Clinical trial NCT06613945: ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Official title: Endoscopic Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Hilar Stricture
Keywords: Malignant Hilar Biliary Obstruction
Endoscopic Retrograde Cholangiopancreatography
Endoscopic Ultrasound Guided Hepaticogastrostomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III \&amp; 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.

Primary outcomes:
measure: Technical success
timeFrame: during the procedure
measure: Procedural duration
timeFrame: at the end of the procedure
measure: Clinical success
timeFrame: 3 month
measure: Re-interventions
timeFrame: 3 month
Secondary outcomes:
measure: Adverse events
timeFrame: 3 month
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura univeristy
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mennatallah E saad, asslecturer
role: PRINCIPAL_INVESTIGATOR
References: