Clinical trial · Interventional
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
NCT06106750CI-TRIAL-00070900unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Diseases | — | UNRESOLVED | — |
| Bile Duct Stenosis | — | UNRESOLVED | — |
| Biliary Disease | — | UNRESOLVED | — |
| Biliary Stricture | — | UNRESOLVED | — |
| Cholangiocarcinoma, Hilar | Hilar Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Hilar Cholangiocarcinoma | Hilar Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Klatskin Tumor | Hilar Cholangiocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bilateral plastic stent | Device | — | UNRESOLVED |
| Endoscopic nasobiliary duct cutting | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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 it.
- interventionNames
- Device: Endoscopic nasobiliary duct cutting
- type
- ACTIVE_COMPARATOR
- label
- Bilateral plastic stent
- description
- Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis
- interventionNames
- Device: Bilateral plastic stent
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTKawashima 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. PMID 22895398
- RESULTKawakami 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. PMID 20700608
- RESULTHakuta 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. PMID 33430020
- RESULTSugiura 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. PMID 35081535