Extrahepatic CholestasisTransHepaticNCT05268731
Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures
An observational study of Extrahepatic Cholestasis, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
Trial summary
The clinical success of percutaneous transhepatic biliary drainage procedures (PTBDs) is usually measured by the the decrease of the serum bilirubin value. However, the bilirubin value can be biased by other disease conditions. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Extrahepatic Cholestasis
- What is being tested?
- External plastic endoprosthesis, Combined external internal plastic endoprosthesis and Primary metal stent
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2022to 15 Dec 2023
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with extrahepatic bile duct obstruction and failed or impossible ERCP
Who may be able to join
- technically successful PTBD
Who cannot join
- technically not successful PTBD
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Helios Kliniken Schwerin
Schwerin, 19055
Daniel Schmitz, MD, +491758674415, Daniel.Schmitz@helios-gesundheit.de
Martin Kliment, MD, +493855202601, Martin.Kliment@helios-gesundheit.de
About this study
Official title: Defining the Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures
The clinical success of percutaneous transhepatic biliary drainage procedures (PTBDs) is usually measured by the the decrease of the serum bilirubin value. However, the bilirubin value can be biased by other disease conditions. Furthermore, the time course of the decrease of the bilirubin value after technically successful PTBD is not well known. Serum gamma-glutamyl transferase (GGT), a liver enzyme which is typically elevated in cholestatic liver diseases, might be a good alternative to bilirubin as an indicator for the clinical success of PTBDs. The aim of this study is to analyse the bilirubin level and the GGT level in patients with technically successful PTBD.
Read the detailed description
The medical records of adult patients who have received a technically successful PTBD will be screened sytematically in terms of bilirubin and GGT values in the follow up of 4 weeks after the intervention. Bilirubin and GGT values have been routinely examinated every 1 to 3 days. PTBD comprises external plastic endoprosthesis, combined external and internal endoprosthesis and primary metal stent insertion. The respective three procedures are considered separately. As PTBD is a rare intervention which is used after failed or impossible endoscopic retrograde cholangiopancreaticography (ERCP) medical records will be screened from 2002 to 2022 (20 years). It is expected that for example a decrease of GGT after three days might indicate a successful procedure. This in turn might has an impact on the early demission of the patient. On the other side, the precise definition of successful PTBD by bilirubin or GGT value might help to make this procedure better comparable to other alternative biliary drainage procedures such as endoscopic ultrasound-guided biliary drainage.
- Conditions
- Extrahepatic Cholestasis
- Being tested
- External plastic endoprosthesis, Combined external internal plastic endoprosthesis, Primary metal stent
- Keywords
- Extrahepatic Cholestasis, Self Expandable Metallic Stents, Drainage
- Medical subject headings
- Cholestasis, Extrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External plastic endoprosthesisProcedure or surgery
Ultrasound- or fluoroscopy-guided bile duct puncture with insertion of an external plastic endoprosthesis if the duodenum or jejunum cannot be accessed by a guide wire
Combined external internal plastic endoprosthesisProcedure or surgery
Ultrasound- or fluoroscopy-guided bile duct puncture with insertion of an external/internal plastic endoprosthesis if the duodenum or jejunum can be accessed by a guide wire. No definitive drainage intended in initial procedure.
Primary metal stentProcedure or surgery
Ultrasound- or fluoroscopy-guided bile duct puncture with insertion of a self-expanding metal stent if the duodenum or jejunum can be accessed by a guide wire. A definitive drainage is intended in the initial procedure, for example in patients with malign bile duct obstruction
| Study group | Role | What they receive |
|---|---|---|
| Extrahepatic bile duct obstruction and failed ERCP | Patients with extrahepatic bile duct obstruction and obstructive jaundice have received a percutaneous transhepatic biliary drainage.
The choice between an insertion of an external or an external/internal drainage has been made during the procedure depending on whether the guide wire could be accessed to the jejunum/duodenum or not.
The choice between internal/external drainage or a primary metal stent has been made by the investigators preference or was made on the basis of an existing malign bile duct obstruction or not. Receives: Procedure: External plastic endoprosthesis; Procedure: Combined external internal plastic endoprosthesis; Procedure: Primary metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubin value
Change of serum bilirubin value
Measured: 4 weeks
GGT value
Change of serum bilirubin value
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 posted7 Mar 2022
- Study start15 Mar 2022
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extrahepatic CholestasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Helios Kliniken Schwerin
- Responsible party
- Sponsor
- Investigators
- Daniel Schmitz, MD, Principal investigator, Theresienkrankenhaus Mannheim, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268731
- Sponsor's protocol ID
- PTBD retro 003
- Acronym
- TransHepatic
- Status last verified
- Aug 2023
- First submitted
- 24 Feb 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data of the study will be available on request
Publications
Born P, Rosch T, Triptrap A, Frimberger E, Allescher HD, Ott R, Weigert N, Lorenz R, Classen M. Long-term results of percutaneous transhepatic biliary drainage for benign and malignant bile duct strictures. Scand J Gastroenterol. 1998 May;33(5):544-9. doi: 10.1080/00365529850172142.
PubMed 9648997Tsai CC, Mo LR, Lin RC, Kuo JY, Chang KK, Yeh YH, Yang SC, Yueh SK, Tsai HM, Yu CY. Self-expandable metallic stents in the management of malignant biliary obstruction. J Formos Med Assoc. 1996 Apr;95(4):298-302.
PubMed 8935298
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures
- ClinicalTrials.gov ID
- NCT05268731
- Acronym / sponsor ID
- TransHepatic / PTBD retro 003
- Conditions
- Extrahepatic Cholestasis
- Keywords
- Extrahepatic Cholestasis, Self Expandable Metallic Stents, Drainage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbHUniversity, hospital or other
- Collaborators
- Helios Kliniken Schwerin
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 7 Mar 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.
The clinical success of percutaneous transhepatic biliary drainage procedures (PTBDs) is usually measured by the the decrease of the serum bilirubin value. However, the bilirubin value can be biased by other disease conditions. Furthermore, the time course of the decrease of the bilirubin value after technically successful PTBD is not well known. Serum gamma-glutamyl transferase (GGT), a liver enzyme which is typically elevated in cholestatic liver diseases, might be a good alternative to bilirubin as an indicator for the clinical success of PTBDs. The aim of this study is to analyse the bilirubin level and the GGT level in patients with technically successful PTBD.
Detailed description
The medical records of adult patients who have received a technically successful PTBD will be screened sytematically in terms of bilirubin and GGT values in the follow up of 4 weeks after the intervention. Bilirubin and GGT values have been routinely examinated every 1 to 3 days. PTBD comprises external plastic endoprosthesis, combined external and internal endoprosthesis and primary metal stent insertion. The respective three procedures are considered separately. As PTBD is a rare intervention which is used after failed or impossible endoscopic retrograde cholangiopancreaticography (ERCP) medical records will be screened from 2002 to 2022 (20 years). It is expected that for example a decrease of GGT after three days might indicate a successful procedure. This in turn might has an impact on the early demission of the patient. On the other side, the precise definition of successful PTBD by bilirubin or GGT value might help to make this procedure better comparable to other alternative biliary drainage procedures such as endoscopic ultrasound-guided biliary drainage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extrahepatic bile duct obstruction and failed ERCP | – | Procedure: External plastic endoprosthesis, Procedure: Combined external internal plastic endoprosthesis, Procedure: Primary metal stentPatients with extrahepatic bile duct obstruction and obstructive jaundice have received a percutaneous transhepatic biliary drainage. The choice between an insertion of an external or an external/internal drainage has been made during the procedure depending on whether the guide wire could be accessed to the jejunum/duodenum or not. The choice between internal/external drainage or a primary metal stent has been made by the investigators preference or was made on the basis of an existing malign bile duct obstruction or not. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with extrahepatic bile duct obstruction and failed or impossible ERCP
Key inclusion criteria (1 listed)
- technically successful PTBD
Key exclusion criteria (1 listed)
- technically not successful PTBD
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 |
|---|---|---|
| External plastic endoprosthesisUltrasound- or fluoroscopy-guided bile duct puncture with insertion of an external plastic endoprosthesis if the duodenum or jejunum cannot be accessed by a guide wire | Procedure or surgery | Extrahepatic bile duct obstruction and failed ERCP |
| Combined external internal plastic endoprosthesisUltrasound- or fluoroscopy-guided bile duct puncture with insertion of an external/internal plastic endoprosthesis if the duodenum or jejunum can be accessed by a guide wire. No definitive drainage intended in initial procedure. | Procedure or surgery | Extrahepatic bile duct obstruction and failed ERCP |
| Primary metal stentUltrasound- or fluoroscopy-guided bile duct puncture with insertion of a self-expanding metal stent if the duodenum or jejunum can be accessed by a guide wire. A definitive drainage is intended in the initial procedure, for example in patients with malign bile duct obstruction | Procedure or surgery | Extrahepatic bile duct obstruction and failed ERCP |
Primary outcome
Bilirubin value
Time frame: 4 weeks
Change of serum bilirubin value
GGT value
Time frame: 4 weeks
Change of serum bilirubin value
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Results publication: PubMed 9648997Born P, Rosch T, Triptrap A, Frimberger E, Allescher HD, Ott R, Weigert N, Lorenz R, Classen M. Long-term results of percutaneous transhepatic biliary drainage for benign and malignant bile duct strictures. Scand J Gastroenterol. 1998 May;33(5):544-9. doi: 10.1080/00365529850172142.
- Results publication: PubMed 8935298Tsai CC, Mo LR, Lin RC, Kuo JY, Chang KK, Yeh YH, Yang SC, Yueh SK, Tsai HM, Yu CY. Self-expandable metallic stents in the management of malignant biliary obstruction. J Formos Med Assoc. 1996 Apr;95(4):298-302.
- Individual participant dataSharing planned: No. All data of the study will be available on request
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.
Daniel Schmitz, MD principal investigator
Theresienkrankenhaus Mannheim, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extrahepatic Cholestasis, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
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 1 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 29 Aug 2023. 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 Germany. 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 Dr.med. D Schmitz, MD (+49491758674415, s.daniel_427@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilirubin value (time frame: 4 weeks). 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 NCT05268731, which also lists 2 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 29 Aug 2023.