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
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.
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Korea University Anam Hospital is the lead sponsor of 112 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.
Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomy
Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.
Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomy
Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer
Procedure: Billroth II 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).
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).
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)
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
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
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
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
Change in glycated hemoglobin from baseline
percent change
Time frame: 12 months, 24 months, 36 months
Change in fasting plasma glucose level from baseline
percent change
Time frame: 12 months, 24 months, 36 months
Change in total cholesterol
Percent change in total cholesterol at 12 months, 24 months, 36 months
Time frame: 12 months, 24 months, 36 months
Change in triglyceride
Percent change in triglyceride at 12 months, 24 months, 36 months
Time frame: 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
Time frame: 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
Time frame: 12 months, 24 months, 36 months
Use of diabetes medication
number of diabetes medication at 12 months, 24 months, 36 months
Time frame: 12 months, 24 months, 36 months
Patients with hypertension and/or requiring antihypertensive therapy
number and percentage
Time frame: 12 months, 24 months, 36 months
Patients with dyslipidemia and/or requiring cholesterol lowering medications
number and percentage
Time frame: 12 months, 24 months, 36 months
Mean and change in weight and BMI from baseline
mean and percent change
Time frame: 12 months, 24 months, 36 months
Mean and change in waist, hip, and thigh circumference from baseline
mean and percent change
Time frame: 12 months, 24 months, 36 months
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2020 (actual). Primary completion is estimated for Dec 2027, 84 months after the start.
Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 84 months is above that.
Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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