Skip to content

An exploratory clinical study on the effects of different ways of gastrointestinal reconstruction on blood glucose and prognosis in patients with distal gastric cancer complicated with type ? diabetes mellitus

An exploratory clinical study on the effects of different ways of gastrointestinal reconstruction on blood glucose and prognosis in patients with distal gastric cancer complicated with type ? diabetes mellitus

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038545
Enrollment
Unknown
Registered
2020-09-23
Start date
2020-10-15
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Distal gastric cancer complicated with type ? diabetes mellitus

Interventions

Group 1:Billroth I anastomosis of distal gastric cancer
Group 2:Billroth II anastomosis of distal gastric cancer
Group 3:Radical resection of distal gastric cancer with Roux-en-Y anastomosis

Sponsors

The First Affiliated Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with initially resectable distal gastric cancer confirmed by gastroscopy and pathology; 2. TxNxM0 patients without distant organ metastasis; 3. During oral glucose tolerance test, 2 h blood glucose >=11.1 mmol/ml; 4. Glycosylated hemoglobin A1c >=6.5%; 5. Fasting blood glucose FPG >=7.0mmol/l. Fasting is defined as no calorie intake for at least 8 hours; 6. Random blood glucose >=11.1 mmol/l in patients with typical hyperglycemia or hyperglycemia crisis symptoms; 7. The history of diabetes mellitus less than 15 years; 8. Been cured and discharged from hospital after operation, and the estimated survival time was more than 6 months. 9. Evaluation of cardiopulmonary function can tolerate anesthesia and surgery; 10. Aged 18-80 years old; 11. The subjects voluntarily joined the study and signed an informed consent form with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Preoperative evaluation of patients who need total gastrectomy or proximal gastrectomy; 2. Patients with distant metastasis or colleagues with other tumors; 3. Preoperative evaluation of cardiopulmonary function can not tolerate anesthesia and surgery; 4. Patients with a history of gastrointestinal surgery; 5. Patients with chronic hepatitis (such as hepatitis B, hepatitis C, autoimmune hepatitis), liver cirrhosis (alcoholic cirrhosis, viral cirrhosis, unexplained cirrhosis), and patients undergoing liver transplantation. 6. Patients with chronic pancreatitis and immune pancreatic disease; 7. Chronic diseases complicated with long-term hormone therapy; 8. Subjects are being treated with immunosuppressants, or systemic or absorbable local hormones for immunosuppressive purposes (dose > 10mg/ prednisone or other therapeutic hormones) and continue to use them within 2 weeks before entering the group; 9. The subjects had acute cardio-cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 3 months, and the cardiovascular clinical symptoms or diseases could not be well controlled; 10. Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders; 11. According to the judgment of the researchers, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 12. The researchers believe that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Fasting glucose;Postprandial blood glucose;

Secondary

MeasureTime frame
1Y-RFS;1Y-OS;OS;RFS;QoL;

Countries

China

Contacts

Public ContactHu Sanyuan

The First Affiliated Hospital of Shandong First Medical University

husanyuan1962@hotmail.com+86 18560086333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026