Biliary Disease TractSupraBilSNCT07325877
Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis
A study testing ERCP with suprapapillary stent placement and ERCP with transpapillary stent placement in people with Biliary Disease Tract and Biliary Stenosis, run by Azienda Ospedaliera Universitaria Integrata Verona.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Disease Tract, Biliary Stenosis, Biliary Stents
- What is being tested?
- ERCP with suprapapillary stent placement and ERCP with transpapillary stent placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2029
- Phase
- Interventional
- 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
Who may be able to join
- Radiological/ biochemical/pathological diagnosis of malignant OJ.
- Stenosis maximum extent may be 2 cm after biliary confluence.
- Documented obstructive jaundice (serum bilirubin > 3 mg/dL).
- Indication for biliary drainage (preoperative or palliative).
- Age ≥ 18 years.
- Signed informed consent.
Who cannot join
- Contraindications to endoscopic approach (duodenal stenosis, surgically altered anatomy).
- Previous sphincterotomy or drainage.
- Involvement of the papilla of Vater by the tumour.
- Uncontrolled coagulopathy (INR > 1.5 uncorrectable or <50.000 PLTs).
- Ongoing uncontrolled cholangitis as defined according to the Tokyo 2018 Guidelines, or systemic sepsis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis (SupraBilS): a Randomized Controlled Trial
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.
- Conditions
- Biliary Disease Tract, Biliary Stenosis, Biliary Stents
- Being tested
- ERCP with suprapapillary stent placement, ERCP with transpapillary stent placement
- Keywords
- ERCP, Malignant Biliary Stenosis, Supra-papillary, Trans-Papillary
- Medical subject headings
- Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with suprapapillary stent placementProcedure or surgery
ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.
ERCP with transpapillary stent placementProcedure or surgery
Standard ERCP with or without sphincterotomy with trans papillary stent placement
| Study group | Role | What they receive |
|---|---|---|
| Suprapapillary | Experimental | ERCP for malignant stenosis of bile duct with suprapapillary stents positioning (experimental) Receives: Procedure: ERCP with suprapapillary stent placement |
| Trans Papillary | Active comparator | ERCP for malignant stenosis of bile duct with transpapillary stents positioning (Standard of care). Receives: Procedure: ERCP with transpapillary stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Stent disfunction
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:
- New dilation of the biliary tree on imaging:
- 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
- Cholangitis, characterized by fever along with leucocytosis (> 10,000/mL) or C-reactive protein levels above 20 mg/dL.
Measured: From index procedure to a minimum of one year of follow up.
Secondary outcomes (3)
Safety of the procedure
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.
Measured: From the index procedure within 14 days.
Technical success
Defined as the placement of the stent(s) in the desired position (timepoint 0)
Measured: At the moment of index procedure.
Clinical Success
Defined as the reduction of bilirubin level ≥50% or at a level <2 mg/dL (34.2 mmol/L).
Measured: Between 14 and 30 days from the index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Biliary Disease TractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Ruzzenente, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Andrea Ruzzenente, Professor, Principal investigator, Integrated University Hospital VeronaStefano Francesco Crinò, Consultant, Study director, Integrated University Hospital VeronaEdoardo Poletto, PhD Candidate, Consultant, Study chair, Integrated university Hospital VeronaMaria Cristina Conti Bellocchi, Consultant, Study chair, Integrated University Hospital Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325877
- Sponsor's protocol ID
- ID0001
- Other IDs
- ID0001
- Acronym
- SupraBilS
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Question asked to the ethics committee, decision is still pending.
Publications
Naitoh I, Inoue T. Optimal endoscopic drainage strategy for unresectable malignant hilar biliary obstruction. Clin Endosc. 2023 Mar;56(2):135-142. doi: 10.5946/ce.2022.150. Epub 2023 Jan 5.
PubMed 36600654Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
PubMed 31078660Kiriyama S, Kozaka K, Takada T, Strasberg SM, Pitt HA, Gabata T, Hata J, Liau KH, Miura F, Horiguchi A, Liu KH, Su CH, Wada K, Jagannath P, Itoi T, Gouma DJ, Mori Y, Mukai S, Gimenez ME, Huang WS, Kim MH, Okamoto K, Belli G, Dervenis C, Chan ACW, Lau WY, Endo I, Gomi H, Yoshida M, Mayumi T, Baron TH, de Santibanes E, Teoh AYB, Hwang TL, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Higuchi R, Kitano S, Inomata M, Deziel DJ, Jonas E, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):17-30. doi: 10.1002/jhbp.512. Epub 2018 Jan 5.
PubMed 29032610Nass KJ, Zwager LW, van der Vlugt M, Dekker E, Bossuyt PMM, Ravindran S, Thomas-Gibson S, Fockens P. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc. 2022 Jun;95(6):1078-1085.e8. doi: 10.1016/j.gie.2021.11.038. Epub 2021 Dec 8.
PubMed 34890695Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503Kovacs N, Pecsi D, Sipos Z, Farkas N, Foldi M, Hegyi P, Bajor J, Eross B, Marta K, Miko A, Rakonczay Z Jr, Sarlos P, Abraham S, Vincze A. Suprapapillary Biliary Stents Have Longer Patency Times than Transpapillary Stents-A Systematic Review and Meta-Analysis. J Clin Med. 2023 Jan 23;12(3):898. doi: 10.3390/jcm12030898.
PubMed 36769545Okamoto T, Fujioka S, Yanagisawa S, Yanaga K, Kakutani H, Tajiri H, Urashima M. Placement of a metallic stent across the main duodenal papilla may predispose to cholangitis. Gastrointest Endosc. 2006 May;63(6):792-6. doi: 10.1016/j.gie.2005.05.015.
PubMed 16650540Keulen AV, Gaspersz MP, van Vugt JLA, Roos E, Olthof PB, Coelen RJS, Bruno MJ, van Driel LMJW, Voermans RP, van Eijck CHJ, van Hooft JE, van Lienden KP, de Jonge J, Polak WG, Poley JW, Pek CJ, Moelker A, Willemssen FEJA, van Gulik TM, Erdmann JI, Hol L, IJzermans JNM, Buttner S, Koerkamp BG. Success, complication, and mortality rates of initial biliary drainage in patients with unresectable perihilar cholangiocarcinoma. Surgery. 2022 Dec;172(6):1606-1613. doi: 10.1016/j.surg.2022.06.028. Epub 2022 Aug 18.
PubMed 35989132Ipek S, Alper E, Cekic C, Cerrah S, Arabul M, Aslan F, Unsal B. Evaluation of the effectiveness of endoscopic retrograde cholangiopancreatography in patients with perihilar cholangiocarcinoma and its effect on development of cholangitis. Gastroenterol Res Pract. 2014;2014:508286. doi: 10.1155/2014/508286. Epub 2014 May 27.
PubMed 24982670Vogel A, Bridgewater J, Edeline J, Kelley RK, Klumpen HJ, Malka D, Primrose JN, Rimassa L, Stenzinger A, Valle JW, Ducreux M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127-140. doi: 10.1016/j.annonc.2022.10.506. Epub 2022 Nov 10. No abstract available.
PubMed 36372281Qumseya BJ, Jamil LH, Elmunzer BJ, Riaz A, Ceppa EP, Thosani NC, Buxbaum JL, Storm AC, Sawhney MS, Pawa S, Naveed M, Lee JK, Law JK, Kwon RS, Jue TL, Fujii-Lau LL, Fishman DS, Calderwood AH, Amateau SK, Al-Haddad M, Wani S. ASGE guideline on the role of endoscopy in the management of malignant hilar obstruction. Gastrointest Endosc. 2021 Aug;94(2):222-234.e22. doi: 10.1016/j.gie.2020.12.035. Epub 2021 May 20.
PubMed 34023067Boulay BR, Birg A. Malignant biliary obstruction: From palliation to treatment. World J Gastrointest Oncol. 2016 Jun 15;8(6):498-508. doi: 10.4251/wjgo.v8.i6.498.
PubMed 27326319Hameed A, Pang T, Chiou J, Pleass H, Lam V, Hollands M, Johnston E, Richardson A, Yuen L. Percutaneous vs. endoscopic pre-operative biliary drainage in hilar cholangiocarcinoma - a systematic review and meta-analysis. HPB (Oxford). 2016 May;18(5):400-10. doi: 10.1016/j.hpb.2016.03.002. Epub 2016 Apr 4.
PubMed 27154803Pavlidis ET, Pavlidis TE. Pathophysiological consequences of obstructive jaundice and perioperative management. Hepatobiliary Pancreat Dis Int. 2018 Feb;17(1):17-21. doi: 10.1016/j.hbpd.2018.01.008. Epub 2018 Jan 31.
PubMed 29428098Ruzzenente A, Alaimo L, Caputo M, Conci S, Campagnaro T, De Bellis M, Bagante F, Pedrazzani C, Guglielmi A. Infectious complications after surgery for perihilar cholangiocarcinoma: A single Western center experience. Surgery. 2022 Sep;172(3):813-820. doi: 10.1016/j.surg.2022.04.028. Epub 2022 May 24.
PubMed 35618490
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis (SupraBilS): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07325877
- Acronym / sponsor ID
- SupraBilS / ID0001
- Conditions
- Biliary Disease Tract, Biliary Stenosis, Biliary Stents
- Keywords
- ERCP, Malignant Biliary Stenosis, Supra-papillary, Trans-Papillary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 8 Jan 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Suprapapillary | Experimental | Procedure: ERCP with suprapapillary stent placementERCP for malignant stenosis of bile duct with suprapapillary stents positioning (experimental) |
| Trans Papillary | Active comparator | Procedure: ERCP with transpapillary stent placementERCP for malignant stenosis of bile duct with transpapillary stents positioning (Standard of care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Radiological/ biochemical/pathological diagnosis of malignant OJ.
- Stenosis maximum extent may be 2 cm after biliary confluence.
- Documented obstructive jaundice (serum bilirubin > 3 mg/dL).
- Indication for biliary drainage (preoperative or palliative).
- Age ≥ 18 years.
Key exclusion criteria (5 listed)
- Contraindications to endoscopic approach (duodenal stenosis, surgically altered anatomy).
- Previous sphincterotomy or drainage.
- Involvement of the papilla of Vater by the tumour.
- Uncontrolled coagulopathy (INR > 1.5 uncorrectable or <50.000 PLTs).
- Ongoing uncontrolled cholangitis as defined according to the Tokyo 2018 Guidelines, or systemic sepsis.
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 |
|---|---|---|
| ERCP with suprapapillary stent placementERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater. | Procedure or surgery | Suprapapillary |
| ERCP with transpapillary stent placementStandard ERCP with or without sphincterotomy with trans papillary stent placement | Procedure or surgery | Trans Papillary |
Primary outcome
Time-to-Stent disfunction
Time frame: 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.
3 secondary outcomes
Safety of the procedure
Time frame: From the index procedure within 14 days.
Technical success
Time frame: At the moment of index procedure.
Clinical Success
Time frame: Between 14 and 30 days from the index procedure.
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 8 Jan 2026.
- Background: PubMed 36600654Naitoh I, Inoue T. Optimal endoscopic drainage strategy for unresectable malignant hilar biliary obstruction. Clin Endosc. 2023 Mar;56(2):135-142. doi: 10.5946/ce.2022.150. Epub 2023 Jan 5.
- Background: PubMed 31078660Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
- Background: PubMed 29032610Kiriyama S, Kozaka K, Takada T, Strasberg SM, Pitt HA, Gabata T, Hata J, Liau KH, Miura F, Horiguchi A, Liu KH, Su CH, Wada K, Jagannath P, Itoi T, Gouma DJ, Mori Y, Mukai S, Gimenez ME, Huang WS, Kim MH, Okamoto K, Belli G, Dervenis C, Chan ACW, Lau WY, Endo I, Gomi H, Yoshida M, Mayumi T, Baron TH, de Santibanes E, Teoh AYB, Hwang TL, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Higuchi R, Kitano S, Inomata M, Deziel DJ, Jonas E, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):17-30. doi: 10.1002/jhbp.512. Epub 2018 Jan 5.
- Background: PubMed 34890695Nass KJ, Zwager LW, van der Vlugt M, Dekker E, Bossuyt PMM, Ravindran S, Thomas-Gibson S, Fockens P. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc. 2022 Jun;95(6):1078-1085.e8. doi: 10.1016/j.gie.2021.11.038. Epub 2021 Dec 8.
- Background: PubMed 20189503Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
- Background: PubMed 36769545Kovacs N, Pecsi D, Sipos Z, Farkas N, Foldi M, Hegyi P, Bajor J, Eross B, Marta K, Miko A, Rakonczay Z Jr, Sarlos P, Abraham S, Vincze A. Suprapapillary Biliary Stents Have Longer Patency Times than Transpapillary Stents-A Systematic Review and Meta-Analysis. J Clin Med. 2023 Jan 23;12(3):898. doi: 10.3390/jcm12030898.
- Background: PubMed 16650540Okamoto T, Fujioka S, Yanagisawa S, Yanaga K, Kakutani H, Tajiri H, Urashima M. Placement of a metallic stent across the main duodenal papilla may predispose to cholangitis. Gastrointest Endosc. 2006 May;63(6):792-6. doi: 10.1016/j.gie.2005.05.015.
- Background: PubMed 35989132Keulen AV, Gaspersz MP, van Vugt JLA, Roos E, Olthof PB, Coelen RJS, Bruno MJ, van Driel LMJW, Voermans RP, van Eijck CHJ, van Hooft JE, van Lienden KP, de Jonge J, Polak WG, Poley JW, Pek CJ, Moelker A, Willemssen FEJA, van Gulik TM, Erdmann JI, Hol L, IJzermans JNM, Buttner S, Koerkamp BG. Success, complication, and mortality rates of initial biliary drainage in patients with unresectable perihilar cholangiocarcinoma. Surgery. 2022 Dec;172(6):1606-1613. doi: 10.1016/j.surg.2022.06.028. Epub 2022 Aug 18.
- Background: PubMed 24982670Ipek S, Alper E, Cekic C, Cerrah S, Arabul M, Aslan F, Unsal B. Evaluation of the effectiveness of endoscopic retrograde cholangiopancreatography in patients with perihilar cholangiocarcinoma and its effect on development of cholangitis. Gastroenterol Res Pract. 2014;2014:508286. doi: 10.1155/2014/508286. Epub 2014 May 27.
- Background: PubMed 36372281Vogel A, Bridgewater J, Edeline J, Kelley RK, Klumpen HJ, Malka D, Primrose JN, Rimassa L, Stenzinger A, Valle JW, Ducreux M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127-140. doi: 10.1016/j.annonc.2022.10.506. Epub 2022 Nov 10. No abstract available.
- Background: PubMed 34023067Qumseya BJ, Jamil LH, Elmunzer BJ, Riaz A, Ceppa EP, Thosani NC, Buxbaum JL, Storm AC, Sawhney MS, Pawa S, Naveed M, Lee JK, Law JK, Kwon RS, Jue TL, Fujii-Lau LL, Fishman DS, Calderwood AH, Amateau SK, Al-Haddad M, Wani S. ASGE guideline on the role of endoscopy in the management of malignant hilar obstruction. Gastrointest Endosc. 2021 Aug;94(2):222-234.e22. doi: 10.1016/j.gie.2020.12.035. Epub 2021 May 20.
- Background: PubMed 27326319Boulay BR, Birg A. Malignant biliary obstruction: From palliation to treatment. World J Gastrointest Oncol. 2016 Jun 15;8(6):498-508. doi: 10.4251/wjgo.v8.i6.498.
- Individual participant dataSharing planned: Undecided. Question asked to the ethics committee, decision is still pending.
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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.
Andrea Ruzzenente, Professor principal investigator
Integrated University Hospital Verona
Stefano Francesco Crinò, Consultant study director
Integrated University Hospital Verona
Edoardo Poletto, PhD Candidate, Consultant study chair
Integrated university Hospital Verona
Questions about this trial
What is this clinical trial studying?
A study testing ERCP with suprapapillary stent placement and ERCP with transpapillary stent placement in people with Biliary Disease Tract and Biliary Stenosis, run by Azienda Ospedaliera Universitaria Integrata Verona.
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 6 inclusion and 5 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Andrea Ruzzenente, Professor (+39 0458124644, andrea.ruzzenente@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Stent disfunction (time frame: From index procedure to a minimum of one year of follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07325877, which also lists 16 linked publications.
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 8 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.