Endoscopic Abraxane Injection Into Pancreatic Cysts
Түлхүүр үгс
Хураангуй
Тодорхойлолт
You will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. Screening tests include the following: medical history, performance status, assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test.
If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria you will not be able to participate in this research study.
As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA (Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel will be injected into the cyst cavity.
The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during the EUS-FNA. 2 days after the procedure you will receive a phone call from the research coordinator to check on how you are feeling. 3 months after study procedure participants will undergo a follow up CT to see what happened to the cyst. You will continue to have routine follow up for your medical problems.
Огноо
| Сүүлд баталгаажуулсан: | 08/31/2014 |
| Эхлээд оруулсан: | 09/30/2012 |
| Тооцоолсон элсэлтийг оруулсан: | 09/30/2012 |
| Эхлээд нийтэлсэн: | 10/02/2012 |
| Сүүлийн шинэчлэлтийг оруулсан: | 05/25/2017 |
| Сүүлийн шинэчлэлтийг нийтэлсэн: | 06/20/2017 |
| Эхний ирүүлсэн үр дүнгийн огноо: | 05/25/2017 |
| Анхны ирүүлсэн QC-ийн үр дүнгийн огноо: | 05/25/2017 |
| Эхний байрлуулсан үр дүнгийн огноо: | 06/20/2017 |
| Сургалтын бодит эхлэх огноо: | 10/31/2012 |
| Тооцоолсон анхан шатны ажил дуусах огноо: | 08/31/2014 |
| Судалгааны ажлыг дуусгах өдөр: | 08/31/2014 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Drug: Albumin bound paclitaxel
Үе шат
Arm Groups
| Гар | Хөндлөнгийн оролцоо / эмчилгээ |
|---|---|
| Experimental: Albumin bound paclitaxel Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. | Drug: Albumin bound paclitaxel Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. |
Эрхийн шалгуур
| Суралцах боломжтой нас | 18 Years Хэнд 18 Years |
| Суралцах боломжтой хүйс | All |
| Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
| Шалгуур үзүүлэлтүүд | Inclusion Criteria: - Mucinous cysts (premalignant or malignant cysts of the pancreas) - Normal organ and marrow function - Baseline CT within 6 months of enrollment Exclusion Criteria: - Pregnant or breastfeeding - Acute active pancreatitis - Complicated pancreatic cysts - Subjects who do not speak English |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. Frequency of Pancreatitis [3-10 months (median 6 months) after injection therapy]
Хоёрдогч үр дүнгийн арга хэмжээ
1. Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts [immediately after procedure]
2. Size of Cystic Lesion [3-10 months (median 6 months) after injection therapy]
