Photodynamic Therapy (PDT) for Palliation of Cholangiocarcinoma
关键词
抽象
描述
Cholangiocarcinoma (CCA) is the second most common malignancy arising within the liver, and the association of this malignant condition with high morbidity and mortality is well recognized. It originates from the epithelium of bile ducts or ductules. Two types have been described: the peripheral type occurring in the parenchyma of the liver and the central type occurring within or related to the major bile ducts. Surgery can offer a curative chance, but only a minority of patients are candidates for this therapy at initial presentation since most patients are found with an unresectable tumor.
In unresectable cases, the median survival is 6 months. Since morbidity and mortality from CCA occurs because of biliary obstruction, successful palliation of that complication is the main goal in these patients. Surgical biliary bypass can be offered in order to prolong life and relieve symptoms. This intervention is unfortunately complicated by 30-day postoperative mortality rate between 7 and 24%. Moreover, the quality of life following surgery is only improved in a minority because of the time needed to recover from surgery.
Endoscopic biliary stenting during endoscopic retrograde cholangiopancreatography (ERCP) offers relief from obstructive jaundice without the high morbidity and mortality associated with surgery. In addition, a study by Luman et al even showed significant improvement in emotional, cognitive and global health scores following stenting. But this relief is unfortunately temporary since stents tend to become obstructed.
Local therapies including iridium brachytherapy and photodynamic therapy (PDT) may prevent or postpone these problems.
For more information about PDT, please see the 'Citations' section.
日期
| 最后验证: | 01/31/2017 |
| 首次提交: | 02/29/2012 |
| 提交的预估入学人数: | 12/17/2012 |
| 首次发布: | 12/20/2012 |
| 上次提交的更新: | 02/15/2017 |
| 最近更新发布: | 02/19/2017 |
| 实际学习开始日期: | 01/31/2012 |
| 预计主要完成日期: | 01/21/2018 |
| 预计完成日期: | 03/21/2018 |
状况或疾病
干预/治疗
Procedure: PDT Group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: PDT Group Subjects who receive Photodynamic therapy with plastic optic diffuser. | Procedure: PDT Group Photofrin and Photodynamic therapy using the plastic optic diffuser, conducted during Standard of care Endoscopic retrograde cholangiopancreatography (ERCP) |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patient with cholangiocarcinoma - Patient is age 18 years or older - Patient is receiving Photodynamic therapy with stent(s) placement as part of their original treatment plan - Patients must have adequate coagulation as defined below: Patient's INR ≤ 2 within 30 days of treatment Patient's platelets > 50,000/cmm within 30 days of treatment Exclusion Criteria: - Subject has acute porphyria. Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity. - Subject is pregnant. - Subject is allergic to Photofrin. - Subject has uncorrected coagulopathy - Subject is unstable for ERCP |
结果
主要结果指标
1. Efficacy Profile [2 months]
次要成果指标
1. Safety Profile [2 months]
