Oncometabolic Surgery

NCT07437573 | Completed Phase 3

• 1 other identifier: 2020GR0002
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 1)Primary Endpoint

  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 Outcomes (1)

• 2)Secondary Endpoint

  one year after surgery.

Study Arms (1)

Multicenter Prospective Randomized Controlled Study

ACTIVE COMPARATOR

* 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

Interventions

long-limb Roux-en-Y gastrojejunostomy PROCEDURE

* 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

Multicenter Prospective Randomized Controlled Study

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Korea University Guro Hospital

Seoul, Gurogu, 08308, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 27, 2026
• Study Start: July 7, 2020
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

KR (1)