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Oncometabolic Surgery

Comparison of the Long-limb vs. Conventional Roux-en-Y Reconstruction After Distal Gastrectomy in Gastric Cancer Patients With Type II Diabetes(Multicenter Prospective Randomized Controlled Study)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07437573
Acronym
KLASS-09
Enrollment
94
Registered
2026-02-27
Start date
2020-07-07
Completion date
2024-05-07
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Brief summary

Recently, the concept of "Onco-metabolic surgery" has emerged, and it is a theory that if anastomosis bypassing the duodenum and upper jejunum is performed after gastrectomy in gastric cancer patients with type 2 diabetes, diabetes can be expected to improve. The authors would like to compare and analyze the effect of long bowel Luwai gastrointestinal anastomosis in gastric cancer patients with type 2 diabetes in a multicenter prospective manner with that of type 2 diabetes gastric cancer patients who underwent a conventional Luwai gastrointestinal anastomosis.

Detailed description

\<Research Design\> 1. Primary Endpoint * It examines whether there is a statistically significant difference in the proportion of patients with improved blood sugar control one year after surgery. * Here, "Improvement of blood sugar control" includes all of the following three cases (complete remission, partial remission and improvement) 1. IMPROVEMENT: Transition from insulin injection to oral hypoglycemic agents and reduction of diabetic medication dose due to reduction of glycated hemoglobin compared to preoperative 2. Partial remission: Stop taking diabetes medication and maintain fasting blood glucose 100 to 125 and glycated hemoglobin 6 to 6.4 3. Complete mission: Stop taking diabetes medication and maintain less than 100 fasting blood sugar and less than 6 glycated hemoglobin 2. Secondary Endpoint * Whether fasting blood glucose levels and glycated hemoglobin reduction at 1,3,6,12 months after surgery between the groups were significantly different * Comparison of significant differences in changes in nutritional factors at 1, 3, 6, and 12 months after surgery between groups * A Comparison of Significant Differences in Diabetes-Related Hormone Changes in 1, 3, and 12 Months After Surgery Between Groups \<Method of research\> 1. This study is a comparative study conducted with multicenter, prospective randomization. 2. How to operate * Before the start of surgery, the study group and the control group are selected by random assignment and the surgery is performed. * The target groups that met the criteria for selection of the study are randomly divided into two groups (study group: long bowel Luwai anastomosis group, and control group: existing Luwai anastomosis group). The assignment of the two groups is to contact the institution to which the entire clinical trial director belongs, that is, the research nurse at Korea University Guro Hospital, to receive a military assignment after the subject of the study is registered for each institution and before surgery. Randomization is performed according to a table using https://www.sealedenvelope.com/ , and in order to ensure a balanced distribution between the two groups, stratified block randomization is performed by each institution participating in this clinical trial. Therefore, the study subjects will be randomly assigned to either the research group or the control group at a ratio of 1:1 within the participating institution. * Research group (Long bowel Ruwai anastomosis group) * Laparoscopic or robotic lower subtotal resection and extensive lymph node resection * When performing the lower gastric subtotal resection, 70% of the total gastric volume should be resected and about 30% should be left including the bottom of the stomach. * When performing Luwai-type anastomosis, the length of the biliary tract pancreatic branch, which is the field finger, is 80 centimeters, and the length of the blade finger from the stomach-factory anastomosis is 80 centimeters. * Control (Existing Ruwai Anastomosis Group) * Laparoscopic or robotic lower subtotal resection (70% resection) and extensive lymph node resection * The length of the biliary tract pancreatic branch, which is a field finger, is 20 cm when performing the Luwai-type anastomosis according to the existing method Meter, the length of the blade from the upper-factory anastomosis part is 40 centimeters, and the upper-factory and factory- perform a jejunal anastomosis. Therefore, the difference in length between the two groups' diverted small intestine branches is 100 cm It's a meter. 3. Analysis method Among the patients to be studied in this study, sex and age of the study group scheduled to perform a long bowel Luwai anastomosis and the control group patients scheduled to perform a conventional Luwai anastomosis, the medical history period of diabetes before surgery, body obesity at 1, 3, and 12 months before and after surgery, fasting blood sugar levels, and glycated hemoglobin levels are compared. Blood is collected for the preoperative and postoperative tests (30 minutes, 60 minutes, 120 minutes after loading) in the study group and the control group and the hormone and related components (insulin, C-peptide, Adiponectin, Leptin, Ghrelin, GLP-1, GIP, PYY) that are expected to be related to metabolic control and diabetes improvement effects are investigated and analyzed. In addition, the degree of improvement in blood sugar control (no improvement, improvement: switching from insulin injection to oral hypoglycemic agents and reducing the dose of diabetic drugs, partial remission: maintaining fasting blood sugar from 100 to 125 without taking diabetic drugs, maintaining glycated hemoglobin 6 to 6.4 and complete remission: maintaining less than 100 fasting blood sugar without taking diabetic drugs) in the two groups is compared to examine the difference in blood sugar control effects according to changes in the length of anastomosis. In addition, we would like to conduct an analysis regarding the improvement of the plasma control effect to find out which factors can be the necessary requirements for improving diabetes control.

Interventions

PROCEDURElong-limb Roux-en-Y gastrojejunostomy

* Laparoscopic or robotic lower subtotal resection and extensive lymph node resection * When performing the lower gastric subtotal resection, 70% of the total gastric volume should be resected and about 30% should be left including the bottom of the stomach. * When performing Luwai-type anastomosis, the length of the biliary tract pancreatic branch, which is the field finger, is 80 centimeters, and the length of the blade finger from the stomach-factory anastomosis is 80 centimeters

Sponsors

Korea University Guro Hospital
Lead SponsorOTHER
Kyungpook National University Chilgok Hospital
CollaboratorOTHER
Samsung Medical Center
CollaboratorOTHER
Asan Medical Center
CollaboratorOTHER
Seoul National University Bundang Hospital
CollaboratorOTHER
Kyung Hee University Hospital at Gangdong
CollaboratorOTHER
Kosin University Gospel Hospital
CollaboratorOTHER
Dankook University
CollaboratorOTHER
Korea University Ansan Hospital
CollaboratorOTHER
Seoul National University Hospital
CollaboratorOTHER
Gangnam Severance Hospital
CollaboratorOTHER
Keimyung University Dongsan Medical Center
CollaboratorOTHER
Wonju Severance Christian Hospital
CollaboratorOTHER
Gyeongsang National University Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* Clinical Stage I Gastric Cancer * a patient aged 20 to 80 * Dx of Type 2 Diabetes * Preoperative BMI ≥ 23 kg/m2

Exclusion criteria

* If you have a history of cancer other than gastric cancer in the last five years * If you received chemotherapy treatment before gastric cancer surgery * Preoperative advanced gastric cancer is diagnosed, or gastric total resection is performed in the upper part * If you have a history of malabsorption

Design outcomes

Primary

MeasureTime frameDescription
1)Primary Endpointone year after surgery.Rate of more than improvement in diabetic control \- HbA1c \<6.5%, FBS 125 mg/dL \& not increase in antidiabetic medication requirement

Secondary

MeasureTime frameDescription
2)Secondary Endpointone year after surgery.Concentration of HbA1c \& FBS in postoperative 1 year Concentration of gut hormones related with diabetic control (Adiponectin, Ghrelin, Leptin, GLP-1 \& GIP)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026