An interventional study of Endoscopic ultrasound guided radiofrequency ablation and chemoradiotherapy in Pancreatic Adenocarcinoma Non-resectable, sponsored by First People's Hospital of Hangzhou. Completed at 2 sites in China. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-30.
Sponsored by First People's Hospital of Hangzhou · Not applicable, Interventional, and Treatment
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 .
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 38 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →First People's Hospital of Hangzhou is the lead sponsor of 70 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy
Procedure: Endoscopic ultrasound guided radiofrequency ablation · Radiation: chemoradiotherapy
the control group will receive chemoradiotherapy only
Radiation: chemoradiotherapy
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.
Also known as: EUS-RFA
Receive chemoradiotherapy
Change in tumour size as measured on EUS and or CT
The tumor size was compared before and after 60 days EUS-RFA
Time frame: 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
Time frame: 60 days
Overall survival at 6 months
Survival rate 6 months after EUS-RFA
Time frame: 6 months
Overall survival at 12 months
Survival rate 12 months after EUS-RFA
Time frame: 12 months
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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First People's Hospital of Hangzhou