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

July 27, 2020 updated by: Instituto Ecuatoriano de Enfermedades Digestivas

Prophylactic Endoscopic Ultrasound Gallbladder Drainage (EUS-GBD) in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090505
        • Instituto Ecuatoriano de Enfermedades Digestivas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EUS-guided gallbladder drainage

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
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.
Procedure: Non EUS-guided gallbladder drainage
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
Other: Non EUS-guided gallbladder drainage

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocurrence of acute cholecystitis
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
• 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success rate: EUS-GBD
Time Frame: from the beginning of the EUS-GBD procedure and 10 minutes after LAMS placement.
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).
from the beginning of the EUS-GBD procedure and 10 minutes after LAMS placement.
Clinical success rate:
Time Frame: since enrollment until 30-days follow up.
non-occurrence of acute cholecystitis during follow up OR successful SEMS placement with biliary decompression and relief of jaundice pruritus.
since enrollment until 30-days follow up.
adverse events
Time Frame: from the beginning of the procedure until 30 days.
any procedure-related adverse event (anesthesia, EUS-GBD, ERCP).
from the beginning of the procedure until 30 days.
presence of pus during EUS-GBD
Time Frame: immediate after EUS-GBD.
endoscopic visualization of pus after EUS-GBD. Yes or no.
immediate after EUS-GBD.
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.
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.
Need for gallbladder re-intervention.
Time Frame: from the end of the procedure until the date of first documented episode of acute cholecystitis through 12 months follow-up
on EUS-GBD patients arm, need for a new gallbladder drainage (surgical or percutaneous) due to the occurrence of acute cholecystitis.
from the end of the procedure until the date of first documented episode of acute cholecystitis through 12 months follow-up
Total length of hospital stay
Time Frame: from the beginning of hospitalization until discharge date or death since enrollment through 12 months follow-up
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)
from the beginning of hospitalization until discharge date or death since enrollment through 12 months follow-up
Total health-care related cost of both arm participants.
Time Frame: from the end of conventional biliary drainage until the date of 12 months follow-up.
total health-are related cost in all participants from each arm.
from the end of conventional biliary drainage until the date of 12 months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Investigators

  • Principal Investigator: Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

December 27, 2019

Study Completion (Actual)

July 27, 2020

Study Registration Dates

First Submitted

July 21, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (Actual)

November 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUS-GBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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