CholangiocarcinomaSMART-BNCT07558304
Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)
A study testing Percutaneous transpapillary internal-external biliary drainage and Percutaneous suprapapillary biliary drainage with self-expanding metal stent in people with Cholangiocarcinoma and Bile Duct Neoplasms, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial summary
Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Bile Duct Neoplasms, Malignant Biliary Obstruction
- What is being tested?
- Percutaneous transpapillary internal-external biliary drainage and Percutaneous suprapapillary biliary drainage with self-expanding metal stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesBrazil
- Study dates
- 24 Jun 2026to 31 Dec 2028
- Phase
- Interventional
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
- Age >18 years.
- Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion.
- Total bilirubin > 3 mg/dL.
- Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition.
- Patients with potentially resectable neoplasms, defined as the possibility of achieving complete resection (R0), who meet at least one of the following criteria:
- 5.1 Estimated future liver remnant <40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage.
- 5.2 Prolonged jaundice with total bilirubin >10 mg/dL for more than 14 days. 5.3 Malnutrition, defined as ≥10% unintentional weight loss or albumin <3 g/dL, presumably attributable to cholestasis.
- 5.4 Indication for neoadjuvant chemotherapy.
Who cannot join
- Tumor with distal extension to the duodenal papilla, precluding suprapapillary drainage.
- Prior biliary drainage procedure, either percutaneous (PTBD) or endoscopic (ERCP).
- Acute cholangitis, clinically defined as fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³).
- Uncorrectable coagulopathy.
- Iodinated contrast allergy not amenable to desensitization.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Cleber R. P. Kruel, Professor, +55(51)3359-8232 ext. 8232, crkruel@hcpa.edu.br
Gabriel L. da Silva, Attending Physician, +55(51)3359-8232 ext. 8232, gablsilva@hcpa.edu.br
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90610-910
HCPA, +55(51) 3359-8000, flemanski@hcpa.edu.br
About this study
Official title: Randomized Clinical Trial of Suprapapillary Drainage With Metal Stent vs. Routine Internal-External Transpapillary Drainage in Patients With Malignant Hilar Biliary Obstruction
Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver function. To relieve the obstruction, doctors commonly perform procedures to drain bile and restore its flow.
There are different techniques available for biliary drainage. One common method is percutaneous transpapillary internal-external drainage, in which a catheter is placed through the liver and across the natural opening of the bile duct into the intestine. Another approach is percutaneous suprapapillary drainage using a self-expanding metal stent, which allows bile to drain without crossing into the intestine and may reduce the risk of contamination and infection.
Read more
Currently, there is no clear consensus on which of these two techniques is safer or more effective for patients with malignant proximal biliary obstruction. Some studies suggest that avoiding manipulation of the intestinal opening of the bile duct may reduce complications such as infection, but high-quality comparative evidence is lacking.
The purpose of this study is to compare percutaneous suprapapillary drainage with a self-expanding metal stent versus routine percutaneous transpapillary internal-external drainage in patients with malignant proximal biliary obstruction. The study aims to compare the rate of drainage-related complications between the two techniques, as well as to evaluate treatment success, stent patency, and the need for reintervention. In addition, in patients with potentially resectable disease undergoing preoperative biliary drainage, the study will assess and compare surgical outcomes between the two approaches. The results of this study may help determine the safest and most effective drainage strategy for these patients and improve future clinical decision-making.
Read the detailed description
Malignant hilar biliary obstruction is most commonly associated with perihilar cholangiocarcinoma and represents a complex clinical condition characterized by impaired bile flow at or above the hepatic duct confluence. The resulting cholestasis may lead to progressive hepatic dysfunction, increased risk of infectious complications, and reduced tolerance to systemic or surgical therapies. In selected patients, preoperative biliary drainage is performed to optimize liver function and reduce perioperative risk prior to major hepatectomy.
Percutaneous biliary drainage is widely used in this setting due to its ability to selectively decompress specific hepatic segments, particularly in complex hilar strictures. The conventional approach consists of transpapillary internal-external drainage, in which a catheter is advanced across the obstruction and through the papilla into the duodenum. While effective in achieving biliary decompression, this technique may disrupt the function of the sphincter of Oddi and facilitate duodenobiliary reflux, which has been implicated as a potential mechanism for infectious complications.
Percutaneous suprapapillary drainage with placement of a self-expanding metal stent represents an alternative strategy. By avoiding transpapillary manipulation, this approach preserves sphincter function and may reduce bacterial contamination of the biliary tree. Early clinical data suggest a favorable safety profile, particularly regarding infectious outcomes; however, direct comparisons with conventional transpapillary drainage remain limited, and available studies are constrained by methodological limitations.
An additional area of uncertainty relates to patients with potentially resectable disease. In this subgroup, the choice of drainage technique may influence not only peri-procedural outcomes but also subsequent surgical management. Concerns have been raised regarding the potential impact of metallic stents on operative complexity and resectability, although robust data are lacking.
This randomized clinical trial is designed to compare two percutaneous drainage strategies within a standardized institutional framework. Patients with an indication for percutaneous biliary drainage will be allocated to receive either transpapillary internal-external drainage or suprapapillary drainage with a self-expanding metal stent. The study includes both patients with unresectable disease and those with potentially resectable malignancies, allowing for evaluation across different clinical scenarios.
All procedures will be performed by experienced interventional radiologists using uniform technical protocols, and patients will be managed according to institutional standards of care. Follow-up will include clinical, laboratory, and imaging assessment as appropriate to routine practice.
The study is designed to generate comparative evidence regarding the safety and performance of these two techniques. In addition, a prespecified subgroup analysis will focus on patients with potentially resectable cholangiocarcinoma undergoing preoperative biliary drainage, in order to explore the impact of drainage strategy on subsequent surgical outcomes.
- Being tested
- Percutaneous transpapillary internal-external biliary drainage, Percutaneous suprapapillary biliary drainage with self-expanding metal stent
- Keywords
- Cholangiocarcinoma, Percutaneous biliary drainage, Self-expanding metal stent, Suprapapillary drainage, Malignant hilar biliary obstruction, Malignant Biliary Obstruction
- Medical subject headings
- Cholangiocarcinoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transpapillary internal-external biliary drainageProcedure or surgery
Also called Intervention 1
Percutaneous biliary drainage performed by advancing a catheter across the biliary obstruction and through the papilla into the duodenum, allowing internal and external bile drainage.
Percutaneous suprapapillary biliary drainage with self-expanding metal stentProcedure or surgery
Also called Intervention 2
Percutaneous biliary drainage performed by placing a self-expanding metal stent across the biliary obstruction without crossing the papilla.
| Study group | Role | What they receive |
|---|---|---|
| Transpapillary internal-external drainage | Active comparator | Participants undergo percutaneous transpapillary internal-external biliary drainage with placement of a catheter across the obstruction and through the papilla into the duodenum, according to standard institutional practice. Receives: Procedure: Percutaneous transpapillary internal-external biliary drainage |
| Suprapapillary Self-Expanding Metal Stent Drainage | Active comparator | Participants undergo percutaneous suprapapillary biliary drainage with placement of a self-expanding metal stent across the obstruction without crossing the papilla. Receives: Procedure: Percutaneous suprapapillary biliary drainage with self-expanding metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute cholangitis
Defined by clinical criteria, including fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³), in the absence of another infectious source on abdominal and chest imaging.
Measured: Within 90 days after intervention
Acute cholecystitis
Defined by radiological evidence of cholecystitis associated with fever (axillary temperature >38°C) and leukocytosis (white blood cell count >10,000/mm³).
Measured: Within 90 days after intervention
Acute pancreatitis
Defined by the presence of at least two of the following criteria: abdominal pain consistent with pancreatitis, elevation of amylase and/or lipase greater than three times the upper limit of normal, or characteristic imaging findings.
Measured: Within 90 days after intervention
Bile leak
Defined as intra-abdominal bile leakage due to biliary perforation or at the hepatic puncture site, confirmed by imaging.
Measured: Within 90 days after intervention
Hemorrhage
Defined as clinical or radiological evidence of bleeding requiring blood transfusion or reintervention.
Measured: Within 90 days after intervention
Secondary outcomes (3)
Therapeutic success
Defined as a decrease in total bilirubin to <3 mg/dL or a reduction of more than 50% compared to pre-drainage levels
Measured: Within 30 days after intervention
Mortality
All-cause mortality following biliary drainage.
Measured: Within 90 days after intervention
Need for reintervention
Requirement for additional percutaneous or endoscopic procedures
Measured: Within 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start24 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies 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
- Patients who meet the inclusion criteria and do not meet any exclusion criteria will be divided into two clinical groups: Group A: Patients with potentially resectable neoplasms who meet criteria for biliary drainage as defined in the inclusion criteria. Group B: Patients who are not candidates for potentially curative surgical resection. Patients from both clinical groups will be randomized into two intervention groups: Intervention 1: Transpapillary internal-external drainage with a plastic catheter. Intervention 2: Suprapapillary drainage with a self-expanding metal stent.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cleber R. P. Kruel, Professor, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558304
- Sponsor's protocol ID
- 2025-0661
- Other IDs
- 95412526.6.0000.5327
- Acronym
- SMART-B
- Status last verified
- Sep 2026
- First submitted
- 16 Apr 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Publications
Coelen RJS, Roos E, Wiggers JK, Besselink MG, Buis CI, Busch ORC, Dejong CHC, van Delden OM, van Eijck CHJ, Fockens P, Gouma DJ, Koerkamp BG, de Haan MW, van Hooft JE, IJzermans JNM, Kater GM, Koornstra JJ, van Lienden KP, Moelker A, Damink SWMO, Poley JW, Porte RJ, de Ridder RJ, Verheij J, van Woerden V, Rauws EAJ, Dijkgraaf MGW, van Gulik TM. Endoscopic versus percutaneous biliary drainage in patients with resectable perihilar cholangiocarcinoma: a multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):681-690. doi: 10.1016/S2468-1253(18)30234-6. Epub 2018 Aug 17.
PubMed 30122355Zhao XQ, Dong JH, Jiang K, Huang XQ, Zhang WZ. Comparison of percutaneous transhepatic biliary drainage and endoscopic biliary drainage in the management of malignant biliary tract obstruction: a meta-analysis. Dig Endosc. 2015 Jan;27(1):137-45. doi: 10.1111/den.12320. Epub 2014 Sep 24.
PubMed 25040581Wiggers JK, Groot Koerkamp B, Cieslak KP, Doussot A, van Klaveren D, Allen PJ, Besselink MG, Busch OR, D'Angelica MI, DeMatteo RP, Gouma DJ, Kingham TP, van Gulik TM, Jarnagin WR. Postoperative Mortality after Liver Resection for Perihilar Cholangiocarcinoma: Development of a Risk Score and Importance of Biliary Drainage of the Future Liver Remnant. J Am Coll Surg. 2016 Aug;223(2):321-331.e1. doi: 10.1016/j.jamcollsurg.2016.03.035. Epub 2016 Apr 5.
PubMed 27063572Shim DJ, Gwon DI, Han K, Kim Y, Ko GY, Shin JH, Ko HK, Kim JH, Kim JW, Yoon HK, Sung KB. Percutaneous Metallic Stent Placement for Palliative Management of Malignant Biliary Hilar Obstruction. Korean J Radiol. 2018 Jul-Aug;19(4):597-605. doi: 10.3348/kjr.2018.19.4.597. Epub 2018 Jun 14.
PubMed 29962866Ribero D, Zimmitti G, Aloia TA, Shindoh J, Fabio F, Amisano M, Passot G, Ferrero A, Vauthey JN. Preoperative Cholangitis and Future Liver Remnant Volume Determine the Risk of Liver Failure in Patients Undergoing Resection for Hilar Cholangiocarcinoma. J Am Coll Surg. 2016 Jul;223(1):87-97. doi: 10.1016/j.jamcollsurg.2016.01.060. Epub 2016 Feb 13.
PubMed 27049784Qumseya 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 34023067Pietrzak J, Przybylkowski A. Endoscopic Treatment of Malignant Hilar Biliary Obstruction. Cancers (Basel). 2023 Dec 13;15(24):5819. doi: 10.3390/cancers15245819.
PubMed 38136363Elmunzer BJ, Smith ZL, Tarnasky P, Wang AY, Yachimski P, Banovac F, Buscaglia JM, Buxbaum J, Chak A, Chong B, Cote GA, Draganov PV, Dua K, Durkalski V, Geller BS, Jamil LH, Keswani RN, Khashab MA, Law R, Lo SK, McCarthy S, Selby JB, Singh VK, Taylor JR, Willingham FF, Spitzer RL, Foster LD; INTERCPT study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1282-1284. doi: 10.1016/j.cgh.2020.05.035. Epub 2020 May 23.
PubMed 32454259Pavlidis 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 29428098Okamoto 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 16650540Mullen JT, Ribero D, Reddy SK, Donadon M, Zorzi D, Gautam S, Abdalla EK, Curley SA, Capussotti L, Clary BM, Vauthey JN. Hepatic insufficiency and mortality in 1,059 noncirrhotic patients undergoing major hepatectomy. J Am Coll Surg. 2007 May;204(5):854-62; discussion 862-4. doi: 10.1016/j.jamcollsurg.2006.12.032. Epub 2007 Feb 15.
PubMed 17481498Luman W, Cull A, Palmer KR. Quality of life in patients stented for malignant biliary obstructions. Eur J Gastroenterol Hepatol. 1997 May;9(5):481-4. doi: 10.1097/00042737-199705000-00013.
PubMed 9187881Liu JG, Wu J, Wang J, Shu GM, Wang YJ, Lou C, Zhang J, Du Z. Endoscopic Biliary Drainage Versus Percutaneous Transhepatic Biliary Drainage in Patients with Resectable Hilar Cholangiocarcinoma: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2018 Sep;28(9):1053-1060. doi: 10.1089/lap.2017.0744. Epub 2018 Mar 12.
PubMed 29641365Hameed 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 27154803Franssen S, Rousian M, van Verschuer V, Bruno M, Doukas M, van Driel L, Homs M, Mohseny B, de Wilde R, de Jonge J, Polak W, Porte R, Bijdevaate D, Moelker A, Groot Koerkamp B. Primary percutaneous stenting for palliative biliary drainage of patients with malignant hilar biliary obstruction: TESLA trial. JHEP Rep. 2025 Sep 11;7(11):101541. doi: 10.1016/j.jhepr.2025.101541. eCollection 2025 Nov.
PubMed 41113121