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Clinical study for efficacy and safety of ERCP/PTCD infusion drug packaging microparticles in the treatment of cholangiocarcinoma

Clinical study for efficacy and safety of ERCP/PTCD infusion drug packaging microparticles in the treatment of cholangiocarcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020111
Enrollment
Unknown
Registered
2018-12-14
Start date
2018-12-11
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

Cholangiocarcinoma

Interventions

Case series:ERCP/PTCD infusion drug packaging microparticles

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients must meet all the following criteria to be allowed to participate in clinical trials: 1. Patients with cholangiocarcinoma type I, type II and type III were diagnosed by pathology or clinical examination. 2. Patients without surgical indications, failure or intolerance of radiotherapy and chemotherapy; 3. No intravenous chemotherapy, radiotherapy and local administration of bile duct were performed in the past 4 weeks. 4. KPS = 60 points; 5. Aged 18 -85 years old; 6. Blood routine is generally normal; 7. Prothrombin function is generally normal(prothrombin international standardized ratio INR<1.5), no bleeding tendency; 8. BUN and Cr = 1.5 times normal upper limit(ULN) or creatinine clearance = 60mL/min; 9. No other serious cardiopulmonary diseases, etc.; 10. Patients agree to join the group and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Patients with one of the following conditions can not participate or continue the clinical trial: 1. Breast-feeding, pregnant or preparing for pregnancy; 2. Patients with documented hypersensitivity to test sample ingredients or their analogues; 3. Patients with cognitive dysfunction or with poor compliance; 4. Participation in other clinical trials within 4 weeks; 5. Patients with PTCD and ERCP contraindications; 6. Patients with stents placed before treatment; 7. Patients combined with other severe, acute or chronic diseases that may interfere with the the results of this study; 8. Patients not fitted for this study determined by the investigators.

Design outcomes

Secondary

MeasureTime frame
Quality of life assessment;Changes in bile drainage;Total lifetime;

Primary

MeasureTime frame
The imaging changes of bile duct stenosis before and after treatment were compared by MRCP.;

Countries

China

Contacts

Public ContactFang Yao

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

yaofang99@sina.com+86 13511073309

Outcome results

None listed

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