search
Back to results

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

Primary Purpose

Acute Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
EUS-guided gallbladder drainage
Non EUS-guided gallbladder drainage
Sponsored by
Instituto Ecuatoriano de Enfermedades Digestivas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Cholecystitis focused on measuring endoscopic ultrasound, acute cholecystitis, cholangiocarcinoma, gallbladder drainage, metallic stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Ecuatoriano de Enfermedades Digestivas

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

EUS-guided gallbladder drainage

Non EUS-guided gallbladder drainage

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Technical success rate: EUS-GBD
as the ability of access and drain the gallbladder by placement of a drainage stent: lumen apposing metal stent ( Hot AXIOS™ Stent and Electrocautery Enhanced Delivered System; Boston Scientific Corporation, Natick, MA, USA).
Clinical success rate:
non-occurrence of acute cholecystitis during follow up OR successful SEMS placement with biliary decompression and relief of jaundice pruritus.
adverse events
any procedure-related adverse event (anesthesia, EUS-GBD, ERCP).
presence of pus during EUS-GBD
endoscopic visualization of pus after EUS-GBD. Yes or no.
Duration of the lumen apposing stent patency in the EUS-GBD arm study
Duration of the lumen apposing stent patency in the EUS-GBD arm study
Need for gallbladder re-intervention.
on EUS-GBD patients arm, need for a new gallbladder drainage (surgical or percutaneous) due to the occurrence of acute cholecystitis.
Total length of hospital stay
it will be measured on both arms study when patients require hospitalization due to any procedure adverse event, cholecystitis and related procedures (cholecystectomy, percutaneous drainage)
Total health-care related cost of both arm participants.
total health-are related cost in all participants from each arm.

Full Information

First Posted
July 21, 2018
Last Updated
July 27, 2020
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
search

1. Study Identification

Unique Protocol Identification Number
NCT03729882
Brief Title
Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
Official Title
Prophylactic Endoscopic Ultrasound Gallbladder Drainage (EUS-GBD) in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 27, 2019 (Actual)
Study Completion Date
July 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Endoscopic biliary drainage with a self-expandable metal stent (SEMS) is an accepted form of palliative therapy for distal malignant biliary obstruction (MBO); it is a low invasive procedure with a long-term patency. Covered SEMSs have a longer patency than uncovered SEMSs in patients with MBO, because covered SEMSs can prevent tumor ingrowth. However, complications of covered SEMSs include stent occlusion, migration, kinking, non-occlusion cholangitis, liver abscess, pancreatitis and cholecystitis. Nonsurgical decompression of the gallbladder is urgently needs to prevent sepsis, perforation and death in patients with acute cholecystitis. Several risk factors of cholecystitis after SEMS placement for distal MBO have been reported: however, tumor involvement to the orifice of the cystic duct (OCD) is the major predictive factor for cholecystitis after endoscopic SEMSs placement for distal MBO palliative treatment . Acute cholecystitis related to SEMSs deployment was evaluated in 2009, by using endoscopic trans-papillary gallbladder drainage (TPGBD) in 11 individuals in whom SEMSs covered the OCD. None episode of cholecystitis was reported, however TPGBD is a difficult technique with a high rate of stent dislodgement and reintervention needed. EUS-GBD by using a lumen apposing metal stent have been proposed, but only for acute cholecystitis treatment or symptomatic gallbladder hydrops, never as a prophylactic technique. The aim of this study if to determine if primary prophylaxis EUS-GBD in patients with distal malignant biliary obstruction and the OCD involvement is superior than conservative management. Also, a cost-effectiveness analysis will be done in both arm groups. This would be the first trial to study the effect of prophylactic EUS-GBD prior SEMSs deployment in patients with distal malignant biliary obstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
endoscopic ultrasound, acute cholecystitis, cholangiocarcinoma, gallbladder drainage, metallic stents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS-guided gallbladder drainage
Arm Type
Other
Arm 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.
Arm Title
Non EUS-guided gallbladder drainage
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
EUS-guided gallbladder drainage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non EUS-guided gallbladder drainage
Intervention Description
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
Primary Outcome Measure Information:
Title
Ocurrence of acute cholecystitis
Description
• 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).
Time Frame
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 Outcome Measure Information:
Title
Technical success rate: EUS-GBD
Description
as the ability of access and drain the gallbladder by placement of a drainage stent: lumen apposing metal stent ( Hot AXIOS™ Stent and Electrocautery Enhanced Delivered System; Boston Scientific Corporation, Natick, MA, USA).
Time Frame
from the beginning of the EUS-GBD procedure and 10 minutes after LAMS placement.
Title
Clinical success rate:
Description
non-occurrence of acute cholecystitis during follow up OR successful SEMS placement with biliary decompression and relief of jaundice pruritus.
Time Frame
since enrollment until 30-days follow up.
Title
adverse events
Description
any procedure-related adverse event (anesthesia, EUS-GBD, ERCP).
Time Frame
from the beginning of the procedure until 30 days.
Title
presence of pus during EUS-GBD
Description
endoscopic visualization of pus after EUS-GBD. Yes or no.
Time Frame
immediate after EUS-GBD.
Title
Duration of the lumen apposing stent patency in the EUS-GBD arm study
Description
Duration of the lumen apposing stent patency in the EUS-GBD arm study
Time Frame
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.
Title
Need for gallbladder re-intervention.
Description
on EUS-GBD patients arm, need for a new gallbladder drainage (surgical or percutaneous) due to the occurrence of acute cholecystitis.
Time Frame
from the end of the procedure until the date of first documented episode of acute cholecystitis through 12 months follow-up
Title
Total length of hospital stay
Description
it will be measured on both arms study when patients require hospitalization due to any procedure adverse event, cholecystitis and related procedures (cholecystectomy, percutaneous drainage)
Time Frame
from the beginning of hospitalization until discharge date or death since enrollment through 12 months follow-up
Title
Total health-care related cost of both arm participants.
Description
total health-are related cost in all participants from each arm.
Time Frame
from the end of conventional biliary drainage until the date of 12 months follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda
Organizational Affiliation
Instituto Ecuatoriano de Enfermedades Digestivas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Ecuatoriano de Enfermedades Digestivas
City
Guayaquil
State/Province
Guayas
ZIP/Postal Code
090505
Country
Ecuador

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19888656
Citation
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.
Results Reference
background
PubMed Identifier
24628054
Citation
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.
Results Reference
background
PubMed Identifier
16904950
Citation
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.
Results Reference
background
PubMed Identifier
23020651
Citation
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.
Results Reference
background
PubMed Identifier
26929775
Citation
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.
Results Reference
background
PubMed Identifier
28043931
Citation
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.
Results Reference
background
PubMed Identifier
27250045
Citation
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.
Results Reference
background
PubMed Identifier
27566055
Citation
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.
Results Reference
background
PubMed Identifier
28259594
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs