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

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ClinicalTrials.gov Identifier: NCT03729882
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto Ecuatoriano de Enfermedades Digestivas

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).

Condition or disease Intervention/treatment Phase
Acute Cholecystitis Procedure: EUS-guided gallbladder drainage Procedure: Non EUS-guided gallbladder drainage Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Endoscopic Ultrasound Gallbladder Drainage (EUS-GBD) in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. adverse events [ Time Frame: from the beginning of the procedure until 30 days. ]
    any procedure-related adverse event (anesthesia, EUS-GBD, ERCP).

  4. presence of pus during EUS-GBD [ Time Frame: immediate after EUS-GBD. ]
    endoscopic visualization of pus after EUS-GBD. Yes or no.

  5. 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

  6. 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.

  7. 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)

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729882


Contacts
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Contact: Carlos Robles-Medranda, M.D. 0989158865 carlosoakm@yahoo.es

Locations
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Ecuador
Instituto Ecuatoriano de Enfermedades Digestivas Recruiting
Guayaquil, Guayas, Ecuador, 090505
Contact: Carlos Robles-Medranda    0989158865    carlosoakm@yahoo.es   
Principal Investigator: Carlos Robles-Medranda, M.D         
Sponsors and Collaborators
Instituto Ecuatoriano de Enfermedades Digestivas
Investigators
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Principal Investigator: Carlos Robles-Medranda Instituto Ecuatoriano de Enfermedades Digestivas

Publications:

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Responsible Party: Instituto Ecuatoriano de Enfermedades Digestivas
ClinicalTrials.gov Identifier: NCT03729882     History of Changes
Other Study ID Numbers: EUS-GBD
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Instituto Ecuatoriano de Enfermedades Digestivas:
endoscopic ultrasound
acute cholecystitis
cholangiocarcinoma
gallbladder drainage
metallic stents

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases