Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD

Pancreatic Cancer Clinical Trial

— BESTDRAIN  

Official title:

Bile Duct Drainage After ERCP Failure: EUS-guided Biliary Versus Percutaneous Transhepatic Drainage

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05519605
• Other study ID #: 113346
• Status: Active, not recruiting
• Start date: August 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Previous PTBD and/or EUS-BD

• Inability to provide informed consent

• Pregnancy

• American Society of Anesthesiology (ASA) Grade IV-V

Related Conditions & MeSH terms

• Biliary Obstruction
• Cholangiocarcinoma
• Pancreatic Cancer

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to re-intervention and number of re-interventions		180 days
Secondary	Successful training	Successful training defined as significant progress in learning curve calculated by a CUSUM-analysis	180 days
Secondary	Effect of EUS-BD and PTBD on the difficulty of surgery.		180 days