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)
New Surgery Technique Explored for Gastric Cancer Patients with Diabetes
Plain English Summary
Oncometabolic Surgery is a Phase 3 clinical trial sponsored by Korea University Guro Hospital studying Gastric Cancer. This trial tests a new surgical method called 'long-limb Roux-en-Y reconstruction' compared to the standard method after stomach removal surgery for gastric cancer. It is for patients diagnosed with early-stage gastric cancer who also have type 2 diabetes. Participation involves undergoing one of two surgical techniques for stomach cancer and then being monitored for a year. The alternative is the conventional Roux-en-Y reconstruction, which is the current standard surgical approach. The trial aims to enroll 94 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with early-stage (Stage I) gastric cancer. Individuals aged 20 to 80 years old. People diagnosed with type 2 diabetes. Patients with a body mass index (BMI) of 23 or higher. This trial is studying Gastric Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well patients' diabetes is controlled one year after surgery, indicating the potential of the new technique to manage blood sugar levels. The specific primary outcome measures are: 1)Primary Endpoint (one year after surgery.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial explores a new surgical approach that may help improve diabetes control in gastric cancer patients, addressing a gap in managing both conditions simultaneously. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Gastric Cancer, where improved treatment options are needed.
Investor Insight
This trial investigates a novel surgical technique with potential to improve outcomes for a specific patient population, suggesting a business opportunity in specialized oncological and metabolic surg Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if the 'long-limb Roux-en-Y reconstruction' is suitable for your specific condition and if it differs significantly from standard surgery. Understand that participation means you will be randomly assigned to either the new or standard surgical method. Be prepared for regular follow-up appointments and tests for one year after surgery to monitor your health and diabetes control. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 94 participants
Interventions
- 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
Primary Outcomes
- 1)Primary Endpoint (one year after surgery.)
Secondary Outcomes
- 2)Secondary Endpoint (one year after surgery.)
Full Eligibility Criteria
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
Trial Locations
- Korea University Guro Hospital, Seoul, Gurogu, South Korea
Frequently Asked Questions
What is clinical trial NCT07437573?
NCT07437573 is a Phase 3 INTERVENTIONAL study titled "Oncometabolic Surgery." It is currently completed and is sponsored by Korea University Guro Hospital. The trial targets enrollment of 94 participants.
What conditions does NCT07437573 study?
This trial investigates treatments for Gastric Cancer. The primary condition under study is Gastric Cancer.
What treatments are being tested in NCT07437573?
The interventions being studied include: 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
What does Phase 3 mean for NCT07437573?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07437573?
This trial is currently "Completed." It started on 2020-07-07. The estimated completion date is 2024-05-07.
Who is sponsoring NCT07437573?
NCT07437573 is sponsored by Korea University Guro Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07437573?
The trial aims to enroll 94 participants. The trial status is completed.
How is NCT07437573 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07437573?
The primary outcome measures are: 1)Primary Endpoint (one year after surgery.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07437573 being conducted?
This trial is being conducted at 1 site, including Seoul, Gurogu (South Korea).
Where can I find official information about NCT07437573?
The official record for NCT07437573 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07437573. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07437573 testing in simple terms?
This trial tests a new surgical method called 'long-limb Roux-en-Y reconstruction' compared to the standard method after stomach removal surgery for gastric cancer. It is for patients diagnosed with early-stage gastric cancer who also have type 2 diabetes.
Why is this trial significant?
This trial explores a new surgical approach that may help improve diabetes control in gastric cancer patients, addressing a gap in managing both conditions simultaneously. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07437573?
Potential risks include those associated with any major surgery, such as infection, bleeding, or complications from anesthesia. Specific risks related to the new technique might include issues with digestion or nutrient absorption, though the study aims to assess these. Side effects could involve changes in bowel habits, dumping syndrome (feeling sick after eating), or continued challenges with diabetes management. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07437573?
Ask your doctor if the 'long-limb Roux-en-Y reconstruction' is suitable for your specific condition and if it differs significantly from standard surgery. Understand that participation means you will be randomly assigned to either the new or standard surgical method. Be prepared for regular follow-up appointments and tests for one year after surgery to monitor your health and diabetes control. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07437573 signal from an investment perspective?
This trial investigates a novel surgical technique with potential to improve outcomes for a specific patient population, suggesting a business opportunity in specialized oncological and metabolic surg This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves undergoing one of two surgical techniques for stomach cancer and then being monitored for a year. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Gastric Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.