Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial

Timothy B. Gardner, Chad C. Spangler, Katerina L. Byanova, Gregory H. Ripple, Matthew J. Rockacy, John Levenick, Kerrington D. Smith, Thomas A. Colacchio, Richard J. Barth, Bassem I. Zaki, Michael J. Tsapakos, Stuart R. Gordon

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background and Aims The optimal type of stent for the palliation of malignant biliary obstruction in patients with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative intent is unknown. We performed a prospective trial comparing 3 types of biliary stents—fully covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and plastic—to determine which best optimized cost-effectiveness and important clinical outcomes. Methods In this prospective randomized trial, consecutive patients with malignant biliary obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical resection, or death after the initiation of neoadjuvant therapy, and the secondary outcomes were total patient costs associated with the stent, including the index ERCP cost, downstream hospitalization cost due to stent occlusion, and the cost associated with procedural adverse event. Results Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic or tumor characteristic differences were noted among the groups. The fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74 and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01). Conclusions In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant biliary obstruction in patients undergoing neoadjuvant therapy with curative intent for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness, although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (Clincial trial registration number: NCT01038713.)

Original languageEnglish (US)
Pages (from-to)460-466
Number of pages7
JournalGastrointestinal Endoscopy
Volume84
Issue number3
DOIs
StatePublished - Sep 1 2016

Fingerprint

Neoadjuvant Therapy
Cost-Benefit Analysis
Stents
Adenocarcinoma
Randomized Controlled Trials
Plastics
Costs and Cost Analysis
Endoscopic Retrograde Cholangiopancreatography
Chemoradiotherapy
Hospitalization
Metals

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Gardner, Timothy B. ; Spangler, Chad C. ; Byanova, Katerina L. ; Ripple, Gregory H. ; Rockacy, Matthew J. ; Levenick, John ; Smith, Kerrington D. ; Colacchio, Thomas A. ; Barth, Richard J. ; Zaki, Bassem I. ; Tsapakos, Michael J. ; Gordon, Stuart R. / Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial. In: Gastrointestinal Endoscopy. 2016 ; Vol. 84, No. 3. pp. 460-466.
@article{9cea1528ee324ffe99f45e9447260ecb,
title = "Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial",
abstract = "Background and Aims The optimal type of stent for the palliation of malignant biliary obstruction in patients with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative intent is unknown. We performed a prospective trial comparing 3 types of biliary stents—fully covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and plastic—to determine which best optimized cost-effectiveness and important clinical outcomes. Methods In this prospective randomized trial, consecutive patients with malignant biliary obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical resection, or death after the initiation of neoadjuvant therapy, and the secondary outcomes were total patient costs associated with the stent, including the index ERCP cost, downstream hospitalization cost due to stent occlusion, and the cost associated with procedural adverse event. Results Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic or tumor characteristic differences were noted among the groups. The fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74 and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01). Conclusions In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant biliary obstruction in patients undergoing neoadjuvant therapy with curative intent for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness, although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (Clincial trial registration number: NCT01038713.)",
author = "Gardner, {Timothy B.} and Spangler, {Chad C.} and Byanova, {Katerina L.} and Ripple, {Gregory H.} and Rockacy, {Matthew J.} and John Levenick and Smith, {Kerrington D.} and Colacchio, {Thomas A.} and Barth, {Richard J.} and Zaki, {Bassem I.} and Tsapakos, {Michael J.} and Gordon, {Stuart R.}",
year = "2016",
month = "9",
day = "1",
doi = "10.1016/j.gie.2016.02.047",
language = "English (US)",
volume = "84",
pages = "460--466",
journal = "Gastrointestinal Endoscopy",
issn = "0016-5107",
publisher = "Mosby Inc.",
number = "3",

}

Gardner, TB, Spangler, CC, Byanova, KL, Ripple, GH, Rockacy, MJ, Levenick, J, Smith, KD, Colacchio, TA, Barth, RJ, Zaki, BI, Tsapakos, MJ & Gordon, SR 2016, 'Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial', Gastrointestinal Endoscopy, vol. 84, no. 3, pp. 460-466. https://doi.org/10.1016/j.gie.2016.02.047

Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial. / Gardner, Timothy B.; Spangler, Chad C.; Byanova, Katerina L.; Ripple, Gregory H.; Rockacy, Matthew J.; Levenick, John; Smith, Kerrington D.; Colacchio, Thomas A.; Barth, Richard J.; Zaki, Bassem I.; Tsapakos, Michael J.; Gordon, Stuart R.

In: Gastrointestinal Endoscopy, Vol. 84, No. 3, 01.09.2016, p. 460-466.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial

AU - Gardner, Timothy B.

AU - Spangler, Chad C.

AU - Byanova, Katerina L.

AU - Ripple, Gregory H.

AU - Rockacy, Matthew J.

AU - Levenick, John

AU - Smith, Kerrington D.

AU - Colacchio, Thomas A.

AU - Barth, Richard J.

AU - Zaki, Bassem I.

AU - Tsapakos, Michael J.

AU - Gordon, Stuart R.

PY - 2016/9/1

Y1 - 2016/9/1

N2 - Background and Aims The optimal type of stent for the palliation of malignant biliary obstruction in patients with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative intent is unknown. We performed a prospective trial comparing 3 types of biliary stents—fully covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and plastic—to determine which best optimized cost-effectiveness and important clinical outcomes. Methods In this prospective randomized trial, consecutive patients with malignant biliary obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical resection, or death after the initiation of neoadjuvant therapy, and the secondary outcomes were total patient costs associated with the stent, including the index ERCP cost, downstream hospitalization cost due to stent occlusion, and the cost associated with procedural adverse event. Results Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic or tumor characteristic differences were noted among the groups. The fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74 and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01). Conclusions In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant biliary obstruction in patients undergoing neoadjuvant therapy with curative intent for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness, although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (Clincial trial registration number: NCT01038713.)

AB - Background and Aims The optimal type of stent for the palliation of malignant biliary obstruction in patients with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative intent is unknown. We performed a prospective trial comparing 3 types of biliary stents—fully covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and plastic—to determine which best optimized cost-effectiveness and important clinical outcomes. Methods In this prospective randomized trial, consecutive patients with malignant biliary obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical resection, or death after the initiation of neoadjuvant therapy, and the secondary outcomes were total patient costs associated with the stent, including the index ERCP cost, downstream hospitalization cost due to stent occlusion, and the cost associated with procedural adverse event. Results Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic or tumor characteristic differences were noted among the groups. The fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74 and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01). Conclusions In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant biliary obstruction in patients undergoing neoadjuvant therapy with curative intent for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness, although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (Clincial trial registration number: NCT01038713.)

UR - http://www.scopus.com/inward/record.url?scp=84975494939&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84975494939&partnerID=8YFLogxK

U2 - 10.1016/j.gie.2016.02.047

DO - 10.1016/j.gie.2016.02.047

M3 - Article

VL - 84

SP - 460

EP - 466

JO - Gastrointestinal Endoscopy

JF - Gastrointestinal Endoscopy

SN - 0016-5107

IS - 3

ER -