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the study evaluate the efficacy and safety of EUS-RFA using Habib EUS-RFA catheter with a prospective randomised trial in patients with inoperable PDAC.
The five year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency ablation (RFA) has been developed in our unit and used in patients with unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection. Endoscopic ultrasound guided RFA (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-RFA group | Experimental | Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy |
|
| control group | Active Comparator | the control group will receive chemoradiotherapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound guided radiofrequency ablation | Procedure | Endoscopic ultrasound guided radiofrequency ablation (EUS-RFA) will be done in 3 different sessions with 2 weeks interval between each session on Day 1, Day 15 and Day 30. Each session will involve multiple applications of EUS-RFA (up to 10) with RF setting of 25 Watts over 90 seconds for each application. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tumour size as measured on EUS and or CT | The tumor size was compared before and after 60 days EUS-RFA | 60 days |
| Change in serum levels of Ca 19-9 | Serum levels of Ca 19-9 was compared before and after 60 days EUS-RFA | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival at 6 months | Survival rate 6 months after EUS-RFA | 6 months |
| Overall survival at 12 months | Survival rate 12 months after EUS-RFA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zhang | First People's Hospital of Hangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianfeng Yang | Hangzhou | Zhejiang | 310006 | China | ||
| Hangzhou First People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23049547 | Background | Gaidhane M, Smith I, Ellen K, Gatesman J, Habib N, Foley P, Moskaluk C, Kahaleh M. Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) of the Pancreas in a Porcine Model. Gastroenterol Res Pract. 2012;2012:431451. doi: 10.1155/2012/431451. Epub 2012 Sep 20. |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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|
|
| chemoradiotherapy | Radiation | Receive chemoradiotherapy |
|
| 12 months |
| Hangzhou |
| Zhejiang |
| 31006 |
| China |