NCT06106750

Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent

The Efficacy and Safety of Endoscopic Scissors Cutting Nasobiliary Ducts in the Treatment of Malignant Hilar Biliary Tract Stenosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of endoscopic scissors cutting nasobiliary ducts in the treatment of malignant hilar biliary tract stenosis

Detailed description

The early diagnosis of hilar bile duct stenosis is difficult, and when the patient is diagnosed, the opportunity for surgical radical resection is lost, resulting in a poor prognosis. Effective palliative treatment can significantly improve their quality of life and survival time. The method of cutting nasobiliary ducts with endoscopic scissors has many advantages. Firstly, there are multiple lateral foramen of the nasobiliary duct, which increases the drainage area. Secondly, the nasobiliary duct can be retained in the secondary bile duct, which is difficult to achieve with a conventional stent. The use of nasobiliary ducts can also reduce the difficulty of converting from external drainage to internal drainage.

Conditions

• Cholangiocarcinoma, Hilar
• Biliary Stricture
• Hilar Cholangiocarcinoma
• Klatskin Tumor
• Biliary Disease
• Bile Duct Diseases
• Bile Duct Stenosis

Interventions

Type	Name	Description
DEVICE	Endoscopic nasobiliary duct cutting	Endoscopic retrograde cholangiopancreatography and endoscopic nasobiliary duct placement and drainage are conducted first. Upon achieving a postoperative state marked by satisfactory nasobiliary duct drainage and overall patient stability, the procedure entails the employment of endoscopic scissors. The tools are applied to make an incision on the external segment of the nasobiliary duct, positioned beyond the aperture of the primary duodenal papilla. Then extracting the severed nasobiliary duct and retaining the portion inside the duct.
DEVICE	Bilateral plastic stent	Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis

Timeline

• Start date: 2022-01-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-10-30
• Last updated: 2023-10-30

Locations

1 site across 1 country: China