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Effects of somatostatin analogues on pancreatic leakage after gastric cancer surgery

Effects of somatostatin analogues on pancreatic injury after gastric cancer surgery: A multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056201
Enrollment
Unknown
Registered
2022-02-01
Start date
2022-02-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Gastrointestinal diseases

Interventions

experimental group:Somatostatin analogue is micropumped 0.3mg q8h
control group:Same volume of NS is micropumped

Sponsors

Shandong Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and 3 times ULN measured values of serum amylase; 5. Willingness to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Persons with mental disorders or unable to cooperate; 2. Preoperative history of pancreatitis or blood amylase above 2 times the upper limit; 3. Pancreatectomy or short-circuit surgery was performed when the tumor advanced or invaded the pancreas; 4. Unstable vital signs or hemodynamics; 5. Somatostatin and its analogues were used in the last 1 week; 6. Refractory shock; 7. Malignant or irreversible diseases with an expected mortality rate of more than 50% within six months; 8. History of allergy to the test drug; 9. Severe metabolic diseases; 10. Severe liver and kidney insufficienc; 11. Immunodeficiency, immunosuppression or autoimmune disease; 12. History of hemorrhagic disease; 13. Preoperative pulmonary infection or respiratory disease; 14. Intracranial hemorrhage one month before enrollment; 15. Pregnant or lactating women; 16. Have been enrolled in other clinical studies or have been enrolled in this study.

Design outcomes

Primary

MeasureTime frame
Pancreatic leakage;Serum amylase concentration;Amylase concentration in ascites;

Secondary

MeasureTime frame
Peritoneal drainage volume;Drainage duration;Anastomotic leakage;Abdominal cavity infection;Time to return of flatus;Duration of hospital stays;Hospital costs;

Countries

China

Contacts

Public ContactJing Changqing

Shandong Provincial Hospital Affiliated to Shandong First Medical University

jing66510122@sina.com+86 15168888987

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026