Obstructive JaundiceNCT05246176
Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice
A study testing nephrostomy set in people with Obstructive Jaundice, run by Sohag University at 1 site in Egypt.
Trial summary
Obstructive jaundice may be of malignant and benign etiologies. Carcinoma of the gall bladder, cholangiocarcinoma, pancreatic adenocarcinoma, metastasis, and lymph nodal compression of common bile duct (CBD) constitute the majority of malignant causes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Jaundice
- What is being tested?
- nephrostomy set
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2021to 15 Aug 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult Patients with malignant obstructive jaundice will included in this study
Who cannot join
- Patients with bleeding diathesis.
- Patients with associating comorbidities.
- Patients with insufficient intrahepatic biliary dilatation < 0.5 cm or with extensive tumor infiltrates.
Trial locations and contacts
1 site in 1 country.
Medhat I Mohamed, ass. professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R ElSherif, professor
About this study
Official title: Role of Ultrasonography as a Single Tool for Guidance of Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice
Obstructive jaundice may be of malignant and benign etiologies. Carcinoma of the gall bladder, cholangiocarcinoma, pancreatic adenocarcinoma, metastasis, and lymph nodal compression of common bile duct (CBD) constitute the majority of malignant causes.
Most of the patients with malignant obstructive jaundice are already advanced and inoperable by the time they are diagnosed, hence carry bad prognosis with palliation being the only option left. Obstruction needs to be drained even in such cases for reducing pain, cholangitis, anorexia and pruritus as well as to reduce the serum bilirubin levels in certain cases to initiate chemo or intrabiliary brachytherapy.
Read more
Over the years, palliation has evolved with the introduction of newer methods and improvisation of existing techniques. Recent palliative measures prolong longevity and improve the quality of life, hence increasing the acceptance to such procedures; Methods of biliary drainage include: a. Surgical bypass b. Minimally invasive procedures; Endoscopic retrograde (ERCP) (cholangiopancreatography (ERCP), and Percutaneous transhepatic biliary drainage (PTBD).
ERCP as well as PTBD are well-established and effective means for biliary drainage as palliative treatment in unresectable cases.
With the current modern technique in experienced hands, Percutaneous Transhepatic Biliary Drainage (PTBD) equals endoscopic retrograde cholangio pancreatography (ERCP) regarding technical success and complications. In addition, there is a reduction in immediate procedure-related mortality with proven survival benefit. Moreover, it is the only immediate lifesaving procedure in cholangitis and sepsis.
- Conditions
- Obstructive Jaundice
- Being tested
- nephrostomy set
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nephrostomy setDevice
insertion of the nephrostomy set through the skin to obtaining good external drainage of bile in case of malignant obstructive jaundice.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | group of patient with inoperable malignant obstructive jaundice with failed internal drainage. Receives: Device: nephrostomy set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of hyperbilirubinemia.
We correct hyperbilirubinemia in patient with malignant obstructive jaundice using ultrasound to insert external drain.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start15 Jul 2021
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Aboelmakarem Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246176
- Sponsor's protocol ID
- Soh-Med-22-1-02
- Status last verified
- Feb 2022
- First submitted
- 12 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Venkatanarasimha N, Damodharan K, Gogna A, Leong S, Too CW, Patel A, Tay KH, Tan BS, Lo R, Irani F. Diagnosis and Management of Complications from Percutaneous Biliary Tract Interventions. Radiographics. 2017 Mar-Apr;37(2):665-680. doi: 10.1148/rg.2017160159.
PubMed 28287940Yarmohammadi H, Covey AM. Percutaneous biliary interventions and complications in malignant bile duct obstruction. Chin Clin Oncol. 2016 Oct;5(5):68. doi: 10.21037/cco.2016.10.07.
PubMed 27829281Gamanagatti S, Singh T, Sharma R, Srivastava DN, Dash NR, Garg PK. Unilobar Versus Bilobar Biliary Drainage: Effect on Quality of Life and Bilirubin Level Reduction. Indian J Palliat Care. 2016 Jan-Mar;22(1):50-62. doi: 10.4103/0973-1075.173958.
PubMed 26962281
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasonography as a Single Tool for Guidance of Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice
- ClinicalTrials.gov ID
- NCT05246176
- Acronym / sponsor ID
- Soh-Med-22-1-02
- Conditions
- Obstructive Jaundice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 18 Feb 2022 (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.
Obstructive jaundice may be of malignant and benign etiologies. Carcinoma of the gall bladder, cholangiocarcinoma, pancreatic adenocarcinoma, metastasis, and lymph nodal compression of common bile duct (CBD) constitute the majority of malignant causes.
Most of the patients with malignant obstructive jaundice are already advanced and inoperable by the time they are diagnosed, hence carry bad prognosis with palliation being the only option left. Obstruction needs to be drained even in such cases for reducing pain, cholangitis, anorexia and pruritus as well as to reduce the serum bilirubin levels in certain cases to initiate chemo or intrabiliary brachytherapy.
Over the years, palliation has evolved with the introduction of newer methods and improvisation of existing techniques. Recent palliative measures prolong longevity and improve the quality of life, hence increasing the acceptance to such procedures; Methods of biliary drainage include: a. Surgical bypass b. Minimally invasive procedures; Endoscopic retrograde (ERCP) (cholangiopancreatography (ERCP), and Percutaneous transhepatic biliary drainage (PTBD).
ERCP as well as PTBD are well-established and effective means for biliary drainage as palliative treatment in unresectable cases.
With the current modern technique in experienced hands, Percutaneous Transhepatic Biliary Drainage (PTBD) equals endoscopic retrograde cholangio pancreatography (ERCP) regarding technical success and complications. In addition, there is a reduction in immediate procedure-related mortality with proven survival benefit. Moreover, it is the only immediate lifesaving procedure in cholangitis and sepsis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Device: nephrostomy setgroup of patient with inoperable malignant obstructive jaundice with failed internal drainage. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult Patients with malignant obstructive jaundice will included in this study
Key exclusion criteria (3 listed)
- Patients with bleeding diathesis.
- Patients with associating comorbidities.
- Patients with insufficient intrahepatic biliary dilatation < 0.5 cm or with extensive tumor infiltrates.
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 |
|---|---|---|
| nephrostomy setinsertion of the nephrostomy set through the skin to obtaining good external drainage of bile in case of malignant obstructive jaundice. | Device | Cases |
Primary outcome
Correction of hyperbilirubinemia.
Time frame: 4 weeks
We correct hyperbilirubinemia in patient with malignant obstructive jaundice using ultrasound to insert external drain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 28287940Venkatanarasimha N, Damodharan K, Gogna A, Leong S, Too CW, Patel A, Tay KH, Tan BS, Lo R, Irani F. Diagnosis and Management of Complications from Percutaneous Biliary Tract Interventions. Radiographics. 2017 Mar-Apr;37(2):665-680. doi: 10.1148/rg.2017160159.
- Background: PubMed 27829281Yarmohammadi H, Covey AM. Percutaneous biliary interventions and complications in malignant bile duct obstruction. Chin Clin Oncol. 2016 Oct;5(5):68. doi: 10.21037/cco.2016.10.07.
- Background: PubMed 26962281Gamanagatti S, Singh T, Sharma R, Srivastava DN, Dash NR, Garg PK. Unilobar Versus Bilobar Biliary Drainage: Effect on Quality of Life and Bilirubin Level Reduction. Indian J Palliat Care. 2016 Jan-Mar;22(1):50-62. doi: 10.4103/0973-1075.173958.
- Individual participant dataSharing planned: Yes
Related trials for Obstructive Jaundice
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Not yet recruiting
Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Biliary Tract Neoplasms, Biliary Drainage
Not yet recruiting
Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice
Obstructive Jaundice, Pancreatic Head Cancer
Not yet recruiting
Determinants of Technical Success and Safety in Therapeutic ERCP for Obstructive Jaundice
Obstructive Jaundice, ERCP
Active, not recruiting
A RCT of Low MBO Drainage Strategies
Jaundice, Obstructive, Cholangiopancreatography, Endoscopic Retrograde
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.
Medhat I Mohamed, ass. professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nephrostomy set in people with Obstructive Jaundice, run by Sohag 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 1 inclusion and 3 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 18 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa A Ahmed, resident (01127688037, mostafa011186@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of hyperbilirubinemia. (time frame: 4 weeks). 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 NCT05246176, which also lists 3 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 18 Feb 2022.