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to assess the effecacy of Ulinastatin for postoperative incidence rate of complications following pancreaticoduodenectomy

Placebo control, double blind, randomized clinical trial to assess the effecacy of Ulinastatin for postoperative incidence rate of complications following pancreaticoduodenectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002160
Enrollment
Unknown
Registered
2012-05-08
Start date
2012-06-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

postoperative complications following pancreaticoduodenectomy

Interventions

experimental group:treatment with Ulinastatin
control:Placebo

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with malignant tumors located in Vater ampulla or in the inferior segment of common bile duct, head of pancreas,or duodenum; 2. Pancreaticoduodenectomy for patients with benign tumors, such as large inflammatory mass in the head of pancreas, or uncertain properties of mass in the head of pancreas during the operation; 3. The operation. combined with the pancreatoduodenectomy in order to achieve radical resection for patients with colon or gastric cancer invading the head of pancreas or duodenum; 4. Age from 18 to 80 years old; 5. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Cannot do the pancreatoduodenectomy during the Surgical exploration; 2. Patients cannot suffer the operation with the serious dieases, such as the heart, brain, lung, liver, or kidney dysfunction; 3. Patients with severe mental illness, including dementia; 4. known pregnant or lactating women; 5. Patients with a history of ulinastatin allergies, or highly allergic to ulinastatin; 6. Participated in the other drug experiments in the past three months; 7. Patients in a dying state.

Design outcomes

Primary

MeasureTime frame
incidence rate of complication;

Countries

China

Contacts

Public ContactXubao Liu
xbliu@medmail.com.cn+86 18980601486

Outcome results

None listed

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