Clinical trial NCT03729882: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cholecystitis
Keywords: endoscopic ultrasound
acute cholecystitis
cholangiocarcinoma
gallbladder drainage
metallic stents
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Ocurrence of acute cholecystitis
timeFrame: 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:
measure: Technical success rate: EUS-GBD
timeFrame: from the beginning of the EUS-GBD procedure and 10 minutes after LAMS placement.
measure: Clinical success rate:
timeFrame: since enrollment until 30-days follow up.
measure: adverse events
timeFrame: from the beginning of the procedure until 30 days.
measure: presence of pus during EUS-GBD
timeFrame: immediate after EUS-GBD.
measure: Duration of the lumen apposing stent patency in the EUS-GBD arm study
timeFrame: 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.
measure: Need for gallbladder re-intervention.
timeFrame: from the end of the procedure until the date of first documented episode of acute cholecystitis through 12 months follow-up
measure: Total length of hospital stay
timeFrame: from the beginning of hospitalization until discharge date or death since enrollment through 12 months follow-up
measure: Total health-care related cost of both arm participants.
timeFrame: from the end of conventional biliary drainage until the date of 12 months follow-up.
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Instituto Ecuatoriano de Enfermedades Digestivas
state: Guayas
Study officials:
affiliation: Instituto Ecuatoriano de Enfermedades Digestivas
name: Carlos Robles-Medranda
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.
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.