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)

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.

 

MissingLinkText

Conflicts of Interest

Authors do not have any conflict of interest to disclose.

• 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
• 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
• 3 Black N.. Why we need observational studies to evaluate the effectiveness of health care. BMJ 1996; 312: 1215-1218
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 21 Minaga K., Kitano M.. Recent advances in endoscopic ultrasound-guided biliary drainage. Dig Endosc 2018; 30 (01): 38-47
• 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
• 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
• 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
• 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
• 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
• 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
• 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.
• 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
• 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
• 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
• 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
• 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
• 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
• 35 Sundaram S., Dhir V.. EUS-guided biliary drainage for malignant hilar biliary obstruction: A concise review. Endosc Ultrasound 2021; 10 (03): 154-160
• 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
• 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
• 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
• 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].
• 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
• 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

Publication History

Article published online:
27 March 2025