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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| regional interventional chemotherapy group | Experimental |
| |
| systemic chemotherapy | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regional interventional chemotherapy group | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| overall surviva | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate | 12 months | |
| The median progression-free survival PFS | 12 months | |
| Drug Toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Tie, PH.D., MD | Contact | +86-29-84771528 | tiejun7776@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guohong Han, MD | Xijing Hospital of Digestive Diseases, Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases, Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16412037 | Background | Han GH, Yin ZX, Meng XJ, He CY, Zhang HB, Sun AH, Wu KC, Ding J, Fan DM. Prospective randomized clinical trial of two drug delivery pathway in the treatment of inoperable advanced pancreatic carcinoma. Chin J Dig Dis. 2006;7(1):45-8. doi: 10.1111/j.1443-9573.2006.00243.x. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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|
The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity.
| 18 months |
| surgical complications | Major surgical complications included allergic reaction to the contrast agent, local hematoma, pneumothorax, puncture site bleeding, wound infection, delayed healing or cracking, port-catheter blockage, and necrosis of the tissue surrounding the port-catheter. | 18 months |
| Xijing Hospital of Digestive Diseases, Fourth Military Medical University |
| Xi'an |
| Shaanxi |
| 710032 |
| China |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |