Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial

      Background and Aims

      Preoperative biliary drainage with self-expanding metal stents (SEMSs) brings liver function within an acceptable range in preparation for neoadjuvant therapy (NATx) and provides relief of obstructive symptoms in patients with pancreatic cancer. We compared fully-covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs) for sustained biliary drainage before and during NATx.

      Methods

      Patients with pancreatic cancer and planned NATx who need treatment of jaundice and/or cholestasis before pancreaticoduodenectomy were randomized to FCSEMSs versus UCSEMSs. The primary endpoint was sustained biliary drainage, defined as the absence of reinterventions for biliary obstructive symptoms, and was assessed from SEMS placement until curative intent surgery or at 1 year.

      Results

      The intention-to-treat population included 119 patients (59 FCSEMSs, 60 UCSEMSs). Sustained biliary drainage was equally successful with FCSEMSs and UCSEMSs (72.2% vs 72.9%, noninferiority P = .01). Reasons for FCSEMS and UCSEMS failure differed significantly between the groups and included tumor ingrowth in 0% versus 16.7% (P < .01), and stent migration in 6.8% versus 0% (P = .03), respectively. Serious adverse event rates related to stent placement were not significantly different in both groups (23.7% [14/59] vs 20.0% [12/60], P = .66), as were acute cholecystitis rates when the gallbladder was in situ (9.3% [4/43] vs 4.8% [2/42], P = .68) for FCSEMSs and UCSEMSs, respectively. In our study, independent of stent type, predictors of reinterventions were 4-cm stent length and presence of the gallbladder.

      Conclusion

      FCSEMSs and UCSEMSs provide similar preoperative management of biliary obstruction in patients with pancreatic cancer receiving NATx, but mechanisms of stent dysfunction depend on stent type, stent length, and presence of the gallbladder. (Clinical trial registration number: NCT02238847.)

      Graphical abstract

      Abbreviations:

      AE (adverse event), CIS (curative intent surgery), CSEMS (covered self-expanding metal stent), FCSEMS (fully-covered self-expanding metal stent), FNB (fine-needle biopsy), ITT (intention-to-treat), LFT (liver function test), NATx (neoadjuvant therapy), PP (per protocol), SEMS (self-expanding metal stent), UCSEMS (uncovered self-expanding metal stent)
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      Linked Article

      • Erratum
        Gastrointestinal EndoscopyVol. 90Issue 5
        • Preview
          In the print version of the article “Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial” by Seo et al (Gastrointest Endosc 2019;90:602-12.e4), there was a typographical error in Figure 1. The complete corrected figure appears below.
        • Full-Text
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      • Erratum
        Gastrointestinal EndoscopyVol. 94Issue 4
        • Preview
          In the Gastrointestinal Endoscopy article by Seo et al entitled Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial (Gastrointest Endosc 2019;90:602-12.), the number of patients in the fully covered SEMS (FC SEMS) group who experienced a stent migration was correctly reported as 5 patients, the ratio of patients who experienced FC SEMS migration was correctly reported as 5/59, the P value associated with the comparison of the groups was correctly reported as 0.03, and the 5 migrations were correctly listed in Supplementary Table 1, but the percentage of patients who experienced a FC SEMS migration was incorrectly reported as 6.8% whereas the correct percentage is 8.5%.
        • Full-Text
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