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Trial Title:
Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent
NCT ID:
NCT06106750
Condition:
Cholangiocarcinoma, Hilar
Biliary Stricture
Hilar Cholangiocarcinoma
Klatskin Tumor
Biliary Disease
Bile Duct Diseases
Bile Duct Stenosis
Conditions: Official terms:
Cholangiocarcinoma
Klatskin Tumor
Bile Duct Diseases
Gallbladder Diseases
Constriction, Pathologic
Conditions: Keywords:
Endoscopic Retrograde Cholangiopancreatography
Nasobiliary Duct
Stent
Endoscopic Drainage
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Endoscopic nasobiliary duct cutting
Description:
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.
Arm group label:
Nasobiliary duct cutting
Intervention type:
Device
Intervention name:
Bilateral plastic stent
Description:
Standard protocol for the placement of bilateral biliary plastic stents in the management
of malignant hilar biliary tract stenosis
Arm group label:
Bilateral plastic stent
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients over 18 years old and under 80 years old who were planned to carry out ERCP
for malignant hilar biliary duct stenosis
2. Clinically and pathologically confirmed malignant hilar biliary duct stenosis
3. MRCP determines Bismuth classification: II-IV type
4. Comply with research procedures and sign the informed consent form
Exclusion Criteria:
1. The patient has multiple organ dysfunction and cannot tolerate endoscopic treatment
2. The patient has undergone biliary drainage (endoscopic, percutaneous, or surgical)
3. The patient is currently suffering from cholangitis
4. The patient is participating in other clinical trials
5. Inability to provide informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hangzhou First People's Hospital
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianfeng Yang, Doctor
Phone:
(+86)13454132186
Email:
yjf-1976@163.com, yjf3303@zju.edu.cn
Contact backup:
Last name:
Wangyang Chen
Phone:
(+86)18868108329
Email:
22118301@zju.edu.cn
Start date:
January 1, 2022
Completion date:
January 1, 2026
Lead sponsor:
Agency:
First People's Hospital of Hangzhou
Agency class:
Other
Source:
First People's Hospital of Hangzhou
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06106750
