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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
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.
Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGThe occurrence of cholangitis
Cholangitis that occurred within 1 month after endoscopic retrograde cholangiopancreatography(ERCP).
Time frame: 1 month
Clinical success
Clinical success was defined that the decrease in the total bilirubin level to less than 50% of the pretreatment value within 1 week or to less than 75% within 1 month.
Time frame: 1 month
Re-intervention
Re-intervention was defined that endoscopic or percutaneous procedure to improve biliary drainage for jaundice or cholangitis after successful placement.
Time frame: 6 month
Adverse events
ERCP-related adverse events
Time frame: 1 month
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