Malignant Hilar Stricture
Conditions
Keywords
Malignant Hilar Biliary Obstruction, Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound Guided Hepaticogastrostomy
Brief summary
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
Detailed description
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
Interventions
PROCEDUREERCP biliary drainage
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
PROCEDURECombined ERCP and EUS-HGS 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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III & IV only. * Histologically confirmed malignant hilar biliary obstruction. * Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL). * Absence of duodenal narrowing/obstruction. * Accept sharing in the study
Exclusion criteria
* Pregnancy. * Distal biliary obstruction as the main lesion. * Benign biliary stenosis. * Malignant hilar biliary obstruction bismuth type I and II. * Presence of duodenal obstruction. * Surgically altered anatomy or inability to access the major duodenal papilla. * Patients underwent previous intervention for biliary drainage. * Previously failed biliary cannulation at ERCP. * Large volume ascites. * Patients unfit for anesthesia. * Patients having uncorrectable coagulopathy or thrombocytopenia. * History of allergy to radiocontrast agents. * Refuse sharing in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | during the procedure | considered after stent placement (expanded and patent) with good bile flow and drainage |
| Procedural duration | at the end of the procedure | 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 |
| Clinical success | 3 month | 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. |
| Re-interventions | 3 month | need for re-intervention to secure biliary drainage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 3 month | 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 |
Countries
Egypt
Contacts
Primary ContactMennatallah E Saad, Asslecturer
Backup ContactAhmed Y Altonbary, Assprofessor
Outcome results
None listed