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

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.

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.
    

Study Type

Interventional

Primary Outcome

Ocurrence of acute cholecystitis

Secondary Outcome

 Technical success rate: EUS-GBD

Condition

Acute Cholecystitis

Intervention

EUS-guided gallbladder drainage

Study Arms / Comparison Groups

 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

22

Start Date

July 1, 2018

Completion Date

July 27, 2020

Primary Completion Date

December 27, 2019

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Carlos Robles-Medranda, , 

Location Countries

Ecuador

Location Countries

Ecuador

NCT ID

NCT03729882

Organization ID

EUS-GBD

Responsible Party

Sponsor

Study Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Study Sponsor

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

Verification Date

July 2020