Cost analysis of a long-term randomized controlled study in biliary duct-to-duct anastomotic stricture after liver transplantation
Multiple plastic stent (MPS) for biliary anastomotic stricture (AS) after liver transplantation requires multiple procedures with consequent costs. To compare the success, adverse events and treatment-related costs of fully covered self-expandable metal stents (FCSEMS) versus MPS. Thirty liver transplant (LT) patients with clinically relevant naïve AS were prospectively randomized to FCSEMS or MPS, with stent numbers increased at 3-month intervals. Treatment costs per patient were calculated for endoscopic retrograde cholangiopancreatography (including all devices and stents) and overall hospital stay. Radiological success was achieved in 73% of FCSEMS (median indwelling period of 6 mos) and 93% of MPS patients (P = NS) (median period of 11 mos). AS recurrence occurred in 36% of FCSEMS and 7% of MPS patients (P = NS), and AS re-treatment was needed in 53% and 13% (P < 0.01), respectively, during follow-up of 60 (34-80) months. Stents migrated after 29% and 2.6% of FCSEMS and MPS procedures, respectively (P < 0.01). Including re-treatments, long-term clinical success was achieved in 28/30 (93%) patients. Overall treatment-related costs were similar between groups. In the subgroup of LT patients in clinical remission after first-line treatment, treatment costs were 41% lower per FCSEMS patient compared with MPS patients. FCSEMS did not perform better than MPS. FCSEMS migration increased the rate of re-treatment and costs.
CET Conclusion
| Reviewer: | Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford |
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| Conclusion: | This paper reports a cost-analysis from a randomised controlled trial in biliary stenting. Much of the crucial information about the study is written into a previous publication (Tal et al 2017) and not reproduced here. This paper represents the results of a subgroup of patients operated at one centre (30/58 patients). The study was previously assessed as being of good quality by our expert reviewer, although there was no blinding, which is a potential source of bias. Anastomotic strictures recurred in more metal-stent patients, with more stent migration than plastic-stent patients. This meant that, overall, there was a similar cost to achieve resolution of the condition in both arms, but the study was small and possibly underpowered. |
Methodological quality
| Jadad score | 3 |
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| Allocation concealment | NO |
| Data analysis | STRICT INTENTION TO TREAT |
Study Details
| Aims: | This study aimed to compare the effectiveness, treatment-related costs and adverse events of treating anastomotic stricture (AS) with fully covered self-expandable metal stents (FCSEMS) versus multiple plastic stent (MPS) following liver transplantation |
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| Interventions: | Patients were randomised to either the FCSEMS group or the MPS group. |
| Participants: | 30 liver transplant patients with duct-to-duct AS. |
| Outcomes: | The outcomes of interest were treatment success, adverse events and a cost analysis. The cost analysis included the total cost of endoscopic therapy and hospitalisation for procedures and dealing with adverse events. |
| Follow Up: | Median (range): 60 (34–80) months |
Metadata
| Funding: | No funding was received for this study |
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| Publication type: | Randomized Controlled Trial, Randomised Controlled Trial |
| Organ: | Liver |
| Language: | English |
| Author email: | paolo.cantu@policlinico.mi.it |
| MeSH terms: | Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Constriction, Pathologic; Health Care Costs; Humans; Liver Transplantation; Self Expandable Metallic Stents; Stents; Treatment Outcome; TRIAL REGISTRATION - ClinicalTrials.Gov - NCT01393067 |