Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.

NCT03729882 | Completed DMC

• 1 other identifier: EUS-GBD
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Cholecystitis

Keywords

endoscopic ultrasound; acute cholecystitis; cholangiocarcinoma; gallbladder drainage; metallic stents

Outcome Measures

Primary Outcomes (1)

• Ocurrence of acute cholecystitis

  • Occurrence of acute cholecystitis according to Tokyo guidelines 2013: Clinical symptoms showing right upper or epigastric pain or tenderness, signs of systematic inflammation (fever, elevated white blood cell count, and C-reactive protein), or positive findings on abdominal ultrasonography (US) or computed tomography (CT).

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcomes (8)

• Technical success rate: EUS-GBD

  from the beginning of the EUS-GBD procedure and 10 minutes after LAMS placement.

• Clinical success rate:

  since enrollment until 30-days follow up.

• adverse events

  from the beginning of the procedure until 30 days.

• presence of pus during EUS-GBD

  immediate after EUS-GBD.

• Duration of the lumen apposing stent patency in the EUS-GBD arm study

  the interval (days) between the time of stent placement and that of stent malfunction or patient death, whichever came first, assessed up to 12 months.

Study Arms (2)

EUS-guided gallbladder drainage

OTHER

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.

Procedure: EUS-guided gallbladder drainage; Procedure: Non EUS-guided gallbladder drainage

Non EUS-guided gallbladder drainage

OTHER

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.

Procedure: Non EUS-guided gallbladder drainage

Interventions

EUS-guided gallbladder drainage PROCEDURE

During ERCP evaluation a self-expandable metallic stent will be deployed in the common biliary duct of the patients enrolled in both arms of the present study. A prophylaxis gallbladder drainage will be done using a 3.8 mm working-channel linear-array therapeutic echoendoscope (EG3870UTK;Pentax, Hamburg, Germany) attached to an ultrasound console (Avius Hitachi, Tokyo, Japan) within a transgastric and/or transduodenal approaches to the gallbladder puncture followed by placement of a lumen apposing stent (LAMS) (AXIOS; Xlumena Inc, CA, USA) with a 10 mm luminal diameter and a dumbbell-shaped flanges to bring together the 2 walls in apposition. These feature of the Axios decrease the risk for bile leak, stent migration, and stent occlusion.

EUS-guided gallbladder drainage

Non EUS-guided gallbladder drainage PROCEDURE

During ERCP evaluation a self-expandable metallic stent will be deployed in the common biliary duct of the patients enrolled in both arms of the present study. If the patient had an acute cholecystitis will be sent to surgery and be considered as a Non EUS-guided gallbladder drainage

EUS-guided gallbladder drainage; Non EUS-guided gallbladder drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (9)

• Gosain 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 BACKGROUND

• Nakai 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 BACKGROUND

• Isayama 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 BACKGROUND

• Shimizu 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 BACKGROUND

• Xu MM, Kahaleh M. EUS-guided transmural gallbladder drainage: a new era has begun. Therap Adv Gastroenterol. 2016 Mar;9(2):138-40. doi: 10.1177/1756283X15618178. No abstract available.

  PMID: 26929775 BACKGROUND

• Irani 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.

  PMID: 28043931 BACKGROUND

• Hatanaka T, Itoi T, Ijima M, Matsui A, Kurihara E, Okuno N, Kobatake T, Kakizaki S, Yamada M. Efficacy and Safety of Endoscopic Gallbladder Stenting for Acute Cholecystitis in Patients with Concomitant Unresectable Cancer. Intern Med. 2016;55(11):1411-7. doi: 10.2169/internalmedicine.55.5820. Epub 2016 Jun 1.

  PMID: 27250045 BACKGROUND

• Choi JH, Kim HW, Lee JC, Paik KH, Seong NJ, Yoon CJ, Hwang JH, Kim J. Percutaneous transhepatic versus EUS-guided gallbladder drainage for malignant cystic duct obstruction. Gastrointest Endosc. 2017 Feb;85(2):357-364. doi: 10.1016/j.gie.2016.07.067. Epub 2016 Aug 24.

  PMID: 27566055 BACKGROUND

• Dollhopf M, Larghi A, Will U, Rimbas M, Anderloni A, Sanchez-Yague A, Teoh AYB, Kunda R. EUS-guided gallbladder drainage in patients with acute cholecystitis and high surgical risk using an electrocautery-enhanced lumen-apposing metal stent device. Gastrointest Endosc. 2017 Oct;86(4):636-643. doi: 10.1016/j.gie.2017.02.027. Epub 2017 Mar 1.

  PMID: 28259594 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Carlos Robles-Medranda

  Instituto Ecuatoriano de Enfermedades Digestivas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: November 5, 2018
• Study Start: July 1, 2018
• Primary Completion: December 27, 2019
• Study Completion: July 27, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)