Introduction In pancreatic cancer, preoperative biliary drainage (PBD) increases complications compared with surgery without PBD, demonstrated by a recent randomised controlled trial (RCT). This outcome might be related to the plastic endoprosthesis used. Metal stents may reduce the PBD-related complications risk.
Methods A prospective multicentre cohort study was performed including patients with obstructive jaundice due to pancreatic cancer, scheduled to undergo PBD before surgery. This cohort was added to the earlier RCT (ISRCTN31939699). The RCT protocol was adhered to, except PBD was performed with a fully covered self-expandable metal stent (FCSEMS). This FCSEMS cohort was compared with the RCT’s plastic stent cohort. PBD-related complications were the primary outcome. Three-group comparison of overall complications including early surgery patients was performed.
Results 53 patients underwent PBD with FCSEMS compared with 102 patients treated with plastic stents. Patients’ characteristics did not differ. PBD-related complication rates were 24% in the FCSEMS group vs 46% in the plastic stent group (relative risk of plastic stent use 1.9, 95% CI 1.1 to 3.2, p=0.011). Stent-related complications (occlusion and exchange) were 6% vs 31%. Surgical complications did not differ, 40% vs 47%. Overall complication rates for the FCSEMS, plastic stent and early surgery groups were 51% vs 74% vs 39%.
Conclusions For PBD in pancreatic cancer, FCSEMS yield a better outcome compared with plastic stents. Although early surgery without PBD remains the treatment of choice, FCSEMS should be preferred over plastic stents whenever PBD is indicated.
Trial registration number: Dutch Trial Registry (NTR3142).
- ABDOMINAL SURGERY
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Contributors JAMGT was responsible for the implementation of the study, analysis of data, drafting and revising the manuscript as first author. JEvH, PF, TMvG, EAJR, ORCB and DJG were responsible for the conception of the design, this design was then elaborated and approved after several meetings by all other authors; JAMGT, RT, FJGMK, EvdH, IHJTdH, FPV, IQM, YCAK, DB, MJB, EJS, NAvdG and MGHB. All authors were responsible for conducting the study, including patients and acquisition of data, and interpretation of this data after analysis. After the initial manuscript was drafted, all authors revised the manuscript critically and approved the final version. All authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Competing interests None declared.
Ethics approval The local medical ethics committees of all participating hospitals approved the study design. This study was conducted according to the Declaration of Helsinki.
Provenance and peer review Not commissioned; externally peer reviewed.