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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasobiliary duct cutting | Experimental | 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 it. |
|
| Bilateral plastic stent | Active Comparator | Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic nasobiliary duct cutting | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of cholangitis | Cholangitis that occurred within 1 month after endoscopic retrograde cholangiopancreatography(ERCP). | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Re-intervention | Re-intervention was defined that endoscopic or percutaneous procedure to improve biliary drainage for jaundice or cholangitis after successful placement. | 6 month |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianfeng Yang, Doctor | Contact | (+86)13454132186 | yjf-1976@163.com, yjf3303@zju.edu.cn | |
| Wangyang Chen | Contact | (+86)18868108329 | 22118301@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianfeng Yang, Doctor | First People's Hospital of Hangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22895398 | Result | Kawashima H, Itoh A, Ohno E, Itoh Y, Ebata T, Nagino M, Goto H, Hirooka Y. Preoperative endoscopic nasobiliary drainage in 164 consecutive patients with suspected perihilar cholangiocarcinoma: a retrospective study of efficacy and risk factors related to complications. Ann Surg. 2013 Jan;257(1):121-7. doi: 10.1097/SLA.0b013e318262b2e9. | |
| 20700608 |
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|
| Bilateral plastic stent | Device | Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis |
|
ERCP-related adverse events
| 1 month |
| Kawakami H, Kuwatani M, Onodera M, Haba S, Eto K, Ehira N, Yamato H, Kudo T, Tanaka E, Hirano S, Kondo S, Asaka M. Endoscopic nasobiliary drainage is the most suitable preoperative biliary drainage method in the management of patients with hilar cholangiocarcinoma. J Gastroenterol. 2011 Feb;46(2):242-8. doi: 10.1007/s00535-010-0298-1. Epub 2010 Aug 11. |
| 33430020 | Result | Hakuta R, Kogure H, Nakai Y, Kawakami H, Maguchi H, Mukai T, Iwashita T, Saito T, Togawa O, Matsubara S, Hayashi T, Maetani I, Ito Y, Hasebe O, Itoi T, Hanada K, Isayama H. Unilateral versus Bilateral Endoscopic Nasobiliary Drainage and Subsequent Metal Stent Placement for Unresectable Malignant Hilar Obstruction: A Multicenter Randomized Controlled Trial. J Clin Med. 2021 Jan 8;10(2):206. doi: 10.3390/jcm10020206. |
| 35081535 | Result | Sugiura R, Kuwatani M, Hayashi T, Yoshida M, Ihara H, Yamato H, Onodera M, Katanuma A; Hokkaido Interventional EUS/ERCP study (HONEST) group. Endoscopic Nasobiliary Drainage Comparable with Endoscopic Biliary Stenting as a Preoperative Drainage Method for Malignant Hilar Biliary Obstruction: A Multicenter Retrospective Study. Digestion. 2022;103(3):205-216. doi: 10.1159/000521510. Epub 2022 Jan 26. |
| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| D005705 | Gallbladder Diseases |
| D001649 | Bile Duct Diseases |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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