A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions. Secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals
Bilateral stenting by Endoscopic Retrograde Cholangiopancreatography in malignant hilar biliary obstructions (MHBO) is challenging and technically difficult. EUS hepaticogastrostomy (EUS-HGS) has been increasingly used as an alternative method to achieve internal biliary drainage in MHBO. Because of the difficulty of ERCP in such scenario, the combination of EUS-HGS and ERCP provides a possible chance of longer stent patency with less event of stent clogging Aim of the work: to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced MHBO. The inclusion criteria will be presence of inoperable MHBO with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal The study patients will be randomized in 1:1 ratio to: ERCP biliary drainage (ERCP-BD) group: bilateral metallic stents insertion will be attempted by transpapilary approach. Combined ERCP and EUS-HGS group: unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by EUS. technical success, clinical success, procedural duration, and re-interventions and adverse events will be assesed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
unilateral metallic stent will be inserted on right side by ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage.
Mansoura univeristy
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGTechnical success
considered after stent placement (expanded and patent) with good bile flow and drainage
Time frame: during the procedure
Procedural duration
defined as time from biliary cannulation to stent placement by ERCP, and time from needle puncture of the dilated bile duct to stent placement by EUS
Time frame: at the end of the procedure
Clinical success
considered at 2 weeks by a 50% decrease in total bilirubin levels from baseline and at 4 weeks if total bilirubin is less than 3mg/dL.
Time frame: 3 month
Re-interventions
need for re-intervention to secure biliary drainage
Time frame: 3 month
Adverse events
Early adverse events (within 48 hours after procedure) including: pancreatitis, cholangitis, bleeding, perforation and peritonitis. \- Late adverse events include stent dysfunction either due to food impaction, tumor ingrowth or stent migration
Time frame: 3 month
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