Biliary DrainagePROBILEUSNCT07817602
Real-world Evaluation of Different Endoscopic Biliary Drainage Techniques in Patients With Jaundice of Biliopancreatic Malignant Origin
An observational study of Biliary Drainage and Endoscopic Ultrasound-Guided Drainage, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
Trial summary
The incidence of pancreatic cancer is rising. Tumor-induced obstruction of the distal bile duct is a common complication, occurring during the course of nearly 80% of pancreatic tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Drainage, Endoscopic Ultrasound-Guided Drainage, Pancreatic Cancer
- What is being tested?
- Endoscopic drainage
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 6 sitesFrance
- Study dates
- Sep 2026to Sep 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with distal biliary obstruction of malignant etiology (pancreas, ampulloma, compressive metastatic lymphadenopathy, other distal tumors, with planned biliary drainage.
Who may be able to join
- Distal biliary obstruction of malignant etiology (pancreas, ampulloma, compressive metastatic lymphadenopathy, other distal tumors).
- Decision made to proceed with biliary drainage.
- Patient informed and no objection raised, in accordance with the MR-004 framework and COPPINE procedure
Who cannot join
- The subject is participating in another study
- The subject unable to expression on-objection
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Proximal/hilar or benign obstruction (non-tumoral lesions).
- Contraindication to endoscopy/anesthesia (uncorrectable hemodynamic instability, uncontrolled coagulation disorders, etc.).
- History of prior biliary drainage.
- Pregnant or breastfeeding patient.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
CHU Dupuytren
Limoges
Jérémie ALBOUYS, 07.60.04.98.98, jeremie.albouys@gmail.com
Hôpital Edouard Herriot
Lyon
Mathieu PIOCHE, 04.72.11.73.11, mathieu.pioche@chu-lyon.fr
Hôpital Saint-Eloi
Montpellier
Antoine DEBOURDEAU, 06.68.31.94.89, a-debourdeau@chu-debourdeau.fr
Chu Nimes
Nîmes, 30900
Ludovic CAILLO, Dr, 0466683794, ludovic.caillo@chu-nimes.fr
Hôpital Saint-Antoine
Paris
Diane LORENZO, 06.27.91.93.39, diane.lorenzo@gmail.com
CHRU Nancy
Vandœuvre-lès-Nancy
Marion SCHAEFER, 06.42.74.33.30, m.schaefer@chru-nancy.fr
About this study
The incidence of pancreatic cancer is rising. Tumor-induced obstruction of the distal bile duct is a common complication, occurring during the course of nearly 80% of pancreatic tumors. Approximately 10% of these obstructions are complicated by cholangitis, and jaundice is associated with tumor progression due to the resulting impairment of cellular immunity. The standard treatment for distal bile duct obstruction is transpapillary drainage via endoscopic retrograde cholangiopancreatography (ERCP). This procedure is performed under general anesthesia and carries a failure rate of 15% and a complication rate of up to 9%. In recent years, alternative techniques for endoscopic ultrasound (EUS)-guided biliary drainage have been developed, such as hepaticogastrostomy, choledochoduodenostomy, and cholecystogastrostomy. These EUS-guided biliary drainage techniques overcome failures caused by malignant duodenal stenosis (present in up to 25% of such cases), with lower morbidity and greater clinical efficacy compared to percutaneous radiological drainage. EUS-guided biliary drainage techniques have been simplified by the advent of lumen-apposing metal stents (LAMS), which have enabled technical success rates of nearly 90%. The two techniques most frequently described in the literature are choledochoduodenostomy (CDS)-connecting the common bile duct to the duodenal bulb-and hepaticogastrostomy (HGS)-connecting the left intrahepatic bile ducts to the stomach. CDS is less morbid and technically easier to perform but has limitations in cases of duodenal stenosis, an insufficiently dilated common bile duct, or an unfavorable puncture window. For a long time, endoscopic gallbladder drainage via cholecystogastrostomy (CGS) was restricted to treating acute cholecystitis in patients ineligible for surgery; its use for biliary drainage in cases of malignant jaundice remained anecdotal, for reasons that were not clearly identified. The investigators were the first to publish a multicenter comparative study contrasting CGS with CDS following failed ERCP for distal malignant biliary obstruction. This study demonstrated comparable technical and clinical success rates for both techniques, with a better long-term morbidity profile favoring CGS. More recently, a large-scale international multicenter study validated the efficacy of gallbladder drainage compared to common bile duct drainage as a first-line approach. The study team previously launched the COPPINE cohort (Prospective Cohort of Innovative Endoscopic Procedures) in 2024, aiming to continuously enroll all patients undergoing innovative endoscopic procedures, including endoscopic ultrasound-guided biliary drainage. This study aims to prospectively compare the clinical outcomes of patients with malignant distal biliary obstruction based on the biliary drainage technique they received.
- Being tested
- Endoscopic drainage
- Keywords
- Gallbladder drainage, Choledochoduodenostomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic drainageProcedure or surgery
Choice of modalities: ERCP, EUS-guided gallbladder drainage (EUS-GBD), EUS-guided choledochoduodenostomy (EUS-CDS), and EUS-guided hepaticogastrostomy (EUS-HGS)
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing endoscopic drainage | Not described Receives: Procedure: Endoscopic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biliary stent dysfunction between different endoscopic drainage modalities
Yes/no, according to Guidelines on Reporting Outcomes in Biliary Drainage Trials
Measured: Month 12
Secondary outcomes (46)
Technical success rate of biliary stent placement with immediate visualization of biliary flow during the procedure between different endoscopic drainage modalities
Yes/no, where stent malposition or incomplete deployment requiring conversion or rescue maneuvers will not be considered technical successes.
Measured: Month 12
Clinical success
Yes/no, measured as reduction of ≥50% in total bilirubin level compared to the pre-procedural value within 2 weeks of the index procedure, or achieving a total bilirubin level of less than 25% of the pre-procedural value within 6 weeks
Measured: Month 12
Use of advanced cannulation techniques versus endoscopic ultrasound (EUS)-guided techniques in cases of difficult ERCP
Yes/no for use of: double-guidewire technique, precut, infundibulotomy, other
Measured: Month 12
Segment showing highest drainage efficacy
Segment (II or III) with best bilirubin levels (µmol/L)
Measured: Month 12
Tumor stage
TNM staging
Measured: Month 12
Tumor size
cm
Measured: Month 12
Tumor invasion of the cystic-common bile duct junction
Yes/no
Measured: Month 12
Distance between the tumor and the cystic-common bile duct junction
mm
Measured: Month 12
Physician experience
Classed as: resident, senior registrar/assistant, junior attending (<500 procedures), or experienced attending (>500 procedures)
Measured: Month 12
Location of stenosis
Classed as: pylorus, D1, D2, D3, D4, jejunum, or multiple segments
Measured: Month 12
length of stenosis
cm
Measured: Month 12
tumor invasion of the papilla
yes/no
Measured: Month 12
Clinical success rate
Yes/no, where success is classed as ≥50% reduction in total bilirubin levels compared to the pre-procedural value within 2 weeks of the index procedure, or achieving a total bilirubin level below 25% of the pre-procedural value within 6 weeks.
Measured: Month 12
Bilirubin levels
µmol/l
Measured: Day 0, Day 14, Day 45, Month 6, and Month 12.
New biliary drainage procedure
Yes/no
Measured: Month 12
Interval between the 1st and 2nd procedure if necessary
Days
Measured: Month 12
Re-intervention strategy/types of re-intervention
Classed as: ERCP, HGS, CGS, CDS, radiological drainage
Measured: Month 12
Time to initiation of chemotherapy
Measured from day of the endoscopic procedure and Day 1 of chemotherapy
Measured: Month 12
Proportion of patients with a surgical plan
Yes/no
Measured: Month 12
Proportion of patients with a chemotherapy plan
Yes/no
Measured: Month 12
Proportion of patients with a palliative care plan
Yes/no
Measured: Month 12
Proportion of patients for whom surgery performed
Yes/no
Measured: Month 12
Proportion of patients for whom chemotherapy performed
Yes/no
Measured: Month 12
surgical complication related to the prior endoscopic procedure
Yes/no
Measured: Month 12
Technique used in cases of duodenal stenosis
Classed as: ERCP, HGS, CDS, CGS, radiological drainage
Measured: Month 12
CGS drainage technique
Classed as cholecystogastric or cholecystoduodenal
Measured: Month 12
Cumulative incidence of adverse events
Number
Measured: Month 12
Timing of adverse events
Classed as: early: <30 days; late: ≥30 days
Measured: Month 12
Causality of adverse events
Classed as: procedure-related, disease-related, or unrelated
Measured: Month 12
Severity of adverse events
According to the AGREE classification (grades I to V) and the ASGE lexicon (Nass et al. 2022); - Specifically reported adverse events will include: cholangitis, bile leak, hemorrhage, pneumoperitoneum, perforation, stent migration, stent occlusion, cholecystitis (EUS-GBD arm), and buried stent syndrome. Chemotherapy interruption directly attributable to a drainage-related event will be documented as an indirect adverse event.
Measured: Month 12
Overall survival between different endoscopic drainage modalities
Measured: Month 12
Survival free from biliary re-intervention between different endoscopic drainage modalities
Measured: Month 12
Mean total cost per patient
Including the initial procedure, expressed in euros; calculated from the perspective of the healthcare system (hospitals + health insurance) and including the costs of hospitalizations, transport, and endoscopic procedures (initial procedure and any re-interventions).
Measured: Month 12
Proportion of operable or borderline patients who were surgically explored
Defined as the actual performance of a laparotomy or laparoscopy with the aim of pancreatic resection
Measured: Month 12
Proportion of operable or borderline patients who were resected
Defined as the performance of a pancreatic resection procedure
Measured: Month 12
Need for an associated vascular procedure
yes/no (including venous or arterial resection and/or reconstruction)
Measured: Month 12
Conversion to laparotomy in patients initially operated on via a minimally invasive approach
Yes/no
Measured: Month 12
Margin status
Resection margin status: R0 / R1
Measured: Month 12
Lymph node dissection
Number of lymph nodes analyzed: continuous quantitative variable (absolute number)
Measured: Month 12
Postoperative pathological stage (ypTNM)
measured according to the classification in effect at the time of surgery
Measured: Month 12
Presence of severe morbidity
Occurrence of at least one severe postoperative complication, defined as: Clavien-Dindo ≥ III
Measured: Month 12
30-day mortality
Yes/no
Measured: Day 30
90-day mortality
Yes/no
Measured: Day 90
Feasibility rate
Percentage of centers that enrolled at least 5 patients within the scheduled timeframe
Measured: Month 24
Enrollment rate for eligible patients
Calculated as: number of patients enrolled / number of eligible patients identified
Measured: Month 12
Data completeness rate for the minimum variables required for the future registry
Percentage
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary DrainageStudies 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
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludovic Caillo, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817602
- Sponsor's protocol ID
- NIMAO/2025-2/LC01
- Acronym
- PROBILEUS
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of Different Endoscopic Biliary Drainage Techniques in Patients With Jaundice of Biliopancreatic Malignant Origin
- ClinicalTrials.gov ID
- NCT07817602
- Acronym / sponsor ID
- PROBILEUS / NIMAO/2025-2/LC01
- Keywords
- Gallbladder drainage, Choledochoduodenostomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Sep 2026 (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 incidence of pancreatic cancer is rising. Tumor-induced obstruction of the distal bile duct is a common complication, occurring during the course of nearly 80% of pancreatic tumors. Approximately 10% of these obstructions are complicated by cholangitis, and jaundice is associated with tumor progression due to the resulting impairment of cellular immunity. The standard treatment for distal bile duct obstruction is transpapillary drainage via endoscopic retrograde cholangiopancreatography (ERCP). This procedure is performed under general anesthesia and carries a failure rate of 15% and a complication rate of up to 9%. In recent years, alternative techniques for endoscopic ultrasound (EUS)-guided biliary drainage have been developed, such as hepaticogastrostomy, choledochoduodenostomy, and cholecystogastrostomy. These EUS-guided biliary drainage techniques overcome failures caused by malignant duodenal stenosis (present in up to 25% of such cases), with lower morbidity and greater clinical efficacy compared to percutaneous radiological drainage. EUS-guided biliary drainage techniques have been simplified by the advent of lumen-apposing metal stents (LAMS), which have enabled technical success rates of nearly 90%. The two techniques most frequently described in the literature are choledochoduodenostomy (CDS)-connecting the common bile duct to the duodenal bulb-and hepaticogastrostomy (HGS)-connecting the left intrahepatic bile ducts to the stomach. CDS is less morbid and technically easier to perform but has limitations in cases of duodenal stenosis, an insufficiently dilated common bile duct, or an unfavorable puncture window. For a long time, endoscopic gallbladder drainage via cholecystogastrostomy (CGS) was restricted to treating acute cholecystitis in patients ineligible for surgery; its use for biliary drainage in cases of malignant jaundice remained anecdotal, for reasons that were not clearly identified. The investigators were the first to publish a multicenter comparative study contrasting CGS with CDS following failed ERCP for distal malignant biliary obstruction. This study demonstrated comparable technical and clinical success rates for both techniques, with a better long-term morbidity profile favoring CGS. More recently, a large-scale international multicenter study validated the efficacy of gallbladder drainage compared to common bile duct drainage as a first-line approach. The study team previously launched the COPPINE cohort (Prospective Cohort of Innovative Endoscopic Procedures) in 2024, aiming to continuously enroll all patients undergoing innovative endoscopic procedures, including endoscopic ultrasound-guided biliary drainage. This study aims to prospectively compare the clinical outcomes of patients with malignant distal biliary obstruction based on the biliary drainage technique they received.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing endoscopic drainage | – | Procedure: Endoscopic drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with distal biliary obstruction of malignant etiology (pancreas, ampulloma, compressive metastatic lymphadenopathy, other distal tumors, with planned biliary drainage.
Key inclusion criteria (3 listed)
- Distal biliary obstruction of malignant etiology (pancreas, ampulloma, compressive metastatic lymphadenopathy, other distal tumors).
- Decision made to proceed with biliary drainage.
- Patient informed and no objection raised, in accordance with the MR-004 framework and COPPINE procedure
Key exclusion criteria (8 listed)
- The subject is participating in another study
- The subject unable to expression on-objection
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Proximal/hilar or benign obstruction (non-tumoral lesions).
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 |
|---|---|---|
| Endoscopic drainageChoice of modalities: ERCP, EUS-guided gallbladder drainage (EUS-GBD), EUS-guided choledochoduodenostomy (EUS-CDS), and EUS-guided hepaticogastrostomy (EUS-HGS) | Procedure or surgery | Patients undergoing endoscopic drainage |
Primary outcome
Biliary stent dysfunction between different endoscopic drainage modalities
Time frame: Month 12
Yes/no, according to Guidelines on Reporting Outcomes in Biliary Drainage Trials
46 secondary outcomes
Technical success rate of biliary stent placement with immediate visualization of biliary flow during the procedure between different endoscopic drainage modalities
Time frame: Month 12
Clinical success
Time frame: Month 12
Use of advanced cannulation techniques versus endoscopic ultrasound (EUS)-guided techniques in cases of difficult ERCP
Time frame: Month 12
Segment showing highest drainage efficacy
Time frame: Month 12
Tumor stage
Time frame: Month 12
Tumor size
Time frame: Month 12
Tumor invasion of the cystic-common bile duct junction
Time frame: Month 12
Distance between the tumor and the cystic-common bile duct junction
Time frame: Month 12
Physician experience
Time frame: Month 12
Location of stenosis
Time frame: Month 12
length of stenosis
Time frame: Month 12
tumor invasion of the papilla
Time frame: Month 12
Clinical success rate
Time frame: Month 12
Bilirubin levels
Time frame: Day 0, Day 14, Day 45, Month 6, and Month 12.
New biliary drainage procedure
Time frame: Month 12
Interval between the 1st and 2nd procedure if necessary
Time frame: Month 12
Re-intervention strategy/types of re-intervention
Time frame: Month 12
Time to initiation of chemotherapy
Time frame: Month 12
Proportion of patients with a surgical plan
Time frame: Month 12
Proportion of patients with a chemotherapy plan
Time frame: Month 12
Proportion of patients with a palliative care plan
Time frame: Month 12
Proportion of patients for whom surgery performed
Time frame: Month 12
Proportion of patients for whom chemotherapy performed
Time frame: Month 12
surgical complication related to the prior endoscopic procedure
Time frame: Month 12
Technique used in cases of duodenal stenosis
Time frame: Month 12
CGS drainage technique
Time frame: Month 12
Cumulative incidence of adverse events
Time frame: Month 12
Timing of adverse events
Time frame: Month 12
Causality of adverse events
Time frame: Month 12
Severity of adverse events
Time frame: Month 12
Overall survival between different endoscopic drainage modalities
Time frame: Month 12
Survival free from biliary re-intervention between different endoscopic drainage modalities
Time frame: Month 12
Mean total cost per patient
Time frame: Month 12
Proportion of operable or borderline patients who were surgically explored
Time frame: Month 12
Proportion of operable or borderline patients who were resected
Time frame: Month 12
Need for an associated vascular procedure
Time frame: Month 12
Conversion to laparotomy in patients initially operated on via a minimally invasive approach
Time frame: Month 12
Margin status
Time frame: Month 12
Lymph node dissection
Time frame: Month 12
Postoperative pathological stage (ypTNM)
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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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.
Ludovic Caillo principal investigator
Centre Hospitalier Universitaire de Nīmes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Drainage and Endoscopic Ultrasound-Guided Drainage, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
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 8 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludovic Caillo (06.70.88.85.07, ludovic.caillo@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biliary stent dysfunction between different endoscopic drainage modalities (time frame: Month 12). 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 14 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.