Endoscopy 2025; 57(S 02): S6-S8
DOI: 10.1055/s-0045-1805102
Abstracts | ESGE Days 2025
Best abstracts
ESGE Presidential Session 03/04/2025, 14:30 – 16:30 Room 117+116

Percutaneous transhepatic biliary drainage versus endoscopic ultrasound-guided biliary drainage with intended primary metal stent for malignant distal biliary obstruction: a European prospective controlled multicentre trial (PUMa trial)

D Schmitz
1   Department of Gastroenterology, Helios Kliniken Schwerin and Medical School Hamburg, Schwerin, Germany
2   Department of Gastroenterology, Theresienkrankenhaus und St-Hedwigklinik, Mannheim, Germany
,
J B Gornals
3   Bellvitge University Hospital, L'Hospitalet de Llobregat. Barcelona, Spain
,
J J Vila
4   Hospital Universitario de Navarra – Department of Gastroenterology and Hepatology, Pamplona, Spain
,
A Schmidt
5   Department of Medicine II, University Hospital Freiburg, Freiburg, Germany
6   Department of Gastroenterology, Hepatology and Endocrinology, Robert-Bosch-Krankenhaus, Stuttgart, Germany
,
T Kleemann
7   Department of Gastroenterology and Rheumatology, Carl-Thiem-Klinikum Cottbus, Cottbus, Germany
,
J R Aparicio
8   General University Hospital of Alicante, Alicante, Spain
,
A Amanzada
9   University Medicine Göttingen, Göttingen, Germany
,
M Dollhopf
10   München Klinik Neuperlach, München, Germany
,
E Redondo-Cerezo
11   Virgen de las Nieves University Hospital, Granada, Spain
,
J Weigt
12   University Hospital Magdeburg, Magdeburg, Germany
,
T Voigtländer
13   Hannover Medical School, Hannover, Germany
,
T von Hahn
14   Asklepios Klinik Barmbek, Hamburg, Germany
,
J Rudi
2   Department of Gastroenterology, Theresienkrankenhaus und St-Hedwigklinik, Mannheim, Germany
,
C V Tortosa
2   Department of Gastroenterology, Theresienkrankenhaus und St-Hedwigklinik, Mannheim, Germany
,
A Küllmer
5   Department of Medicine II, University Hospital Freiburg, Freiburg, Germany
,
M Perez-Miranda
15   Department of Gastrointestinal Endoscopy, Hospital Universitario Río Hortega, Valladolid, Spain
› Author Affiliations
› Further Information
Also available at
 

Aims Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been associated with better clinical outcomes and a lower rate of adverse events than fluoroscopically guided percutaneous transhepatic biliary drainage (PTBD) in recent retrospective studies. However, both procedures have not yet been compared in a prospective sufficiently powered multicentre international study in adult patients with distal malignant bile duct obstruction undergoing primary metal stenting after unsuccessful ERCP.

Methods The study protocol (PMID: 36302047) was designed as a non-inferiority, non-randomised, controlled, European multicentre study with two parallel groups. Each of the 14 centres in Spain and Germany used the intervention with the highest level of competence (US-guided PTBD or EUS-guided transmural BD) as an intended one step-procedure with primary metal stenting (NCT03546049).

Results Two hundred and twelve patients were recruited from December 2018 to August 2024 at five PTBD and 9 EUS-BD centres, resulting in 68 PTBDs and 141 EUS-BDs, respectively (60 EUS-HGS, 59 EUS-CDS, 17 EUS-AGS, and 5 EUS-Rendezvous with ERCP). The baseline characteristics of the patients (mean age: 73 years) were comparable with pancreatic cancer as the main cause of distal malignant bile duct obstruction (63.6%) and gastric outlet obstruction (49.3%) as the main cause of unsuccessful ERCP. Mean procedure time (58.0 vs. 44.0 minutes) and hospital stay after initial procedure (9.4 vs. 7.5 days) were longer for PTBD than for EUS-BD. Technical success (97.2 vs. 91.2%) and clinical success in the ITT analysis (76.3 vs. 70.6%) were better in EUS-BD than in PTBD, except in the subgroup of EUS-HGS, where the clinical success rate was similar to PTBD. The overall rate of adverse events (grade 1-4) was similar in both groups (13.2% in PTBD vs. 16.3% in EUS-BD), including 6 fatal adverse events (death). There was no significant increase in pain scores (VAS) in either arm. Six-month follow-up data pending [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23] [24] [25] [26] [27] [28] [29] [30] [31] [32] [33] [34] [35] [36] [37] [38] [39] [40] [41].

Conclusions EUS-BD (EUS-HGS, EUS-CDS, EUS-AGS and EUS-Rendezvous with ERCP) showed overall slightly better technical and clinical success than PTBD for distal malignant biliary obstruction with intended primary metal stenting, except for EUS-HGS in the subgroup analysis. The rate of adverse events was similar for both procedures.



Publication History

Article published online:
27 March 2025

© 2025. European Society of Gastrointestinal Endoscopy. All rights reserved.

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

  • References

  • 1 Artifon E.L., Aparicio D., Paione J.B., Lo S.K., Bordini A., Rabello C., Otoch J.P., Gupta K.. Biliary drainage in patients with unresectable, malignant obstruction where ERCP fails: endoscopic ultrasonography-guided choledochoduodenostomy versus percutaneous drainage. J Clin Gastroenterol 2012; 46 (09): 768-774
    CrossrefPubMedSearch in Google Scholar
  • 2 Bapaye A., Dubale N., Aher A.. Comparison of endosonography-guided vs. percutaneous biliary stenting when papilla is inaccessible for ERCP. United European. Gastroenterol J 2013; 1 (04): 285-293
    CrossrefPubMedSearch in Google Scholar
  • 3 Black N.. Why we need observational studies to evaluate the effectiveness of health care. BMJ 1996; 312: 1215-1218
    CrossrefPubMedSearch in Google Scholar
  • 4 Cotton P.B., Eisen G.M., Aabakken L., Baron T.H., Hutter M.M., Jacobson B.C., Mergener K., Nemcek A., Petersen B.T., Petrini J.L., Pike I.M., Rabeneck L., Romagnuolo J., Vargo J.J.. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71 (03): 446-454
    CrossrefPubMedSearch in Google Scholar
  • 5 Gerbershagen H.J., Aduckathil S., van Wijck A.J., Peelen L.M., Kalkman C.J., Meissner W.. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology 2013; 118 (04): 934-944
    CrossrefPubMedSearch in Google Scholar
  • 6 Ginestet C., Sanglier F., Hummel V., Rouchaud A., Legros R., Lepetit H., Dahan M., Carrier P., Loustaud-Ratti V., Sautereau D., Albouys J., Jacques J., Geyl S.. EUS-guided biliary drainage with electrocautery-enhanced lumen-apposing metal stent placement should replace PTBD after ERCP failure in patients with distal tumoral biliary obstruction: a large real-life study. Surg Endosc 2022; 36 (05): 3365-3373
    CrossrefPubMedSearch in Google Scholar
  • 7 Giovannini M., Moutardier V., Pesenti C., Bories E., Lelong B., Delpero J.R.. Endoscopic ultrasound-guided bilioduodenal anastomosis: a new technique for biliary drainage. Endoscopy 2001; 33 (10): 898-900 PMID: 11571690
    Thieme ConnectPubMedSearch in Google Scholar
  • 8 Harvey P.R., Baldwin S., Mytton J., Dosanjh A., Evison F., Patel P., Trudgill N.J.. Higher volume providers are associated with improved outcomes following ERCP for the palliation of malignant biliary obstruction. EClinicalMedicine 2020; 18: 100212
    CrossrefPubMedSearch in Google Scholar
  • 9 Heedman P.A., Åstradsson E., Blomquist K., Sjödahl R.. Palliation of Malignant Biliary Obstruction: Adverse Events are Common after Percutaneous Transhepatic Biliary Drainage. Scandinavian Journal of Surgery 2018; 107 (01): 48-53
    CrossrefPubMedSearch in Google Scholar
  • 10 Hindryckx P., Degroote H., Tate D.J., Deprez P.H.. Endoscopic ultrasound-guided drainage of the biliary system: Techniques, indications and future perspectives. World J Gastrointest Endosc 2019; 11 (02): 103-114
    CrossrefPubMedSearch in Google Scholar
  • 11 Isayama H., Nakai Y., Itoi T., Yasuda I., Kawakami H., Ryozawa S., Kitano M., Irisawa A., Katanuma A., Hara K., Iwashita T., Fujita N., Yamao K., Yoshida M., Inui K.. Clinical practice guidelines for safe performance of endoscopic ultrasound/ultrasonography-guided biliary drainage: 2018. J Hepatobiliary Pancreat Sci 2019; 26 (07): 249-269
    CrossrefPubMedSearch in Google Scholar
  • 12 Jacques J., Privat J., Pinard F., Fumex F., Valats J.C., Chaoui A., Cholet F., Godard B., Grandval P., Legros R., Kerever S., Napoleon B.. Endoscopic ultrasound-guided choledochoduodenostomy with electrocautery-enhanced lumen-apposing stents: a retrospective analysis. Endoscopy 2019; 51 (06): 540-547
    Thieme ConnectPubMedSearch in Google Scholar
  • 13 Khashab MA., Valeshabad A.K., Afghani E., Singh VK., Kumbhari V., Messallam A., Saxena P., El Zein M., Lennon AM., Canto MI., Kalloo AN.. A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP. Dig Dis Sci 2015; 60 (02): 557-565
    CrossrefPubMedSearch in Google Scholar
  • 14 Kim J.W., Jeong J.B., Lee K.L., Kim B.G., Ahn D.W., Lee J.K., Kim S.H.. Comparison between uncovered and covered self-expandable metal stent placement in malignant duodenal obstruction. World J Gastroenterol 2015; 21 (05): 1580-7
    CrossrefPubMedSearch in Google Scholar
  • 15 Koito K., Namieno T., Nagakawa T., Morita K.. Percutaneous transhepatic biliary drainage using color Doppler ultrasonography. J Ultrasound Med 1996; 15 (03): 203-6
    CrossrefPubMedSearch in Google Scholar
  • 16 Kozarek R.A.. The society for gastrointestinal intervention. Are we, as an organization of disparate disciplines, cooperative or competitive?. Gut Liver 2010; 4 (Suppl. 01) S1-S8
    CrossrefPubMedSearch in Google Scholar
  • 17 Lee TH., Choi JH., Park DH., Song TJ., Kim DU., Paik WH., Hwangbo Y., Lee SS., Seo DW., Lee SK., Kim MH.. Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction. Clin Gastroenterol Hepatol 2016; 14 (07): 1011-1019
    CrossrefPubMedSearch in Google Scholar
  • 18 Liu Y.S., Lin C.Y., Chuang M.T., Tsai Y.S., Wang C.K., Ou M.C.. Success and complications of percutaneous transhepatic biliary drainage are influenced by liver entry segment and level of catheter placement. Abdom Radiol (NY) 2018; 43 (03): 713-722
    CrossrefPubMedSearch in Google Scholar
  • 19 Mohan B.P., Canakis A., Khan S.R., Chandan S., Ponnada S., McDonough S., Adler D.G.. Drug Eluting Versus Covered Metal Stents in Malignant Biliary Strictures-Is There a Clinical Benefit?: A Systematic Review and Meta-Analysis. J Clin Gastroenterol 2021; 55 (03): 271-27
    CrossrefPubMedSearch in Google Scholar
  • 20 McWilliams R.R., Maisonneuve P., Bamlet W.R., Petersen G.M., Li D., Risch H.A., Yu H., Fontham E.T., Luckett B., Bosetti C., Negri E., La Vecchia C., Talamini R., Bueno de Mesquita H.B., Bracci P., Gallinger S., Neale R.E., Lowenfels A.B.. Risk Factors for Early-Onset and Very-Early-Onset Pancreatic Adenocarcinoma: A Pancreatic Cancer Case-Control Consortium (PanC4) Analysis. Pancreas 2016; 45 (02): 311-316
    CrossrefPubMedSearch in Google Scholar
  • 21 Minaga K., Kitano M.. Recent advances in endoscopic ultrasound-guided biliary drainage. Dig Endosc 2018; 30 (01): 38-47
    CrossrefPubMedSearch in Google Scholar
  • 22 Nakai Y., Sato T., Hakuta R., Ishigaki K., Saito K., Saito T., Takahara N., Hamada T., Mizuno S., Kogure H., Nogchi K., Ito Y., Isayama H., Koike K.. Long-term outcomes of a long, partially covered metal stent for EUS-guided hepaticogastrostomy in patients with malignant biliary obstruction (with video). Gastrointest Endosc 2020; 92 (03): 623-631.e1
    CrossrefPubMedSearch in Google Scholar
  • 23 Paduano D., Facciorusso A., De Marco A., Ofosu A., Auriemma F., Calabrese F., Tarantino I., Franchellucci G., Lisotti A., Fusaroli P., Repici A., Mangiavillano B.. Endoscopic Ultrasound Guided Biliary Drainage in Malignant Distal Biliary Obstruction. Cancers (Basel) 2023; 15 (02): 490
    CrossrefPubMedSearch in Google Scholar
  • 24 Park J.K., Woo Y.S., Noh D.H., Yang J.I., Bae S.Y., Yun H.S., Lee J.K., Lee K.T., Lee K.H.. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc 2018; 88 (02): 277-282
    CrossrefPubMedSearch in Google Scholar
  • 25 Pu L.Z., Singh R., Loong C.K., de Moura E.G.. Malignant Biliary Obstruction: Evidence for Best Practice. Gastroenterol Res Pract 2016; 2016: 1-7
    CrossrefPubMedSearch in Google Scholar
  • 26 Sawas T., Bailey N.J., Yeung K.Y.K.A., James T.W., Reddy S., Fleming C.J., Marya N.B., Storm A.C., Abu Dayyeh B.K., Petersen B.T., Martin J.A., Levy M.J., Baron T.H., Bun Teoh A.Y., Chandrasekhara V.. Comparison of EUS-guided choledochoduodenostomy and percutaneous drainage for distal biliary obstruction: A multicenter cohort study. Endosc Ultrasound 2022; 11 (03): 223-230
    CrossrefPubMedSearch in Google Scholar
  • 27 Schmitz D., Weller N., Doll M., Weingärtner S., Pelaez N., Reinmuth G., Hetjens S., Rudi J.. An Improved Method of Percutaneous Transhepatic Biliary Drainage Combining Ultrasound-Guided Bile Duct Puncture with Metal Stent Implantation by Fluoroscopic Guidance and Endoscopic Visualization as a One-Step Procedure: A Retrospective Cohort Study. J Clin Interv Radiol ISVIR 2018; 02: 135-143
    Thieme ConnectPubMedSearch in Google Scholar
  • 28 Seo D.W., Sherman S., Dua K.S., Slivka A., Roy A., Costamagna G., Deviere J., Peetermans J., Rousseau M., Nakai Y., Isayama H., Kozarek R.. Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial. Gastrointest Endosc 2019; 90 (04): 602-612.e4 Erratum in: Gastrointest Endosc. 2019 Nov;90(5):861, Erratum in: Gastrointest Endosc. 2021 Oct;94(4):880.
    CrossrefPubMedSearch in Google Scholar
  • 29 Sharaiha R.Z., Khan M.A., Kamal F., Tyberg A., Tombazzi C.R., Ali B., Tombazzi C., Kahaleh M.. Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis. Gastrointest Endosc 2017; 85 (05): 904-914
    CrossrefPubMedSearch in Google Scholar
  • 30 Sharaiha R.Z., Kumta N.A., Desai A.P., DeFilippis E.M., Gabr M., Sarkisian A.M., Salgado S., Millman J., Benvenuto A., Cohen M., Tyberg A., Gaidhane M., Kahaleh M.. Endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage: predictors of successful outcome in patients who fail endoscopic retrograde cholangiopancreatography. Surg Endosc 2016; 30 (12): 5500-5505
    CrossrefPubMedSearch in Google Scholar
  • 31 Sharma Z.D., Puri R.. Quality indicators in endoscopic retrograde cholangiopancreatography: a brief review of established guidelines. Clin Endosc 2023; 56 (03): 290-297
    CrossrefPubMedSearch in Google Scholar
  • 32 Shimizu H., Kato A., Takayashiki T., Kuboki S., Ohtsuka M., Yoshitomi H., Furukawa K., Miyazaki M.. Peripheral portal vein-oriented non-dilated bile duct puncture for percutaneous transhepatic biliary drainage. World J Gastroenterol 2015; 21 (44): 12628-12634
    CrossrefPubMedSearch in Google Scholar
  • 33 Speer A.G., Christopher R., Russell G., Hatfield A.R.W., Macrae K.D., Cotton P.B., Mason R.R., Leung J.W.C., Houghton J., Lennon C.A.. Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice. The Lancet 1987; 330 8550 57-62
    CrossrefPubMedSearch in Google Scholar
  • 34 Sportes A., Camus M., Greget M., Leblanc S., Coriat R., Hochberger J., Chaussade S., Grabar S., Prat F.. Endoscopic ultrasound-guided hepaticogastrostomy versus percutaneous transhepatic drainage for malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatography: a retrospective expertise-based study from two centers. Therap Adv Gastroenterol 2017; 10 (06): 483-493
    CrossrefPubMedSearch in Google Scholar
  • 35 Sundaram S., Dhir V.. EUS-guided biliary drainage for malignant hilar biliary obstruction: A concise review. Endosc Ultrasound 2021; 10 (03): 154-160
    CrossrefPubMedSearch in Google Scholar
  • 36 Testoni P.A., Mariani A., Aabakken L., Arvanitakis M., Bories E., Costamagna G., Devière J., Dinis-Ribeiro M., Dumonceau J.M., Giovannini M., Gyokeres T., Hafner M., Halttunen J., Hassan C., Lopes L., Papanikolaou I.S., Tham T.C., Tringali A., van Hooft J., Williams E.J.. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2016; 48 (07): 657-683
    Thieme ConnectPubMedSearch in Google Scholar
  • 37 Tsuchiya T., Teoh A.Y.B., Itoi T., Yamao K., Hara K., Nakai Y., Isayama H., Kitano M.. Long-term outcomes of EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction: a prospective multicenter study. Gastrointest Endosc 2018; 87 (04): 1138-1146
    CrossrefPubMedSearch in Google Scholar
  • 38 Van der Merwe S.W., van Wanrooij R.L.J., Bronswijk M., Everett S., Lakhtakia S., Rimbas M., Hucl T., Kunda R., Badaoui A., Law R., Arcidiacono P.G., Larghi A., Giovannini M., Khashab M.A., Binmoeller K.F., Barthet M., Perez-Miranda M., van Hooft J.E.. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2022; 54 (02): 185-205 Epub 2021 Dec 22
    Thieme ConnectPubMedSearch in Google Scholar
  • 39 Venkatanarasimha N., Damodharan K., Gogna A., Leong S., Too CW., Patel A., Tay KH., Tan BS., Lo R., Irani F.. Diagnosis and Management of Complications from Percutaneous Biliary Tract Interventions. Radiographics 2017; 37 (02): 665-680 Erratum in: Radiographics, 37(3), 1004. Damodharan, Karthik [corrected to Damodharan, Karthikeyan].
    CrossrefPubMedSearch in Google Scholar
  • 40 Wang K., Zhu J., Xing L., Wang Y., Jin Z., Li Z.. Assessment of efficacy and safety of EUS-guided biliary drainage: a systematic review. Gastrointest Endosc 2016; 83 (06): 1218-1227
    CrossrefPubMedSearch in Google Scholar
  • 41 Yokota Y., Fukasawa M., Takano S., Kadokura M., Shindo H., Takahashi E., Hirose S., Kawakami S., Fukasawa Y., Sato T., Enomoto N.. Partially covered metal stents have longer patency than uncovered and fully covered metal stents in the management of distal malignant biliary obstruction: a retrospective study. BMC Gastroenterol 2017; 17 (01): 105
    CrossrefPubMedSearch in Google Scholar