Time frame: 12 months, 24 months, 36 months

  15. Change in SF-36 scores of questionnaire from baseline

    The MOS 36-Item Short-Form Health Survey

    Time frame: 12 months, 24 months, 36 months

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

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

    Time frame: 12 months, 24 months, 36 months

  17. Change in Systolic Blood Pressure (SBP)

    Change in Systolic Blood Pressure (SBP) at 12 months, 24 months, 36 months

    Time frame: 12 months, 24 months, 36 months

  18. The Side Effects and /or Complications of each surgical procedure

    number of the Side Effects and /or Complications of each surgical procedure

    Time frame: 12 months, 24 months, 36 months

  19. 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

    Time frame: 24 months, 36 months

06

Study locations

1 of 1 sites recruiting
  • Korea University Anam Hospital
    Seoul, 02841, South Korea
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04284943
Lead sponsor
Korea University Anam Hospital
Collaborators
Korea University Ansan Hospital, Korea University Guro Hospital, Chonnam National University Hospital, Kyung Hee University Hospital at Gangdong, Ajou University
Responsible party
Sungsoo Park (Professor, Korea University Anam Hospital) — Principal investigator
First posted
Feb 26, 2020
Start date
Dec 1, 2020
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 7, 2026

Study contacts

Sungsoo Park, MD, PhD
Contact
kugspss@korea.ac.kr
+82 2 920 6772
Yeongkeun Kwon, MD, PhD
Contact
kukwon@korea.ac.kr
+82 2 920 6772
Sungsoo Park, MD, PhD
principal investigator · Korea University Anam Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stomach Neoplasms→

Other studies from this sponsor

Korea University Anam Hospital

Start the discussion