Clinical trial · Interventional
Application of Endoscopic Scissors Cutting ENBD Tube in the Treatment of Malignant Hilar Biliary Strictures
Application of Endoscopic Scissors Cutting Endoscopic Nasobiliary Drainage Tube in the Treatment of Malignant Hilar Biliary Strictures: a Multicenter, Prospective, Randomized Controlled Study
NCT03353181CI-TRIAL-00060548ENBDwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failure to recruit patients
Summary
Brief summary (as posted)
The purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography | — | UNRESOLVED | — |
| Klatskin Tumor | Hilar Cholangiocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biliary stent | Device | — | UNRESOLVED |
| Endoscopic scissors | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic scissors
- description
- Endoscopic nasobiliary drainage for malignant hilar biliary strictures at first， and application of endoscopic cutting technique followed.
- interventionNames
- Device: Endoscopic scissors
- type
- ACTIVE_COMPARATOR
- label
- Stent
- description
- Standard placement of biliary stent for malignant hilar biliary strictures.
- interventionNames
- Device: Biliary stent
Primary outcomes (1)
- measure
- occurrence of acute cholangitis
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients age over 18 and able to tolerate ERCP. 2. Pathologically confirmed inoperable malignant hilar biliary strictures of Bismuth type II to IV. 3. No history of biliary tract surgery and first attempt at endoscopic or percutaneous drainage. 4. No acute cholangitis before ERCP. 5. Informed consent. Exclusion Criteria: 1. The patient is very ill(Septic shock, sepsis,coagulation disorders and so on) and cannot tolerate endoscopic treatment. 2. Previous biliary drainage procedure. 3. Inability to provide informed consent. 4. Participating in other clinical trials.
References
Publications (3)
- BACKGROUNDUchida N, Ezaki T, Fukuma H, Tsutsui K, Kobara H, Bang MH, Ogawa M, Watanabe K, Ono M, Morishita A, Ogi T, Kamata H, Masaki T, Watanabe S, Kuriyama S. Conversion of endoscopic nasobiliary drainage to internal drainage by means of endoscopic scissor forceps. Endoscopy. 2002 Feb;34(2):180. doi: 10.1055/s-2002-19841. No abstract available. PMID 11822021
- BACKGROUNDKawashima 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
- BACKGROUNDAsanuma Y, Andoh H, Tanaka J, Koyama K. [Biliary tract cancer]. Nihon Rinsho. 2001 Nov;59 Suppl 7:301-6. No abstract available. Japanese. PMID 11808135