Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
NCT01665625 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2012-08-15
Summary
Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic cancer for over two decades and combinations of gemcitabine with different chemotherapeutic drugs have been investigated to improve the outcomes of pancreatic cancer. However, no substantial improvement in patient survival has been achieved. Locoregional chemotherapy via intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug concentrations and reducing systemic toxicities. In this study, the investigators hypothesis that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy. The investigators will analyze and evaluate the effect and safety of an implanted percutaneous left subclavian artery port-catheter drug delivery system for regional chemotherapy of inoperable pancreatic carcinoma.
Conditions
- Unresectable Pancreatic Cancer
Interventions
- PROCEDURE
-
regional interventional chemotherapy group
The patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was used to place the port-catheter drug delivery system in the celiac artery (pancreatic head) or the hepatic artery (pancreatic body and tail). Finally, the port-catheter was embedded under the left upper chest.
Sponsors & Collaborators
-
Air Force Military Medical University, China
lead OTHER
Principal Investigators
-
Guohong Han, MD · Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2015-08-31
- Completion
- 2016-02-29
Countries
- China
Study Locations
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