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

Biliary SEMS During Neoadjuvant Therapy Study Group

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.)

Original languageEnglish (US)
Pages (from-to)602-612.e4
JournalGastrointestinal endoscopy
Volume90
Issue number4
DOIs
StatePublished - Oct 1 2019

Fingerprint

Neoadjuvant Therapy
Pancreatic Neoplasms
Stents
Metals
Drainage
Gallbladder
Acute Cholecystitis
Pancreaticoduodenectomy
Cholestasis
Jaundice
Clinical Trials

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer : a randomized trial. / Biliary SEMS During Neoadjuvant Therapy Study Group.

In: Gastrointestinal endoscopy, Vol. 90, No. 4, 01.10.2019, p. 602-612.e4.

Research output: Contribution to journalArticle

@article{6f4833b7153e4db1805be1230033dbf4,
title = "Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial",
abstract = "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.)",
author = "{Biliary SEMS During Neoadjuvant Therapy Study Group} and Seo, {Dong Wan} and Stuart Sherman and Dua, {Kulwinder S.} and Adam Slivka and Andre Roy and Guido Costamagna and Jacques Deviere and Joyce Peetermans and Matthew Rousseau and Yousuke Nakai and Hiroyuki Isayama and Richard Kozarek",
year = "2019",
month = "10",
day = "1",
doi = "10.1016/j.gie.2019.06.032",
language = "English (US)",
volume = "90",
pages = "602--612.e4",
journal = "Gastrointestinal Endoscopy",
issn = "0016-5107",
publisher = "Mosby Inc.",
number = "4",

}

TY - JOUR

T1 - Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer

T2 - a randomized trial

AU - Biliary SEMS During Neoadjuvant Therapy Study Group

AU - Seo, Dong Wan

AU - Sherman, Stuart

AU - Dua, Kulwinder S.

AU - Slivka, Adam

AU - Roy, Andre

AU - Costamagna, Guido

AU - Deviere, Jacques

AU - Peetermans, Joyce

AU - Rousseau, Matthew

AU - Nakai, Yousuke

AU - Isayama, Hiroyuki

AU - Kozarek, Richard

PY - 2019/10/1

Y1 - 2019/10/1

N2 - 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.)

AB - 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.)

UR - http://www.scopus.com/inward/record.url?scp=85072018483&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85072018483&partnerID=8YFLogxK

U2 - 10.1016/j.gie.2019.06.032

DO - 10.1016/j.gie.2019.06.032

M3 - Article

C2 - 31276674

AN - SCOPUS:85072018483

VL - 90

SP - 602-612.e4

JO - Gastrointestinal Endoscopy

JF - Gastrointestinal Endoscopy

SN - 0016-5107

IS - 4

ER -