Malignant Hilar StrictureNCT06613945
ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
A study testing ERCP biliary drainage and Combined ERCP and EUS-HGS biliary drainage in people with Malignant Hilar Stricture, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hilar Stricture
- What is being tested?
- ERCP biliary drainage and Combined ERCP and EUS-HGS biliary drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura univeristy
Al Mansurah, Dakahlia Governorate, 35511
Ahmed Y Altonbary, Assprofessor, +20 100 5100091 ext. +2, a.tonbary@gmail.com
Mennatallah E Saad, Asslecturer, +20 122 2449220 ext. +2, mennaehab@mans.edu.eg
About this study
Official title: Endoscopic Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
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
Read the 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
- Conditions
- Malignant Hilar Stricture
- Being tested
- ERCP biliary drainage, Combined ERCP and EUS-HGS biliary drainage
- Keywords
- Malignant Hilar Biliary Obstruction, Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound Guided Hepaticogastrostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP biliary drainageProcedure or surgery
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
Combined ERCP and EUS-HGS biliary drainageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined EUS-HGS and ERCP biliary drainage | Active comparator | unilateral metallic stent will be inserted on right side through ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage Receives: Procedure: Combined ERCP and EUS-HGS biliary drainage |
| ERCP biliary drainage | Active comparator | bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage Receives: Procedure: ERCP biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
considered after stent placement (expanded and patent) with good bile flow and drainage
Measured: 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
Measured: 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.
Measured: 3 month
Re-interventions
need for re-intervention to secure biliary drainage
Measured: 3 month
Secondary outcomes (1)
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
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Sep 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Hilar StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mennatallah E saad, asslecturer, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613945
- Sponsor's protocol ID
- MD.24.08.881
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the study just started recuriting and the decision to share will be decided when we have prelaminary satisfactory results
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
- ClinicalTrials.gov ID
- NCT06613945
- Acronym / sponsor ID
- MD.24.08.881
- Conditions
- Malignant Hilar Stricture
- Keywords
- Malignant Hilar Biliary Obstruction, Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound Guided Hepaticogastrostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined EUS-HGS and ERCP biliary drainage | Active comparator | Procedure: Combined ERCP and EUS-HGS biliary drainageunilateral metallic stent will be inserted on right side through ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage |
| ERCP biliary drainage | Active comparator | Procedure: ERCP biliary drainagebilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Pregnancy.
- Distal biliary obstruction as the main lesion.
- Benign biliary stenosis.
- Malignant hilar biliary obstruction bismuth type I and II.
- Presence of duodenal obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP biliary drainagebilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage | Procedure or surgery | ERCP biliary drainage |
| Combined ERCP and EUS-HGS biliary drainageunilateral 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. | Procedure or surgery | Combined EUS-HGS and ERCP biliary drainage |
Primary outcome
Technical success
Time frame: during the procedure
considered after stent placement (expanded and patent) with good bile flow and drainage
Procedural duration
Time frame: 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
Time frame: 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
Time frame: 3 month
need for re-intervention to secure biliary drainage
1 secondary outcome
Adverse events
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No. the study just started recuriting and the decision to share will be decided when we have prelaminary satisfactory results
Related trials for Malignant Hilar Stricture
Not yet recruiting
Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis
Biliary Disease Tract, Biliary Stenosis
Enrolling by invitationPhase 3
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction
Cholangiocarcinoma Non-resectable, Gall Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mennatallah E saad, asslecturer principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP biliary drainage and Combined ERCP and EUS-HGS biliary drainage in people with Malignant Hilar Stricture, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mennatallah E Saad, Asslecturer (0502200590 ext. 0502200590, mennaehab@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: during the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.