Clinical trial · Interventional
Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
Prophylactic Endoscopic Ultrasound Gallbladder Drainage (EUS-GBD) in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
NCT03729882CI-TRIAL-00046231completedN/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)
to determine if primary prophylaxis with Endoscopic Ultrasound-Gallbladder Drainage (EUS-GBD) in unresectable cancer patients with the orifice of the cystic duct (OCD) involvement is superior to conservative management (Non EUS-guided gallbladder drainage).
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 |
|---|---|---|---|
| Acute Cholecystitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided gallbladder drainage | Procedure | — | UNRESOLVED |
| Non EUS-guided gallbladder drainage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- EUS-guided gallbladder drainage
- description
- In one arm, Endoscopic Ultrasound-Gallbladder Drainage (EUS-GBD) will be performed by using a 3,8 mm therapeutic echoendoscope and a lumen apposing metal stent ( Hot AXIOS™ Stent and Electrocautery Enhanced Delivered System; Boston Scientific Corporation, Natick, MA, USA) after conventional biliary drainage with self-expandable metallic stents during endoscopic retrograde cholangiopancreatography (ERCP). All procedures will be performed under general anesthesia.
- interventionNames
- Procedure: EUS-guided gallbladder drainage
- Procedure: Non EUS-guided gallbladder drainage
- type
- OTHER
- label
- Non EUS-guided gallbladder drainage
- description
- In the other arm, patients will undergo conventional biliary drainage with self-expandable metallic stent placement during ERCP evaluation without prophylactic EUS-GBD and will be considered as a Non EUS-guided gallbladder drainage. All procedures will be performed under general anesthesia.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Above 18 years old. * Obtained written consent for procedures * Unresectable malignant biliary obstruction diagnosed by Endoscopic Ultrasound and confirmed by confocal laser endomicroscopy (CLE) during cholangioscopy and histopathology. * Tumor involvement to the orifice of the cystic duct. * Self-expandable metallic plastic stent deployment as palliative therapy for distal biliary obstruction. Exclusion Criteria: * Under 18 years old. * Refuse to sign written informed consent. * Pregnancy * Previous cholecystectomy * Acute cholecystitis prior enrollment * Severe ascites that increases the distance between gastric or duodenal and gallbladder walls. * Large vessel between the gallbladder and gastric-duodenal wall. * Coagulopathy * Intrahepatic cholangiocarcinoma * Previous gallbladder drainage by percutaneous or endoscopic techniques.
References
Publications (9)
- BACKGROUNDGosain S, Bonatti H, Smith L, Rehan ME, Brock A, Mahajan A, Phillips M, Ho HC, Ellen K, Shami VM, Kahaleh M. Gallbladder stent placement for prevention of cholecystitis in patients receiving covered metal stent for malignant obstructive jaundice: a feasibility study. Dig Dis Sci. 2010 Aug;55(8):2406-11. doi: 10.1007/s10620-009-1024-9. Epub 2009 Nov 4. PMID 19888656
- BACKGROUNDNakai Y, Isayama H, Kawakubo K, Kogure H, Hamada T, Togawa O, Ito Y, Matsubara S, Arizumi T, Yagioka H, Takahara N, Uchino R, Mizuno S, Miyabayashi K, Yamamoto K, Sasaki T, Yamamoto N, Hirano K, Tada M, Koike K. Metallic stent with high axial force as a risk factor for cholecystitis in distal malignant biliary obstruction. J Gastroenterol Hepatol. 2014;29(7):1557-62. doi: 10.1111/jgh.12582. PMID 24628054
- BACKGROUNDIsayama H, Kawabe T, Nakai Y, Tsujino T, Sasahira N, Yamamoto N, Arizumi T, Togawa O, Matsubara S, Ito Y, Sasaki T, Hirano K, Toda N, Komatsu Y, Tada M, Yoshida H, Omata M. Cholecystitis after metallic stent placement in patients with malignant distal biliary obstruction. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1148-53. doi: 10.1016/j.cgh.2006.06.004. Epub 2006 Aug 14. PMID 16904950
- BACKGROUNDShimizu S, Naitoh I, Nakazawa T, Hayashi K, Miyabe K, Kondo H, Yoshida M, Yamashita H, Umemura S, Hori Y, Ohara H, Joh T. Predictive factors for pancreatitis and cholecystitis in endoscopic covered metal stenting for distal malignant biliary obstruction. J Gastroenterol Hepatol. 2013 Jan;28(1):68-72. doi: 10.1111/j.1440-1746.2012.07283.x. PMID 23020651
- BACKGROUNDXu MM, Kahaleh M. EUS-guided transmural gallbladder drainage: a new era has begun. Ther Adv Gastroenterol. 2016 Mar;9(2):138-40. doi: 10.1177/1756283X15618178. No abstract available. PMID 26929775
- BACKGROUNDIrani S, Ngamruengphong S, Teoh A, Will U, Nieto J, Abu Dayyeh BK, Gan SI, Larsen M, Yip HC, Topazian MD, Levy MJ, Thompson CC, Storm AC, Hajiyeva G, Ismail A, Chen YI, Bukhari M, Chavez YH, Kumbhari V, Khashab MA. Similar Efficacies of Endoscopic Ultrasound Gallbladder Drainage With a Lumen-Apposing Metal Stent Versus Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis. Clin Gastroenterol Hepatol. 2017 May;15(5):738-745. doi: 10.1016/j.cgh.2016.12.021. Epub 2016 Dec 30.