Introduction
It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing metal stents (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency.
Aims & Methods
The aim is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (CDS-type) for the management of distal malignant biliary obstruction. This is a multicentre, open-label, randomised controlled trial with two parallel groups. The primary endpoint was the rate of recurrent biliary obstruction (RBO), as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin >50% within 14days), adverse events, and others.
Results
Between November-2020 and October-2022, 123 patients (pancreatic cancer 85%, palliative status 80%) were screened and 84 with malignant biliary obstruction, and underwent EUS-CDS (rescue after failed ERCP, 62%), were randomised: 44 patients in LAMS group and 40 in LAMS-DPS group. The rate of RBO (29.5 vs 10%; OR 0.26 [IC95% 0.07–0.83],p=0.04) was lower, but with a longer procedure time (30 vs 20-min, p=0.02), in LAMS-DPS-group. Furthermore, less biliary reinterventions (12.5 vs 20.5%, p=0.38), longer time-to-RBO (155.5 vs 51.5 days, p=0.10), and shorter hospital stay (6 vs. 8.5,p=0.06) were encountered in LAMS-DPS group. No differences were found between technical (97 vs. 88%), clinical success (92 vs. 88.8%) and AEs (22.5 vs.11.4%). NCT04595058 ClinicalTrials.gov
Table1: Outcomes (RBO, recurrent biliary obstruction; BRI, biliary reinterventions).
| | N – 84 | LAMS (N-44) | LAMS-Pigtail (N-40) | OR | p |
| RBO, n (%) | 17 (20.2) | 13 (29.5) | 4 (10) | 0.06(0.07-0.83) | 0.04 |
| BRI, n (%) | 14 (16.7) | 9 (20.5) | 5 (12.5) | 0.98(0.67-1.98) | 0.38 |
| Technical success,% | 78 (92.9) | 39 (88.6) | 39 (97.5) | - | 0.20 |
| Clinical Success,% | 75 (90.5) | 39 (88.6) | 37 (92.5) | - | 0.71 |
| Hospital stay, days | 5.1(3-15.5) | 8.5 (4.25-15.5) | 6 (3-10) | - | 0.06 |
| Adverse Events, n | 14 (16.1) | 5 (11.4) | 9 (22.5) | - | 0.243 |
| Related-AEs, n | 10 (13.1) | 3 (6.8) | 8 (20.0) | - | 0.11 |
Conclusion
This trial confirms that CDS with LAMS is an effective technique. The technical strategy of placing a pigtail within the LAMS is associated with a lower risk of RBO, and a non-significant trend of shorter hospital stay.
References
1-Garcia-Sumalla, A., Loras, C., Sanchiz, V. et al. Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction—BAMPI TRIAL: an open-label, randomized controlled trial protocol. Trials 2022; 23:181
2-Gornals JB, Consiglieri CF, Bergamino MA. Double pigtail for preventing ascending cholangitis after endoscopic ultrasonography-guided choledochoduodenostomy with lumen-apposing metal stent. Dig Endosc. 2016;28:100.
3-Garcia-Sumalla A, Loras C, Guarner-Argente C, et al. Is a coaxial plastic stent within a lumen-apposing metal stent useful for the management of distal malignant biliary obstruction? Surg Endosc. 2021;35:4873 –81
Disclosure
- A Garcia-Sumalla is a PhD student at the Faculty of Medicine and Health Sciences, University of Barcelona, and this paper is part of his doctoral project.
- Joan B Gornals acts as a PhD Director; is a consultant for Boston Scientific and has received a research grant from this company.
- Manuel Pérez-Miranda is a consultant and speaker for Medtronic, Olympus, Taewoong, and M.I.Tech.
- Enrique Vazquez-Sequeiros is a consultant for Boston Scientific.
Jose Ramon Aparicio is a consultant for Boston Scientific