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Biliary Tract Tumors

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound for this condition is being researched in clinical trials.

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with biliary tract tumors. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

There is also a page dedicated to Biliary Tract Obstruction, which includes a disease outside of the biliary pathway that can cause obstructive symptoms. 

How it Works
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated. One mechanism is the production of precise ablation, or thermal destruction of tissue, with the goal of complete or partial ablation of the cancer. Partial ablation may allow better placement of a biliary stent. A second mechanism is the use of focused ultrasound to activate sonosensitizer therapeutics, such as epirubicin. The combination of focused ultrasound and epirubicin results in the formation of a cytotoxic reactive oxygen molecules in the region of the tumor.

Advantages
The primary options for treatment for malignancies of the biliary tract include chemotherapy, but radiation therapy or surgery can also be used.

For certain patients, focused ultrasound could provide an enhanced method of chemotherapy treatment or a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing, surgical complications, or anesthesia – at a lower cost. The sonodynamic approach can enhance the chemotherapy levels in the desired region, while minimizing the exposure of the rest of the body. Furthermore, the approach can be repeated, if necessary.

Clinical Trials

Researchers in Japan are using sonodynamic therapy to activate chemotherapeutic agents in patients with biliary tract cancer. 

At the present time, there are no other clinical trials recruiting patients for biliary duct tumors treatments.

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/. 

Regulatory Approval and Reimbursement

Focused ultrasound treatment for biliary duct tumors is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Zhang FQ, Li L, Huang PC, Xia FF, Zhu L, Cao C. Stent Insertion With High Intensity-Focused Ultrasound Ablation for Biliary Obstruction Caused by Pancreatic Carcinoma: A Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2021 Feb 17. doi: 10.1097/SLE.0000000000000918.

Cai PF, Gu H, Zhu LJ, Xu YS, Deng HY. Stent insertion with high-intensity focused ultrasound ablation for malignant biliary obstruction: A protocol of systematic review and meta-analysis. Medicine (Baltimore). 2021 Jan 22;100(3):e23922. doi: 10.1097/MD.0000000000023922.

Click here for additional references from PubMed.