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A Clinic trial for prevention of the post-pancreaticoduodenectomy pancreatic fistula by octreotide.

A single center, prospective, randomized, controlled, double blind trial for the prevention of post-pancreaticoduodenectomy pancreatic fistula by octreotide.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029555
Enrollment
Unknown
Registered
2020-02-04
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-02-10

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

Conditions

pancreatic fistula

Interventions

experimental group (octreotide group):The first dose of octreotide was 0.1 mg after the beginning of ventilator-assisted breathing, and then subcutaneously injected every 8 hours. 0.1 mg for 5 days,
control group (saline group):The control group was successfully intubated under anesthesia before operation. After the beginning of ventilator-assisted breathing, the first dose of saline was given, a

Sponsors

Department of Biliary-Pancreatic Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Han nationality; (2) >=18 years and <= 75 years; (3) Elective surgery of pancreaticoduodenectomy (CHILD digestive tract reconstruction); (4) Informed consent and signature of informed consent; (5) The preoperative jaundice index was less than 250umol/L; (6) Chemotherapy and abdominal radiotherapy were not performed within 6 months before operation. (7) No long-term history of adrenocortical hormones and immunosuppressive agents for various reasons; (8) Compliance with ASA Class I-II standards; (9) BMI: 18.5-24.9Kg/m2.

Exclusion criteria

Exclusion criteria: (1) Important organs (such as heart, lung, liver, brain and kidney) dysfunction; (2) Postoperative patients without receiving R0 resection of malignant lesion; (3) Sudden cardio-cerebrovascular accident or other serious postoperative complications caused by non-pancreatic leakage.

Design outcomes

Primary

MeasureTime frame
Blood amylase;Amylase in drainage fluid;

Secondary

MeasureTime frame
Liver function;Renal function;Routine blood test;Bacterial culture and drug sensitivity test of drainage fluid;

Countries

China

Contacts

Public ContactHua Rong

Renji Hospital, School of Medicine, Shanghai Jiaotong University

13611657722@sina.cn+86 13611657722

Outcome results

None listed

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