Published online Jul 14, 2016. doi: 10.3748/wjg.v22.i26.6065
Peer-review started: December 24, 2015
First decision: January 28, 2016
Revised: February 2, 2016
Accepted: March 1, 2016
Article in press: March 2, 2016
Published online: July 14, 2016
Processing time: 195 Days and 13.4 Hours
AIM: To determine the impact (morbidity/mortality) of biliary stent-related events (SRE) (cholangitis or stent obstruction) in chemotherapy-treated pancreatico-biliary patients.
METHODS: All consecutive patients with advanced pancreatobiliary cancer and a biliary stent in-situ prior to starting palliative chemotherapy were identified retrospectively from local electronic case-note records (Jan 13 to Jan 15). The primary end-point was SRE rate and the time-to-SRE (defined as time from first stenting before chemotherapy to date of SRE). Progression-free survival and overall survival were measured from the time of starting chemotherapy. Kaplan-Meier, Cox and Fine-Gray regression (univariate and multivariable) analyses were employed, as appropriate. For the analysis of time-to-SRE, death was considered as a competing event.
RESULTS: Ninety-six out of 693 screened patients were eligible; 89% had a metal stent (the remainder were plastic). The median time of follow-up was 9.6 mo (range 2.2 to 26.4). Forty-one patients (43%) developed a SRE during follow-up [cholangitis (39%), stent obstruction (29%), both (32%)]. There were no significant differences in baseline characteristics between the SRE group and no-SRE groups. Recorded SRE-consequences were: none (37%), chemotherapy delay (24%), discontinuation (17%) and death (22%). The median time-to-SRE was 4.4 mo (95%CI: 3.6-5.5). Patients with severe comorbidities (P < 0.001) and patients with ≥ 2 baseline stents/biliary procedures [HR = 2.3 (95%CI: 1.2-4.44), P = 0.010] had a shorter time-to-SRE on multivariable analysis. Stage was an independent prognostic factor for overall survival (P = 0.029) in the multivariable analysis adjusted for primary tumour site, performance status and development of SRE (SRE group vs no-SRE group).
CONCLUSION: SREs are common and impact on patient’s morbidity. Our results highlight the need for prospective studies exploring the role of prophylactic strategies to prevent/delay SREs.
Core tip: Most patients diagnosed with advanced malignancies of the pancreas or bile ducts present with biliary obstruction; this requires biliary stenting before starting treatment with palliative chemotherapy. The impact of developing stent-related events (SRE) such as cholangitis or stent obstruction (and the potential role of prophylactic treatment in order to reduce the risk of developing SREs) has not been explored in this patient population. Our results have identified that SREs are common and adversely impact on patient’s morbidity (and possibly mortality) and support the need for prospective studies investigating the role of prophylaxis in this population.