Malignant Biliary ObstructionNCT04898777
EUS-Guided Choledochoduodenostomy Versus ERCP for Primary Biliary Decompression in Distal Malignant Biliary Obstruction
A study testing Biliary drainage in people with Malignant Biliary Obstruction, run by Mansoura University at 1 site in Egypt.
Trial summary
Malignant biliary obstruction commonly caused by pancreatic adenocarcinoma, cholangiocarcinoma and other etiologies like gallbladder carcinoma, hepatocellular carcinoma, lymphoma, and metastasis to regional solid organs and lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- Biliary drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age: 18 years and older.
- Presence of locally advanced or metastatic pancreatic head mass on CT or magnetic resonance imaging of the abdomen
- Absence of duodenal obstruction.
- Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
- Histologic or cytologic diagnosis of malignancy.
- Accept sharing in the study.
Who cannot join
- Age younger than 18 years.
- Pregnancy.
- Hilar biliary obstruction (as the main lesion or coexisting with distal obstruction).
- Presence of duodenal obstruction.
- Histologic or cytologic diagnosis of malignancy.
- Patients underwent previous intervention for biliary drainage.
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- Previously failed biliary cannulation at ERCP.
- Prior biliary sphincterotomy or stent placement.
- Surgically altered anatomy or inability to access the major duodenal papilla.
- 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.
Egypt1 site
Specialized Medical Hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus Endoscopic Retrograde Cholangiopancreatography for Primary Biliary Decompression in Distal Malignant Biliary Obstruction
Malignant biliary obstruction commonly caused by pancreatic adenocarcinoma, cholangiocarcinoma and other etiologies like gallbladder carcinoma, hepatocellular carcinoma, lymphoma, and metastasis to regional solid organs and lymph nodes.
Pancreatobiliary cancers generally present with jaundice, weight loss, and anorexia with significant impact on quality of life, morbidity, and mortality.
Read more
The primary goal of diagnosis and management is curative resection but it's difficult due to local invasion and distant metastases at the time of clinical presentation. Biliary decompression helps to reduce symptoms and improve quality of life in patients with malignant biliary obstruction.
Endoscopically placed stents have become the standard of care for non-surgical biliary drainage due to their minimal invasiveness compared to percutaneous drainage.
The standard treatment of obstructive jaundice has been ERCP with biliary stent placement with high success rate in expert hands and low frequency of adverse events.
Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been increasingly used in patients who underwent failed ERCP. EUS-BD can be performed in several ways, choledochoduodenostomy (CDS), hepaticogastrostomy (HGS), antegrade (AG) procedure, and rendezvous (RV) technique.
Read the detailed description
This study will be a single center, prospective randomized comparative study that includes 50 patients with distal malignant biliary obstruction including pancreatic head masses, distal cholangiocarcinoma or papillary carcinoma.
All patients with inclusion criteria will be recruited in the study by simple random sampling using sealed envelopes until fulfillment of needed sample size for both EUS-BD arm and ERCP-BD arm.
Study tools:
- Informed consent will be obtained from each participant sharing in the study.
- Throughout history taking, complete general examination and local abdominal examination.
- Laboratory investigations: CBC, Serum creatinine, Liver functions tests (AST, ALT and Serum Albumin), Alkaline phosphatase, Serum bilirubin and INR.
- ERCP-BD by papillary approach and EUS-BD by choledochoduodenostomy with transmural stent placement.
- All procedures will be performed under deep sedation or general anesthesia in the left lateral position.
- Procedural time is recorded.
- Technical success is considered after stent placement (expanded and patent) with good bile flow and drainage.
- Follow up:
- Lab investigations will be requested at 2 days, 2 and 4 weeks, 3 and 6 months after the procedure including:
CBC, S.Cr, S.Bil, AST, ALT, S.Alb, ALP and INR.
- 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.
- Clinical success is considered at 2 weeks if total bilirubin is less than 50% of baseline and at 4 weeks if total bilirubin is less than 3mg/dL.
- Conditions
- Malignant Biliary Obstruction
- Being tested
- Biliary drainage
- Keywords
- ERCP, EUS, Distal Malignant Biliary Obstruction, Choledochoduodenostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary drainageProcedure or surgery
Also called Biliary Decompression
Biliary decompression in cases of distal malignant obstruction by stent placement either using ERCP or EUS.
| Study group | Role | What they receive |
|---|---|---|
| ERCP-BD | Active comparator | ERCP Biliary Drainage by papillary approach with stent placement. Receives: Procedure: Biliary drainage |
| EUS-BD | Active comparator | Endoscopic Ultrasound guided Biliary Drainage by Choledochoduodenostomy with transmural stent placement. Receives: Procedure: Biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of 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: 6 months
Secondary outcomes (4)
Rate of technical success
Technical success is considered after successful stent placement.
Measured: During procedure
Rate of clinical success
Clinical success is considered at 2 weeks if total bilirubin is less than 50 percent of baseline.
Measured: 4 weeks
Procedural duration
Procedure time was defined as time from biliary cannulation to stent placement in ERCP group, and time from needle puncture of the dilated bile duct to stent placement in EUS-BD group. In cases of difficult cannulation (defined as failed biliary access within 5 min of attempt), we performed early precut fistulotomy for cannulation by experts without involvement of trainees and duodenal intubation time was not included within procedure time.
Measured: During procedure
Reinterventions
Re-endoscopy in cases of stent migration, occlusion by food or tumor ingrowth.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary ObstructionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Gaheen, MSc., Principal investigator, Mansoura UniversityAhmed Y Altonbary, MD, Study director, Mansoura UniversityHazem H Alminshawy, Professor, Study director, Mansoura UniversityAhmed G Deiab, A.Professor, Study director, Mansoura UniversityMagdy H Atwa, Professor, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898777
- Sponsor's protocol ID
- MD.21.03.437
- Status last verified
- Oct 2023
- First submitted
- 5 May 2021
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus Endoscopic Retrograde Cholangiopancreatography for Primary Biliary Decompression in Distal Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT04898777
- Acronym / sponsor ID
- MD.21.03.437
- Conditions
- Malignant Biliary Obstruction
- Keywords
- ERCP, EUS, Distal Malignant Biliary Obstruction, Choledochoduodenostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 24 May 2021 (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.
Malignant biliary obstruction commonly caused by pancreatic adenocarcinoma, cholangiocarcinoma and other etiologies like gallbladder carcinoma, hepatocellular carcinoma, lymphoma, and metastasis to regional solid organs and lymph nodes.
Pancreatobiliary cancers generally present with jaundice, weight loss, and anorexia with significant impact on quality of life, morbidity, and mortality.
The primary goal of diagnosis and management is curative resection but it's difficult due to local invasion and distant metastases at the time of clinical presentation. Biliary decompression helps to reduce symptoms and improve quality of life in patients with malignant biliary obstruction.
Endoscopically placed stents have become the standard of care for non-surgical biliary drainage due to their minimal invasiveness compared to percutaneous drainage.
The standard treatment of obstructive jaundice has been ERCP with biliary stent placement with high success rate in expert hands and low frequency of adverse events.
Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been increasingly used in patients who underwent failed ERCP. EUS-BD can be performed in several ways, choledochoduodenostomy (CDS), hepaticogastrostomy (HGS), antegrade (AG) procedure, and rendezvous (RV) technique.
Detailed description
This study will be a single center, prospective randomized comparative study that includes 50 patients with distal malignant biliary obstruction including pancreatic head masses, distal cholangiocarcinoma or papillary carcinoma.
All patients with inclusion criteria will be recruited in the study by simple random sampling using sealed envelopes until fulfillment of needed sample size for both EUS-BD arm and ERCP-BD arm.
Study tools:
- Informed consent will be obtained from each participant sharing in the study.
- Throughout history taking, complete general examination and local abdominal examination.
- Laboratory investigations: CBC, Serum creatinine, Liver functions tests (AST, ALT and Serum Albumin), Alkaline phosphatase, Serum bilirubin and INR.
- ERCP-BD by papillary approach and EUS-BD by choledochoduodenostomy with transmural stent placement.
- All procedures will be performed under deep sedation or general anesthesia in the left lateral position.
- Procedural time is recorded.
- Technical success is considered after stent placement (expanded and patent) with good bile flow and drainage.
- Follow up:
- Lab investigations will be requested at 2 days, 2 and 4 weeks, 3 and 6 months after the procedure including:
CBC, S.Cr, S.Bil, AST, ALT, S.Alb, ALP and INR.
- 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.
- Clinical success is considered at 2 weeks if total bilirubin is less than 50% of baseline and at 4 weeks if total bilirubin is less than 3mg/dL.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP-BD | Active comparator | Procedure: Biliary drainageERCP Biliary Drainage by papillary approach with stent placement. |
| EUS-BD | Active comparator | Procedure: Biliary drainageEndoscopic Ultrasound guided Biliary Drainage by Choledochoduodenostomy with transmural stent placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 years and older.
- Presence of locally advanced or metastatic pancreatic head mass on CT or magnetic resonance imaging of the abdomen
- Absence of duodenal obstruction.
- Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
- Histologic or cytologic diagnosis of malignancy.
Key exclusion criteria (13 listed)
- Age younger than 18 years.
- Pregnancy.
- Hilar biliary obstruction (as the main lesion or coexisting with distal obstruction).
- Presence of duodenal obstruction.
- Histologic or cytologic diagnosis of malignancy.
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 |
|---|---|---|
| Biliary drainageAlso: Biliary DecompressionBiliary decompression in cases of distal malignant obstruction by stent placement either using ERCP or EUS. | Procedure or surgery | ERCP-BD, EUS-BD |
Primary outcome
The rate of adverse events
Time frame: 6 months
- 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
4 secondary outcomes
Rate of technical success
Time frame: During procedure
Rate of clinical success
Time frame: 4 weeks
Procedural duration
Time frame: During procedure
Reinterventions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Malignant Biliary Obstruction
Active, not recruitingObservational study
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Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)
Cholangiocarcinoma, Bile Duct Neoplasms
Recruiting
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Malignant Biliary Obstruction, Malignant Biliary Stricture
Not yet recruiting
Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Biliary Tract Neoplasms, Biliary Drainage
Active, not recruiting
Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
Pancreatic Cancer Non-resectable, Bile Duct 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. This study is not recruiting at the moment.
Ahmed M Gaheen, MSc. principal investigator
Mansoura University
Ahmed Y Altonbary, MD study director
Mansoura University
Hazem H Alminshawy, Professor study director
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 Biliary drainage in people with Malignant Biliary Obstruction, 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 6 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: finished, as of the sponsor's last update on 27 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of adverse events (time frame: 6 months). 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 27 Dec 2024.