- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2022-08-01
2024-04-01
2024-07-01
61
NCT05519605
Radboud University Medical Center
Radboud University Medical Center
OBSERVATIONAL
Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-08-25 | N/A | 2024-04-10 |
2022-08-25 | N/A | 2024-04-11 |
2022-08-29 | N/A | 2023-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 180 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Technical success of the initial procedure | Defined as: the ability to access and drain the bile duct by placement of a stent/drain. | 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. | 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 | 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. | 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 | 180 days |
| Time to re-intervention and number of re-interventions | 180 days | |
| Successful training | Successful training defined as significant progress in learning curve calculated by a CUSUM-analysis | 180 days |
| Effect of EUS-BD and PTBD on the difficulty of surgery. | 180 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
