Biliary Disease Tract, Biliary Stenosis, Biliary Stents
Conditions
Keywords
ERCP, Malignant Biliary Stenosis, Supra-papillary, Trans-Papillary
Brief summary
This is a randomized controlled trial comparing patients with obstructive jaundice due to malignancies of the perihilar area of bile ducts and undergoing both preoperative and palliative biliary drainage. The comparison will focus on the technique:, on the one hand, an arm of patients undergoing standard-of-care ERCP with trans-papillary plastic protesis placement, and on the other hand, an experimental arm of patients undergoing suprapapillary plastic protesis placement with no sphincterotomy. The primary objective will be to compare the time-to-stent dysfunction in the two groups; secondary objectives will include a comparison of the safety, technical, and clinical success of the procedures.
Interventions
PROCEDUREERCP with suprapapillary stent placement
ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.
PROCEDUREERCP with transpapillary stent placement
Standard ERCP with or without sphincterotomy with trans papillary stent placement
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a single-blinded randomized controlled trial comparing two techniques used for the same procedure (ERCP and biliary stenting, suprapapillary vs transpapillary placement).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Radiological/ biochemical/pathological diagnosis of malignant OJ. 2. Stenosis maximum extent may be 2 cm after biliary confluence. 3. Documented obstructive jaundice (serum bilirubin \> 3 mg/dL). 4. Indication for biliary drainage (preoperative or palliative). 5. Age ≥ 18 years. 6. Signed informed consent.
Exclusion criteria
1. Contraindications to endoscopic approach (duodenal stenosis, surgically altered anatomy). 2. Previous sphincterotomy or drainage. 3. Involvement of the papilla of Vater by the tumour. 4. Uncontrolled coagulopathy (INR \> 1.5 uncorrectable or \<50.000 PLTs). 5. Ongoing uncontrolled cholangitis as defined according to the Tokyo 2018 Guidelines, or systemic sepsis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-Stent disfunction | From index procedure to a minimum of one year of follow up. | In days, calculated from the index procedure. Stent(s) dysfunction, which includes occlusion or migration of the stent(s) and tumour ingrowth/overgrowth, is defined as the presence of at least two of the following three criteria: 1. New dilation of the biliary tree on imaging: 2. Bilirubin level above 2 mg/dL (34.2 mmol/L) with a new increase ≥ 1 mg/dL compared with the value after initial clinical success, or elevation of alkaline phosphatase and/or g-glutamyl transferase greater than 2 times the upper normal limit with a new elevation of 30 U/L 3. Cholangitis, characterized by fever along with leucocytosis (\> 10,000/mL) or C-reactive protein levels above 20 mg/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the procedure | From the index procedure within 14 days. | The incidence of Adverse events and severe adverse events will be compared. Adverse events (AEs) (timepoint 14 days) are defined according to the ASGE lexicon and graded according to the Adverse Events in GI endoscopy (AGREE) classification that classifies AEs in 5 grades from Grade I, any deviation from standard postprocedural course without need for pharmacological or interventional treatment, to Grade V, death of the patient. Sub-group analysis will be performed for procedure-related AEs. Severe adverse events are defined as AGREE≥3. |
| Technical success | At the moment of index procedure. | Defined as the placement of the stent(s) in the desired position (timepoint 0) |
| Clinical Success | Between 14 and 30 days from the index procedure. | Defined as the reduction of bilirubin level ≥50% or at a level \<2 mg/dL (34.2 mmol/L). |
Contacts
Primary ContactAndrea Ruzzenente, Professor
Backup ContactEdoardo Poletto, PhD Candidate - Consultant
Outcome results
None listed