No Benefit of Endoscopic Sphincterotomy Before Biliary Placement of Self-Expandable Metal Stents for Unresectable Pancreatic Cancer

Hayashi, Tsuyoshi; Kawakami, Hiroshi; Osanai, Manabu; Ishiwatari, Hirotoshi; Naruse, Hirohito; Hisai, Hiroyuki; Yanagawa, Nobuyuki; Kaneto, Hiroyuki; Koizumi, Kazuya; Sakurai, Takahisa; Sonoda, Tomoko

doi:10.1016/j.cgh.2015.01.008

Cited by 58 publications

(43 citation statements)

References 24 publications

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“…After the third episode of PEP, sphincterotomies were routinely performed in all patients receiving SEMSs, and only 2 further episodes of PEP occurred. 15 This suggests a learning curve which, had the study been started after the initiation of routine sphincterotomy, potentially would have resulted in an even more robust clinical benefit to SEMS.…”

Section: Discussionmentioning

confidence: 99%

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

Gardner

Spangler

Byanova

et al. 2016

Gastrointestinal Endoscopy

116

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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 not known. We performed a prospective trial comparing 3 types of biliary stents—fully covered self-expandable metal stents (fcSEMSs), uncovered self-expandable metal stents (uSEMSs), and plastic stents—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 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 A total of 54 patients were randomized and reached the primary endpoint; 16 patients in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic group. No baseline demographic or tumor characteristic differences were noted between groups. fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (219 vs. 88 and 75 days, p<0.01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701, p <0.01), they resulted in higher procedural adverse event costs per patient (uSEMS $5521 and fcSEMS=$12,701 vs plastic = $0, p<0.01). Conversely, plastic stents resulted in a $11,458 hospitalization cost per patient due to stent occlusion, compared with $2301 for uSEMSs and $0 for fcSEMSs (p<0.01). The total cost of the index ERCP, procedural adverse events associated with the index ERCP and adverse events from stent occlusion were similar between stent types (fcSEMSs = $41,112; uSEMSs = $41,475; and plastic = $39,955; p=1.00). There was no difference between groups in terms of number of days hospitalized for index ERCP adverse event and/or stent occlusion, although fcSEMSs resulted in fewer total days (3) of neoadjuvant treatment delay than uSEMSs (39) or plastic stents (79) (p<0.01). 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 fcSEMS resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (ClincialTrials.gov, number NCT01038713)

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Section: Discussionmentioning

confidence: 99%

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

Gardner

Spangler

Byanova

et al. 2016

Gastrointestinal Endoscopy

116

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“…The overall rate of early post-ERCP complications after SEMS placement with limited ES was 3.7%, including a 2.9% incidence of PEP, and 0.8% of mild bleeding. These rates of complications are relatively low compared to the complication rates of approximately 10% and an overall mortality of 0.42% in published data[2,13-17]. …”

Section: Discussionmentioning

confidence: 73%

“…However, the role of routine ES before stenting is still controversial and no clear guidelines exist to govern its use. Additionally, ES is also an independent risk factor for complications such as pancreatitis, bleeding, and perforation, with a reported complication rate of approximately 10% and an overall direct or indirect procedure-related mortality of 0.42%, even when performed by experienced endoscopists[2,13-17]. However, an accurate assessment of the incidence of complications based on the extent of ES is difficult to make owing to the lack of such data in previous studies.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction

Nam

Kang

Kim

et al. 2017

WJG

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AIMTo evaluate the safety and efficacy of limited endoscopic sphincterotomy (ES) before placement of selfexpandable metal stent (SEMS). METHODSThis was a retrospective analysis of 244 consecutive patients with unresectable malignant biliary obstruction, who underwent placement of SEMSs following limited ES from December 2008 to February 2015. The diagnosis of malignant biliary obstruction and assessment of patient eligibility for the study was established by a combination of clinical findings, laboratory investigations, imaging and pathological results. All patients were monitored in the hospital for at least 24 h following endoscopic retrograde cholangio pancreatography (ERCP). The incidence of immediate or early post-ERCP complications such as post-ERCP pancreatitis (PEP) and bleeding related to limited ES were considered as primary outcomes. Also, characteristics and complications according to the cancer type were classified. RESULTSAmong the 244 patients included, the underlying diagnosis was cholangiocarcinoma in 118 patients, Core tip: The role of routine endoscopic sphincterotomy (ES) is still controversial in biliary stenting and there is a lack of systematic study for the extent of ES and its correlation with the incidence of complications. We retrospectively evaluated the safety and efficacy of limited ES before self-expandable metal stent insertion. We have proved in this study that limited ES doesn't increase the risk of post-procedure complications such as post-endoscopic retrograde cholangio pancreatography pancreatitis and bleeding. Also, it is advantageous in facilitating the more complex stenting procedures. Therefore, limited ES can be a safe, feasible, and effective therapeutic strategy in the placement of self-expandable metal stent.Nam HS, Kang DH, Kim HW, Choi CW, Park SB, Kim SJ, Ryu DG. Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction.

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“…Importantly, stent-related AEs were also significantly lower in the SEMS group (6% vs 30%), primarily due to a reduction in cholangitis (0% vs 26%). It is also worth noting that post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis occurred in 18% of SEMS patients (one severe case) compared with 7% in the plastic stent group, a finding not shown previously and which does not appear to be influenced by endoscopic sphincterotomy 7. Surgical AEs were comparable.…”

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confidence: 73%

Relief of obstructive jaundice from pancreatic cancer: the end of the plastic stent era?

Baron

Grimm

2015

Gut

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No Benefit of Endoscopic Sphincterotomy Before Biliary Placement of Self-Expandable Metal Stents for Unresectable Pancreatic Cancer

Cited by 58 publications

References 24 publications

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

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

Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction

Relief of obstructive jaundice from pancreatic cancer: the end of the plastic stent era?

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