Pancreatic CancerBESTDRAINNCT05519605
Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD
An observational study of Pancreatic Cancer and Cholangiocarcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The vast majority of patients with distal biliary, pancreatic head or uncinate process cancer have jaundice caused by distal malignant obstruction (DMO) of the common bile duct. Biliary drainage by Endoscopic Retrograde Cholangiopancreatography (ERCP) with trans-papillary stent placement is the treatment of choice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Cholangiocarcinoma, Biliary Obstruction
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2022to 1 Jul 2024
- How long will I take part?
- 180 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older with a distal malignant obstruction of the common bile duct with failure of drainage by the initial ERCP will be included in this study. Failed biliary drainage is defined as failed common bile duct cannulation during ERCP by an experienced advanced endoscopist (>100 ERCP/year, case load > 500 ERCP).
Who may be able to join
- 18 years and older
- Distal malignant CBD obstruction (from ampulla to 1cm distal to the hilum)
- Indication for biliary drainage after failed ERCP-guided biliary drainage
Who cannot join
- Previous PTBD and/or EUS-BD
- Inability to provide informed consent
- Pregnancy
- American Society of Anesthesiology (ASA) Grade IV-V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bile Duct Drainage After ERCP Failure: EUS-guided Biliary Versus Percutaneous Transhepatic Drainage
The vast majority of patients with distal biliary, pancreatic head or uncinate process cancer have jaundice caused by distal malignant obstruction (DMO) of the common bile duct. Biliary drainage by Endoscopic Retrograde Cholangiopancreatography (ERCP) with trans-papillary stent placement is the treatment of choice.
ERCP has a failure rate ranging from 12 - 25 percent. Percutaneous transhepatic biliary drainage (PTBD) is the alternative conventional way to drain the biliary tree after ERCP failure, which is related with substantial morbidity (62%) and mortality (17%). Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is a novel promising drainage modality with reported excellent outcomes in terms of clinical success and complications.
The implementation of EUS-BD besides ERCP and PTBD into Dutch daily clinical practice raises many questions related to performance, costs, QoL, training, implementation and overall oncological treatment success. This structured learning/proctoring program with an additional national registry provides insights into EUS-BD and how to implement EUS-BD in the Dutch standard of care.
Read the detailed description
The study is designed as a prospective multicenter registry. The data obtained in this study will enable the EUS-BD procedure to progress to larger multicenter and preferably randomized control trials.
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Biliary Obstruction
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PTBD after failed ERCP | Patients with a distal malignant obstruction undergoing placement of a percutaneous transhepatic biliary drain after failed ERCP. | |
| EUS-BD after failed ERCP | Patients with a distal malignant obstruction undergoing EUS-guided biliary drainage after failed ERCP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of PTBD vs EUS-BD
The primary outcome measure is a composite of severe complications occurring within 180 days following inclusion, analyzed by intention to treat. Complications we score are: bleeding, perforation, biliary leak, biliary peritonitis, abscess, haemobilia, stent occlusion, cholangitis, pancreatitis, anesthesia related complications, severe post-procedural pain, drain/stent dysfunction, cutaneous fistula, stent migration and drain leakage or dislocation.
Measured: 180 days
Secondary outcomes (8)
Technical success of the initial procedure
Defined as: the ability to access and drain the bile duct by placement of a stent/drain.
Measured: 180 days
Clinical success
A post-intervention reduction of bilirubin below 35 umol/L or a significant decline, so that chemotherapy could be administered at the discretion of the oncologist. Serum bilirubin is routinely measured as part of clinical practice after biliary drainage.
Measured: 180 days
Length of hospital stay
Split into total admission days, length of initial admission and total duration of subsequent admissions; an out-patient procedure performed at the hospital is counted as one admission day
Measured: 180 days
Stent/drain patency
Stent/drain patency is measured by the interval (days) between the time of stent placement and stent/drain malfunction or patient death.
Measured: 180 days
Treatment delay
For each severe complication, the treatment team will be asked whether the complication would alter (delay or modify) the pre-existing treatment plan
Measured: 180 days
Time to re-intervention and number of re-interventions
Measured: 180 days
Successful training
Successful training defined as significant progress in learning curve calculated by a CUSUM-analysis
Measured: 180 days
Effect of EUS-BD and PTBD on the difficulty of surgery.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Apr 2024
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Prospective
- Enrolment
- 61 participants (actual)
- Target duration
- 180 Days
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519605
- Sponsor's protocol ID
- 113346
- Acronym
- BESTDRAIN
- Status last verified
- Dec 2023
- First submitted
- 25 Aug 2022
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The dataset used during this study is available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bile Duct Drainage After ERCP Failure: EUS-guided Biliary Versus Percutaneous Transhepatic Drainage
- ClinicalTrials.gov ID
- NCT05519605
- Acronym / sponsor ID
- BESTDRAIN / 113346
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Biliary Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 29 Aug 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 vast majority of patients with distal biliary, pancreatic head or uncinate process cancer have jaundice caused by distal malignant obstruction (DMO) of the common bile duct. Biliary drainage by Endoscopic Retrograde Cholangiopancreatography (ERCP) with trans-papillary stent placement is the treatment of choice.
ERCP has a failure rate ranging from 12 - 25 percent. Percutaneous transhepatic biliary drainage (PTBD) is the alternative conventional way to drain the biliary tree after ERCP failure, which is related with substantial morbidity (62%) and mortality (17%). Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is a novel promising drainage modality with reported excellent outcomes in terms of clinical success and complications.
The implementation of EUS-BD besides ERCP and PTBD into Dutch daily clinical practice raises many questions related to performance, costs, QoL, training, implementation and overall oncological treatment success. This structured learning/proctoring program with an additional national registry provides insights into EUS-BD and how to implement EUS-BD in the Dutch standard of care.
Detailed description
The study is designed as a prospective multicenter registry. The data obtained in this study will enable the EUS-BD procedure to progress to larger multicenter and preferably randomized control trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 180 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTBD after failed ERCP | – | –Patients with a distal malignant obstruction undergoing placement of a percutaneous transhepatic biliary drain after failed ERCP. |
| EUS-BD after failed ERCP | – | –Patients with a distal malignant obstruction undergoing EUS-guided biliary drainage after failed ERCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older with a distal malignant obstruction of the common bile duct with failure of drainage by the initial ERCP will be included in this study. Failed biliary drainage is defined as failed common bile duct cannulation during ERCP by an experienced advanced endoscopist (>100 ERCP/year, case load > 500 ERCP).
Key inclusion criteria (3 listed)
- 18 years and older
- Distal malignant CBD obstruction (from ampulla to 1cm distal to the hilum)
- Indication for biliary drainage after failed ERCP-guided biliary drainage
Key exclusion criteria (4 listed)
- Previous PTBD and/or EUS-BD
- Inability to provide informed consent
- Pregnancy
- American Society of Anesthesiology (ASA) Grade IV-V
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications of PTBD vs EUS-BD
Time frame: 180 days
The primary outcome measure is a composite of severe complications occurring within 180 days following inclusion, analyzed by intention to treat. Complications we score are: bleeding, perforation, biliary leak, biliary peritonitis, abscess, haemobilia, stent occlusion, cholangitis, pancreatitis, anesthesia related complications, severe post-procedural pain, drain/stent dysfunction, cutaneous fistula, stent migration and drain leakage or dislocation.
8 secondary outcomes
Technical success of the initial procedure
Time frame: 180 days
Clinical success
Time frame: 180 days
Length of hospital stay
Time frame: 180 days
Stent/drain patency
Time frame: 180 days
Treatment delay
Time frame: 180 days
Time to re-intervention and number of re-interventions
Time frame: 180 days
Successful training
Time frame: 180 days
Effect of EUS-BD and PTBD on the difficulty of surgery.
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided. The dataset used during this study is available from the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic Cancer and Cholangiocarcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 4 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 11 Apr 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 Netherlands. 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?
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?
Complications of PTBD vs EUS-BD (time frame: 180 days). 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 11 Apr 2024.