Sixty-two patients had a Kaffes stent inserted, mean age of 53 (SD 11.9, range 13–72) years; 1 patient had a living-related donor right lobe graft; of the remainder 68% were DBD (donation after brain death) grafts. The mean CIT (cold ischaemic time) was 8.4 hours (± 2.4) for the DBD group and 8.9 (± 2.5) for the DCD (donation after circulatory death) group (Table 1). The aetiologies for liver disease are shown in Table 2. 13 (21%) patients had previous plastic stenting and 1 patient had had the traditional type of longer-length FCSEMS (Wallflex™, Boston Scientific) without stricture resolution. The mean time between the transplant and Kaffes insertion was 41 months (SD 72, range 3 days − 327 months). 38 patients had balloon dilatations of strictures prior to stent insertion. 29 had a sphincterotomy at the time of stent insertion, whilst another patient had had a previous sphincterotomy.
Table 1
Highlights the main outcomes and specific factors of the Kaffes stent. DBD: Donation after brain death; CIT: Cold ischaemic time. * One patient died of frailty post-transplant 13 months after a Kaffes stent successfully resolved the stricture and another was re-transplanted for chronic rejection so for the purpose of this study, both were not included in the analysis for long-term stricture resolution.
No. of patients inserted | 62 |
No. of patients removed | 56 |
Immediate Stricture resolution | 54/56 (96%) |
Long-term stricture resolution (%) | 42/52* (81%) |
Complications (%) | 9/62 (15%) |
Biliary reconstruction | 1 |
Mean age (years) | 53 |
Females (%) | 26 (42%) |
Symptomatic (%) | 16 (26%) |
DBD (%) | 36/53 (68%) |
CIT (Hours) (± SD) | 8.6 (2.4) |
Table 2
The aetiologies of liver disease for patients stented. HCC: Hepatocellular carcinoma; Non-alcoholic steatohepatitis; PFIC: Primary Familial intrahepatic cholestasis.
Aetiology | FCSEMS | Aetiology | FCSEMS |
Alcoholic liver disease | 14 | Drug-induced liver failure | 1 |
Hepatitis C | 4 | Primary Hyperoxaluria | 2 |
Primary biliary cirrhosis | 4 | Cystic Fibrosis related cirrhosis | 1 |
Budd Chiari | 3 | NASH | 4 |
Autoimmune hepatitis | 3 | Polycystic | 2 |
Hepatitis B | 2 | PFIC | 1 |
HCC | 12 | PSC | 1 |
Acute liver failure, cause unknown | 4 | Paracetamol toxicity | 3 |
Wilson’s disease | 1 | | |
Immediate stricture resolution (Fig. 2)
To date, 56 patients have had their Kaffes stent removed, of whom 54 (96%) had immediate stricture resolution at the time of stent removal. There was no relationship between stent size, balloon dilatations (N = 33, P = 1.00) and/or sphincterotomies (N = 26, P = 1.00) and stricture resolution. Of the 2 patients in whom the Kaffes stent had failed to resolve stricturing, 1 went onto have stricture resolution with a plastic stent insertion, whilst the other had a traditional longer-type of FCSEMS inserted, both without successful stricture resolution.
Of the 54 patients in whom there was immediate stricture resolution, 1 died of frailty a year after transplant and another was re-transplanted due to chronic rejection, both having no relationship to their initial anastomotic stricture; these patients were excluded from the overall analysis.
Long-term stricture resolution
Overall, 42/52 (81%) patients went onto have long-term stricture resolution with no recurrence (mean follow-up period was 548 days (SD 256, range 13-1097 days). Of the 10 patients who had recurrence (mean time to recurrence was 224 days (SD 200, range 37–575 days), 1 patient became jaundice 3 months after stent removal, but instead of further stenting, a sphincterotomy was enough to improve drainage. 9 had asymptomatic recurrence on imaging (5 with cholestatic LFTs), of whom 5 had a further Kaffes placed, 1 had the traditional FCSEMS placement, another improved with sphincterotomy. Only 1 patient required biliary reconstruction as at their ERCP, the wire failed to pass through the stricture.
Improvement in symptoms
Forty-six patients were asymptomatic with an anastomotic stricture on imaging (18 with cholestatic LFTs). 16 patients were symptomatic (6 jaundiced, 4 pruritic, 6 cholangitic). Of these, symptoms resolved in 13 (3 jaundiced, 4 pruritic, 6 cholangitic). Of the 3 patients who also continued to be jaundice after stent insertion, 2 had their stent removed within 4 weeks of insertion, the 3rd after 86 days; all 3 were found to have stricture resolution. Two of these patients were found to have papillary stenosis and improved after sphincterotomy; the other patient required re-transplantation due to chronic rejection. Overall, there was a significant improvement in patients’ LFTs following stent insertion (see Table 3).
Table 3
The mean and range of LFTs in patients before stent insertion compared to after removal in patients where stricture had resolved. LFTs: Liver function tests; SD: Standard deviation.
LFTs | Mean before stent (SD) | Range before | Mean after stent (SD) | Range after | P value |
GGT (IU/L) | 513 (538) | 13-2008 | 193 (320) | 11-2154 | < 0.01 |
AST (IU/L) | 101 (179) | 13-1070 | 41.4 (32.1) | 9-175 | 0.03 |
ALP (IU/L) | 313 (322) | 42-2088 | 169 (109) | 58–622 | < 0.01 |
Bili (µmol/L) | 26.7 (46.1) | 3-305 | 14.0 (13.6) | 4–70 | 0.03 |
Complications
Overall, 9 (15%) of the 62 patients had a complication: 3 patients developed pancreatitis after the Kaffes stent insertion, 4 developed cholangitis, 1 after insertion and 3 following stent removal, 1 patient had a wire-guided perforation of the bile duct without complication, 1 had the retrieval wires uncoil. There was no associated mortality.
Of the stents that were removed at the time of writing, all were removed successfully (mean of 114 days (SD 70), range 3-345 days), although as above, 1 stent needed 2 attempts because the removal wires uncoiled. Stent removal for a patient 345 days after insertion was delayed due to pregnancy; the stent was removed easily without complications.