Oncometabolic Surgery (KLASS-09)

February 25, 2026 updated by: Jong-Han Kim, Korea University Guro Hospital

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)

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.

Study Overview

Status

Status

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

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

<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.

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 (Actual)

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.
94

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.
  • Phase 3

Contacts and Locations

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

Study Locations

  • South Korea
    • Gurogu
      • Seoul, Gurogu, South Korea, 08308
        • Korea University Guro Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Multicenter Prospective Randomized Controlled Study
  • 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.
Procedure: long-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

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
1)Primary Endpoint
Time Frame: one year after surgery.

Rate of more than improvement in diabetic control

- HbA1c <6.5%, FBS 125 mg/dL & not increase in antidiabetic medication requirement
one year after surgery.

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
2)Secondary Endpoint
Time Frame: one 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)
one year after surgery.

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 Guro 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.
Samsung Medical Center
Asan Medical Center
Seoul National University Hospital
Seoul National University Bundang Hospital
Gyeongsang National University Hospital
Kyungpook National University Chilgok Hospital
Gangnam Severance Hospital
Keimyung University Dongsan Medical Center
Kyung Hee University Hospital at Gangdong
Wonju Severance Christian Hospital
Dankook University
Kosin University Gospel Hospital
Korea University Ansan 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.
July 7, 2020

Primary Completion (Actual)

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.
May 7, 2024

Study Completion (Actual)

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.
May 7, 2024

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).
January 27, 2026

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 24, 2026

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 27, 2026

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.
February 27, 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.
February 25, 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.
February 1, 2026

More Information

Terms related to this study

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.
  • 2020GR0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Age, gender, weight, BMI, Inbody (Option), duration of diabetes and diabetes treatment drugs, comorbidities other than diabetes, blood tests

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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