Clinical trial · Interventional
Endoscopic Ultrasonography Guided Biliary Drainage
Endoscopic Ultrasonography-Guided Biliary Drainage Versus Percutaneous Trans-hepatic Biliary Drainage for Malignant Biliary Obstruction After Failed Endoscopic Retrograde Cholangio-pancreaticography
NCT03195075CI-TRIAL-00028215unknownN/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)
Endoscopic ultrasonography is a widely accepted modality for the diagnosis of gastrointestinal and pancreatic-biliary diseases. Endoscopic ultrasonography-guided biliary drainage has attracted attention as an alternative procedure to percutaneous trans-hepatic biliary drainage, with a technical success between 75%-100% and with low complication rate. Other important advantage of endoscopic ultrasonography-guided biliary drainage compared with external percutaneous trans-hepatic biliary drainage is better quality of life due to the internal placement of the stent.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Hepatobiliary Neoplasm | Malignant Hepatobiliary Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic ultrasonography guided biliary drainage | Procedure | — | UNRESOLVED |
| Percutaneous trans-hepatic biliary drainage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- 20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography guided biliary drainage
- interventionNames
- Procedure: Endoscopic ultrasonography guided biliary drainage
- type
- ACTIVE_COMPARATOR
- label
- Group 2
- description
- 20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to percutaneous trans-hepatic biliary drainage.
- interventionNames
- Procedure: Percutaneous trans-hepatic biliary drainage
Primary outcomes (2)
- measure
- Laboratory evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Presence of un-resectable malignant distal biliary obstruction. 2. Failed conventional endoscopic retrograde cholangio-pancreaticography and inaccessible papilla because of accompanying duodenal obstruction, peri-ampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (Billroth II operation, Roux-an-Y operation). 3. Histological or cytological diagnosis of malignancy 4. No serious or uncontrolled medical illness Exclusion Criteria: 1. Patient age of less than 18 years 2. Uncorrectable coagulopathy 3. History of allergy to radio-contrast agents 4. Refusal to participate in this study 5. Severs co-existed cardiopulmonary and /or renal disease 6. Low platelet count (50000/μL) 7. Patients with disturbed conscious level
References
Publications (13)
- BACKGROUNDFerrucci JT Jr, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage: technique, results, and applications. Radiology. 1980 Apr;135(1):1-13. doi: 10.1148/radiology.135.1.7360943. PMID 7360943
- BACKGROUNDVilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. doi: 10.1016/s0016-5107(92)70385-x. No abstract available. PMID 1568614
- BACKGROUNDHanada K, Iiboshi T, Ishii Y. Endoscopic ultrasound-guided choledochoduodenostomy for palliative biliary drainage in cases with inoperable pancreas head carcinoma. Dig Endosc. 2009 Jul;21 Suppl 1:S75-8. doi: 10.1111/j.1443-1661.2009.00855.x. PMID 19691742
- BACKGROUNDCollins D, Penman I, Mishra G, Draganov P. EUS-guided celiac block and neurolysis. Endoscopy. 2006 Sep;38(9):935-9. doi: 10.1055/s-2006-944734. PMID 16981114
- BACKGROUNDvan der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230. PMID 20071702
- BACKGROUNDPuspok A, Lomoschitz F, Dejaco C, Hejna M, Sautner T, Gangl A. Endoscopic ultrasound guided therapy of benign and malignant biliary obstruction: a case series. Am J Gastroenterol. 2005 Aug;100(8):1743-7. doi: 10.1111/j.1572-0241.2005.41806.x. PMID 16086710
- BACKGROUNDShami VM, Kahaleh M. Endoscopic ultrasonography (EUS)-guided access and therapy of pancreatico-biliary disorders: EUS-guided cholangio and pancreatic drainage. Gastrointest Endosc Clin N Am. 2007 Jul;17(3):581-93, vii-viii. doi: 10.1016/j.giec.2007.05.015.