Malignant Hepatobiliary NeoplasmNCT03195075
Endoscopic Ultrasonography Guided Biliary Drainage
A study testing Endoscopic ultrasonography guided biliary drainage and Percutaneous trans-hepatic biliary drainage in people with Malignant Hepatobiliary Neoplasm, run by Assiut University.
Trial summary
Endoscopic ultrasonography is a widely accepted modality for the diagnosis of gastrointestinal and pancreatic-biliary diseases. Endoscopic ultrasonography-guided biliary drainage has attracted attention as an alternative procedure to percutaneous trans-hepatic biliary drainage, with a technical success between… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Hepatobiliary Neoplasm
- What is being tested?
- Endoscopic ultrasonography guided biliary drainage and Percutaneous trans-hepatic biliary drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Sep 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of un-resectable malignant distal biliary obstruction.
- Failed conventional endoscopic retrograde cholangio-pancreaticography and inaccessible papilla because of accompanying duodenal obstruction, peri-ampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (Billroth II operation, Roux-an-Y operation).
- Histological or cytological diagnosis of malignancy
- No serious or uncontrolled medical illness
Who cannot join
- Patient age of less than 18 years
- Uncorrectable coagulopathy
- History of allergy to radio-contrast agents
- Refusal to participate in this study
- Severs co-existed cardiopulmonary and /or renal disease
- Low platelet count (50000/μL)
- Patients with disturbed conscious level
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endoscopic Ultrasonography-Guided Biliary Drainage Versus Percutaneous Trans-hepatic Biliary Drainage for Malignant Biliary Obstruction After Failed Endoscopic Retrograde Cholangio-pancreaticography
Endoscopic ultrasonography is a widely accepted modality for the diagnosis of gastrointestinal and pancreatic-biliary diseases.
Endoscopic ultrasonography-guided biliary drainage has attracted attention as an alternative procedure to percutaneous trans-hepatic biliary drainage, with a technical success between 75%-100% and with low complication rate. Other important advantage of endoscopic ultrasonography-guided biliary drainage compared with external percutaneous trans-hepatic biliary drainage is better quality of life due to the internal placement of the stent.
Read the detailed description
If endoscopic retrograde cholangio-pancreaticography fails to achieve biliary drainage, more invasive options are usually considered. These include percutaneous trans-hepatic biliary drainage and surgical intervention but they have been associated with a higher risk of complications and prolonged hospital stay.
Some disadvantages with the percutaneous approach include the need to traverse the liver, a decreased quality of life due to the presence of external drainage and a significant morbidity and mortality, 7% and 5% respectively.
The external drainage of percutaneous trans-hepatic biliary drainage may add to the patient's burden owing to the cosmetic problem, skin inflammation or pain, or bile leakage, compromising the quality of life. From this point, the internal drainage of endoscopic ultrasonography-guided biliary drainage eliminates several issues.
Endoscopic ultrasonography-guided biliary drainage using a metal stent, particularly a lumen-apposing metal stent, can also be performed in patients with a large amount of ascites, which is often contraindicated in percutaneous trans-hepatic biliary drainage. Endoscopic ultrasonography-guided biliary drainage performed in the same session of the failed endoscopic retrograde cholangio-pancreaticography, in the same room and under the same sedation.
On the other hand, the endoscopic ultrasonography-guided biliary drainage, has major limitation due to fewer cases reported till date and lack of long term data. Because of, the technical difficulty encountered during re-intervention and problem of stent migration, the expertise needed for such procedure is a major limitation of the techniques.
Furthermore, comparative studies of endoscopic ultrasonography-guided biliary drainage versus percutaneous trans-hepatic biliary drainage are required to select the optimal candidates and to best evaluate the technical and treatment outcomes also in terms of quality of life and costs. Recently, Endoscopic ultrasonography-guided biliary drainage has been introduced as an alternative for patients who had failed endoscopic retrograde cholangio-pancreaticography.
Indications for endoscopic ultrasonography-guided biliary drainage:
- Failed conventional endoscopic retrograde cholangio-pancreaticography.
- Altered anatomy
- Tumor preventing access into the biliary tree
- Prior surgical procedure
- Biliary sphincter stenosis
- Contra-indication to percutaneous access
- Conditions
- Malignant Hepatobiliary Neoplasm
- Being tested
- Endoscopic ultrasonography guided biliary drainage, Percutaneous trans-hepatic biliary drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasonography guided biliary drainageProcedure or surgery
Endoscopic ultrasonography guided biliary drainage includes rendezvous techniques, endoscopic ultrasonography guided choledochoduodenostomy, and endoscopic ultrasonography-guided hepatogastrostomy using self-expandable metal stent will be done for group 1
Percutaneous trans-hepatic biliary drainageProcedure or surgery
Percutaneous trans-hepatic biliary drainage in interventional radiology department using self-expandable metal stent will be done for group 2
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography guided biliary drainage Receives: Procedure: Endoscopic ultrasonography guided biliary drainage |
| Group 2 | Active comparator | 20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to percutaneous trans-hepatic biliary drainage. Receives: Procedure: Percutaneous trans-hepatic biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction.
Evaluation of serum bilirubin and alkaline phosphatase by liver function test before and after the procedures
Measured: Liver function test before the procedure and follow up changes after one week from procedures.
Radiological evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction
Evaluation of biliary dilation by abdominal ultrasonography before and after the procedures,
Measured: Biliary dilation before the procedures and follow up changes after one week from procedures.
Secondary outcomes (1)
Evaluation of post-procedural complications
Evaluation of biliary leakage by ultrasound, hemorrhage by hemoglobin level, perforation and stent potency.
Measured: Within six months from procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startJan 2018 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Malignant Hepatobiliary NeoplasmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Model description
- This study will include 40 consecutive jaundiced patients with distal malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography. Twenty patients with failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography-guided biliary drainage will be performed by single endoscopist and another 20 patients with failed endoscopic retrograde cholangio-pancreaticography for percutaneous trans-hepatic biliary drainage.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelhamed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195075
- Sponsor's protocol ID
- EUS
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferrucci JT Jr, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage: technique, results, and applications. Radiology. 1980 Apr;135(1):1-13. doi: 10.1148/radiology.135.1.7360943.
PubMed 7360943Vilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. doi: 10.1016/s0016-5107(92)70385-x. No abstract available.
PubMed 1568614Hanada K, Iiboshi T, Ishii Y. Endoscopic ultrasound-guided choledochoduodenostomy for palliative biliary drainage in cases with inoperable pancreas head carcinoma. Dig Endosc. 2009 Jul;21 Suppl 1:S75-8. doi: 10.1111/j.1443-1661.2009.00855.x.
PubMed 19691742Collins D, Penman I, Mishra G, Draganov P. EUS-guided celiac block and neurolysis. Endoscopy. 2006 Sep;38(9):935-9. doi: 10.1055/s-2006-944734.
PubMed 16981114van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.
PubMed 20071702Puspok A, Lomoschitz F, Dejaco C, Hejna M, Sautner T, Gangl A. Endoscopic ultrasound guided therapy of benign and malignant biliary obstruction: a case series. Am J Gastroenterol. 2005 Aug;100(8):1743-7. doi: 10.1111/j.1572-0241.2005.41806.x.
PubMed 16086710Shami VM, Kahaleh M. Endoscopic ultrasonography (EUS)-guided access and therapy of pancreatico-biliary disorders: EUS-guided cholangio and pancreatic drainage. Gastrointest Endosc Clin N Am. 2007 Jul;17(3):581-93, vii-viii. doi: 10.1016/j.giec.2007.05.015.
PubMed 17640584Fabbri C, Luigiano C, Lisotti A, Cennamo V, Virgilio C, Caletti G, Fusaroli P. Endoscopic ultrasound-guided treatments: are we getting evidence based--a systematic review. World J Gastroenterol. 2014 Jul 14;20(26):8424-48. doi: 10.3748/wjg.v20.i26.8424.
PubMed 25024600Mallery S, Matlock J, Freeman ML. EUS-guided rendezvous drainage of obstructed biliary and pancreatic ducts: Report of 6 cases. Gastrointest Endosc. 2004 Jan;59(1):100-7. doi: 10.1016/s0016-5107(03)02300-9.
PubMed 14722561Kim YS, Gupta K, Mallery S, Li R, Kinney T, Freeman ML. Endoscopic ultrasound rendezvous for bile duct access using a transduodenal approach: cumulative experience at a single center. A case series. Endoscopy. 2010 Jun;42(6):496-502. doi: 10.1055/s-0029-1244082. Epub 2010 Apr 23.
PubMed 20419625Artifon EL, Ferreira FC, Otoch JP, Rasslan S, Itoi T, Perez-Miranda M. EUS-guided biliary drainage: a review article. JOP. 2012 Jan 10;13(1):7-17.
PubMed 22233941Artifon EL, Okawa L, Takada J, Gupta K, Moura EG, Sakai P. EUS-guided choledochoantrostomy: an alternative for biliary drainage in unresectable pancreatic cancer with duodenal invasion. Gastrointest Endosc. 2011 Jun;73(6):1317-20. doi: 10.1016/j.gie.2010.10.041. Epub 2010 Dec 31. No abstract available.
PubMed 21195404Burmester E, Niehaus J, Leineweber T, Huetteroth T. EUS-cholangio-drainage of the bile duct: report of 4 cases. Gastrointest Endosc. 2003 Feb;57(2):246-51. doi: 10.1067/mge.2003.85.
PubMed 12556796
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasonography-Guided Biliary Drainage Versus Percutaneous Trans-hepatic Biliary Drainage for Malignant Biliary Obstruction After Failed Endoscopic Retrograde Cholangio-pancreaticography
- ClinicalTrials.gov ID
- NCT03195075
- Acronym / sponsor ID
- EUS
- Conditions
- Malignant Hepatobiliary Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 22 Jun 2017 (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.
Endoscopic ultrasonography is a widely accepted modality for the diagnosis of gastrointestinal and pancreatic-biliary diseases.
Endoscopic ultrasonography-guided biliary drainage has attracted attention as an alternative procedure to percutaneous trans-hepatic biliary drainage, with a technical success between 75%-100% and with low complication rate. Other important advantage of endoscopic ultrasonography-guided biliary drainage compared with external percutaneous trans-hepatic biliary drainage is better quality of life due to the internal placement of the stent.
Detailed description
If endoscopic retrograde cholangio-pancreaticography fails to achieve biliary drainage, more invasive options are usually considered. These include percutaneous trans-hepatic biliary drainage and surgical intervention but they have been associated with a higher risk of complications and prolonged hospital stay.
Some disadvantages with the percutaneous approach include the need to traverse the liver, a decreased quality of life due to the presence of external drainage and a significant morbidity and mortality, 7% and 5% respectively.
The external drainage of percutaneous trans-hepatic biliary drainage may add to the patient's burden owing to the cosmetic problem, skin inflammation or pain, or bile leakage, compromising the quality of life. From this point, the internal drainage of endoscopic ultrasonography-guided biliary drainage eliminates several issues.
Endoscopic ultrasonography-guided biliary drainage using a metal stent, particularly a lumen-apposing metal stent, can also be performed in patients with a large amount of ascites, which is often contraindicated in percutaneous trans-hepatic biliary drainage. Endoscopic ultrasonography-guided biliary drainage performed in the same session of the failed endoscopic retrograde cholangio-pancreaticography, in the same room and under the same sedation.
On the other hand, the endoscopic ultrasonography-guided biliary drainage, has major limitation due to fewer cases reported till date and lack of long term data. Because of, the technical difficulty encountered during re-intervention and problem of stent migration, the expertise needed for such procedure is a major limitation of the techniques.
Furthermore, comparative studies of endoscopic ultrasonography-guided biliary drainage versus percutaneous trans-hepatic biliary drainage are required to select the optimal candidates and to best evaluate the technical and treatment outcomes also in terms of quality of life and costs. Recently, Endoscopic ultrasonography-guided biliary drainage has been introduced as an alternative for patients who had failed endoscopic retrograde cholangio-pancreaticography.
Indications for endoscopic ultrasonography-guided biliary drainage:
- Failed conventional endoscopic retrograde cholangio-pancreaticography.
- Altered anatomy
- Tumor preventing access into the biliary tree
- Prior surgical procedure
- Biliary sphincter stenosis
- Contra-indication to percutaneous access
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will include 40 consecutive jaundiced patients with distal malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography. Twenty patients with failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography-guided biliary drainage will be performed by single endoscopist and another 20 patients with failed endoscopic retrograde cholangio-pancreaticography for percutaneous trans-hepatic biliary drainage.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Endoscopic ultrasonography guided biliary drainage20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography guided biliary drainage |
| Group 2 | Active comparator | Procedure: Percutaneous trans-hepatic biliary drainage20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to percutaneous trans-hepatic biliary drainage. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of un-resectable malignant distal biliary obstruction.
- Failed conventional endoscopic retrograde cholangio-pancreaticography and inaccessible papilla because of accompanying duodenal obstruction, peri-ampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (Billroth II operation, Roux-an-Y operation).
- Histological or cytological diagnosis of malignancy
- No serious or uncontrolled medical illness
Key exclusion criteria (7 listed)
- Patient age of less than 18 years
- Uncorrectable coagulopathy
- History of allergy to radio-contrast agents
- Refusal to participate in this study
- Severs co-existed cardiopulmonary and /or renal disease
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 |
|---|---|---|
| Endoscopic ultrasonography guided biliary drainageEndoscopic ultrasonography guided biliary drainage includes rendezvous techniques, endoscopic ultrasonography guided choledochoduodenostomy, and endoscopic ultrasonography-guided hepatogastrostomy using self-expandable metal stent will be done for group 1 | Procedure or surgery | Group 1 |
| Percutaneous trans-hepatic biliary drainagePercutaneous trans-hepatic biliary drainage in interventional radiology department using self-expandable metal stent will be done for group 2 | Procedure or surgery | Group 2 |
Primary outcome
Laboratory evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction.
Time frame: Liver function test before the procedure and follow up changes after one week from procedures.
Evaluation of serum bilirubin and alkaline phosphatase by liver function test before and after the procedures
Radiological evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction
Time frame: Biliary dilation before the procedures and follow up changes after one week from procedures.
Evaluation of biliary dilation by abdominal ultrasonography before and after the procedures,
1 secondary outcome
Evaluation of post-procedural complications
Time frame: Within six months from procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Background: PubMed 7360943Ferrucci JT Jr, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage: technique, results, and applications. Radiology. 1980 Apr;135(1):1-13. doi: 10.1148/radiology.135.1.7360943.
- Background: PubMed 1568614Vilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. doi: 10.1016/s0016-5107(92)70385-x. No abstract available.
- Background: PubMed 19691742Hanada K, Iiboshi T, Ishii Y. Endoscopic ultrasound-guided choledochoduodenostomy for palliative biliary drainage in cases with inoperable pancreas head carcinoma. Dig Endosc. 2009 Jul;21 Suppl 1:S75-8. doi: 10.1111/j.1443-1661.2009.00855.x.
- Background: PubMed 16981114Collins D, Penman I, Mishra G, Draganov P. EUS-guided celiac block and neurolysis. Endoscopy. 2006 Sep;38(9):935-9. doi: 10.1055/s-2006-944734.
- Background: PubMed 20071702van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.
- Background: PubMed 16086710Puspok A, Lomoschitz F, Dejaco C, Hejna M, Sautner T, Gangl A. Endoscopic ultrasound guided therapy of benign and malignant biliary obstruction: a case series. Am J Gastroenterol. 2005 Aug;100(8):1743-7. doi: 10.1111/j.1572-0241.2005.41806.x.
- Background: PubMed 17640584Shami VM, Kahaleh M. Endoscopic ultrasonography (EUS)-guided access and therapy of pancreatico-biliary disorders: EUS-guided cholangio and pancreatic drainage. Gastrointest Endosc Clin N Am. 2007 Jul;17(3):581-93, vii-viii. doi: 10.1016/j.giec.2007.05.015.
- Background: PubMed 25024600Fabbri C, Luigiano C, Lisotti A, Cennamo V, Virgilio C, Caletti G, Fusaroli P. Endoscopic ultrasound-guided treatments: are we getting evidence based--a systematic review. World J Gastroenterol. 2014 Jul 14;20(26):8424-48. doi: 10.3748/wjg.v20.i26.8424.
- Background: PubMed 14722561Mallery S, Matlock J, Freeman ML. EUS-guided rendezvous drainage of obstructed biliary and pancreatic ducts: Report of 6 cases. Gastrointest Endosc. 2004 Jan;59(1):100-7. doi: 10.1016/s0016-5107(03)02300-9.
- Background: PubMed 20419625Kim YS, Gupta K, Mallery S, Li R, Kinney T, Freeman ML. Endoscopic ultrasound rendezvous for bile duct access using a transduodenal approach: cumulative experience at a single center. A case series. Endoscopy. 2010 Jun;42(6):496-502. doi: 10.1055/s-0029-1244082. Epub 2010 Apr 23.
- Background: PubMed 22233941Artifon EL, Ferreira FC, Otoch JP, Rasslan S, Itoi T, Perez-Miranda M. EUS-guided biliary drainage: a review article. JOP. 2012 Jan 10;13(1):7-17.
- Background: PubMed 21195404Artifon EL, Okawa L, Takada J, Gupta K, Moura EG, Sakai P. EUS-guided choledochoantrostomy: an alternative for biliary drainage in unresectable pancreatic cancer with duodenal invasion. Gastrointest Endosc. 2011 Jun;73(6):1317-20. doi: 10.1016/j.gie.2010.10.041. Epub 2010 Dec 31. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasonography guided biliary drainage and Percutaneous trans-hepatic biliary drainage in people with Malignant Hepatobiliary Neoplasm, run by Assiut University.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed El-Yamany, MD (01002228914, elyamany72@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction. (time frame: Liver function test before the procedure and follow up changes after one week from procedures.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195075, which also lists 13 linked publications.
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 22 Jun 2017.