Original article
605
Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis
Authors
Carola Haapamäki1, Leena Kylänpää1, Marianne Udd1, Outi Lindström1, Juha Grönroos2, Arto Saarela3, Harri Mustonen1, Jorma Halttunen1
Institutions
1
Department of Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland Department of Digestive Surgery, Turku University Hospital, Turku, Finland 3 Department of Gastrointestinal Surgery, Oulu University Hospital, Oulu, Finland
submitted 11. June 2014 accepted after revision 27. November 2014
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1391331 Published online: 15.1.2015 Endoscopy 2015; 47: 605–610 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Jorma Halttunen, MD, PhD Meilahti Hospital P.O. Box 340 00029 HUS Finland Fax: +358–9471–74688 [email protected]
Background and study aims: The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis. Patients and methods: This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal.
Results: Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 – 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % – 97 %) in the plastic stent group and 92 % (95 %CI 70 % – 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000). Conclusion: A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis. Study registered at ClinicalTrials.gov (NCT01085747).
Introduction
of cases [5, 6]. The use of uncovered, self-expandable metallic stents (SEMS) in benign biliary strictures (BBS) is not recommended because of removal problems caused by embedding [7, 8]. If endoscopic treatment is selected, the ESGE recommends temporary placement of multiple plastic stents [3]. A removable covered, self-expandable metallic stent (cSEMS) is a particularly intriguing option for treatment of BBS, as a 10-mm cSEMS corresponds to a CBD diameter achieved by six or seven 10-Fr plastic stents [9 – 14]. The aim of the present prospective randomized study was to compare the safety and feasibility of cSEMS with multiple plastic stents in the treatment of biliary stricture caused by chronic pancreatitis with or without an acute component.
!
Scan this QR-Code to watch the video comment.
A common bile duct (CBD) stricture occurs as a complication of chronic pancreatitis in 3 % – 23 % of cases. The clinical presentation ranges from incidental findings to severe jaundice and cholangitis [1]. A small proportion of patients may develop secondary biliary cirrhosis [2]. The European Society of Gastrointestinal Endoscopy (ESGE) recommends treating chronic pancreatitis-related CBD strictures in cases of symptoms, secondary biliary cirrhosis, bile duct stones, progression of biliary stricture or when unicteric cholestasis (a serum alkaline phosphatase [AFOS] level greater than twice the upper limit) persists for more than 1 month [3]. When a CBD stricture caused by chronic pancreatitis has been treated endoscopically using a single biliary plastic stent, the long-term success has been disappointing [4]. Stenting with multiple plastic stents has led to success in 60 % – 92 %
Haapamäki Carola et al. Multiple plastic vs. covered metallic stents for biliary stricture in chronic pancreatitis … Endoscopy 2015; 47: 605–610
Downloaded by: National University of Singapore. Copyrighted material.
2
Original article
ERCP I
Sphincterotomy and one 10 Fr NEPS (n = 60)
ERCP II, randomization 1–3 months later
Dilation + stent exchange to 3 10 Fr NEPS (n = 30)
Dilation + stent exchange to 10 mm cSEMS (n = 30; 20 Hanaro®, 6 Wallflex®, 4 Wallstent®) 1 dropout1
ERCP III, 3 months later
Dilation + deployment of up to 3 additional 10 Fr NEPS when possible; exchange of occluded stents (n = 30)
cSEMS check and dilation or stent exchange if needed (n = 29) 1 dropout1
ERCP IV, 3 months later
Scheduled follow-up 6 months from stent removal
Scheduled follow-up 2 years from stent removal
2 dropouts2, 2 recurrent strictures, 3 no show for this follow-up 2 previous no shows showed up, 1 recurrent stricture, 2 have < 2 years from stent removal
Contacting the ERCP unit on demand only, no scheduled follow-ups
Removal of stents (n = 30)
Removal of stent (n = 28) 2 dropouts3, 4 no show for this follow-up
Total recurrent strictures = 2
Total recurrent strictures = 0
Showed up for this follow-up = 23
Showed up for this follow-up = 22
Total recurrent strictures = 3
Total recurrent strictures = 2
Showed up for this follow-up = 22
Showed up for this follow-up = 20
Total analyzed = 30
Total analyzed = 28
Excluded from analysis = 0
Excluded from analysis = 21
Previous no shows showed up, 2 recurrent strictures, 4 have
605
Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis
Authors
Carola Haapamäki1, Leena Kylänpää1, Marianne Udd1, Outi Lindström1, Juha Grönroos2, Arto Saarela3, Harri Mustonen1, Jorma Halttunen1
Institutions
1
Department of Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland Department of Digestive Surgery, Turku University Hospital, Turku, Finland 3 Department of Gastrointestinal Surgery, Oulu University Hospital, Oulu, Finland
submitted 11. June 2014 accepted after revision 27. November 2014
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1391331 Published online: 15.1.2015 Endoscopy 2015; 47: 605–610 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Jorma Halttunen, MD, PhD Meilahti Hospital P.O. Box 340 00029 HUS Finland Fax: +358–9471–74688 [email protected]
Background and study aims: The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis. Patients and methods: This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal.
Results: Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 – 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % – 97 %) in the plastic stent group and 92 % (95 %CI 70 % – 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000). Conclusion: A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis. Study registered at ClinicalTrials.gov (NCT01085747).
Introduction
of cases [5, 6]. The use of uncovered, self-expandable metallic stents (SEMS) in benign biliary strictures (BBS) is not recommended because of removal problems caused by embedding [7, 8]. If endoscopic treatment is selected, the ESGE recommends temporary placement of multiple plastic stents [3]. A removable covered, self-expandable metallic stent (cSEMS) is a particularly intriguing option for treatment of BBS, as a 10-mm cSEMS corresponds to a CBD diameter achieved by six or seven 10-Fr plastic stents [9 – 14]. The aim of the present prospective randomized study was to compare the safety and feasibility of cSEMS with multiple plastic stents in the treatment of biliary stricture caused by chronic pancreatitis with or without an acute component.
!
Scan this QR-Code to watch the video comment.
A common bile duct (CBD) stricture occurs as a complication of chronic pancreatitis in 3 % – 23 % of cases. The clinical presentation ranges from incidental findings to severe jaundice and cholangitis [1]. A small proportion of patients may develop secondary biliary cirrhosis [2]. The European Society of Gastrointestinal Endoscopy (ESGE) recommends treating chronic pancreatitis-related CBD strictures in cases of symptoms, secondary biliary cirrhosis, bile duct stones, progression of biliary stricture or when unicteric cholestasis (a serum alkaline phosphatase [AFOS] level greater than twice the upper limit) persists for more than 1 month [3]. When a CBD stricture caused by chronic pancreatitis has been treated endoscopically using a single biliary plastic stent, the long-term success has been disappointing [4]. Stenting with multiple plastic stents has led to success in 60 % – 92 %
Haapamäki Carola et al. Multiple plastic vs. covered metallic stents for biliary stricture in chronic pancreatitis … Endoscopy 2015; 47: 605–610
Downloaded by: National University of Singapore. Copyrighted material.
2
Original article
ERCP I
Sphincterotomy and one 10 Fr NEPS (n = 60)
ERCP II, randomization 1–3 months later
Dilation + stent exchange to 3 10 Fr NEPS (n = 30)
Dilation + stent exchange to 10 mm cSEMS (n = 30; 20 Hanaro®, 6 Wallflex®, 4 Wallstent®) 1 dropout1
ERCP III, 3 months later
Dilation + deployment of up to 3 additional 10 Fr NEPS when possible; exchange of occluded stents (n = 30)
cSEMS check and dilation or stent exchange if needed (n = 29) 1 dropout1
ERCP IV, 3 months later
Scheduled follow-up 6 months from stent removal
Scheduled follow-up 2 years from stent removal
2 dropouts2, 2 recurrent strictures, 3 no show for this follow-up 2 previous no shows showed up, 1 recurrent stricture, 2 have < 2 years from stent removal
Contacting the ERCP unit on demand only, no scheduled follow-ups
Removal of stents (n = 30)
Removal of stent (n = 28) 2 dropouts3, 4 no show for this follow-up
Total recurrent strictures = 2
Total recurrent strictures = 0
Showed up for this follow-up = 23
Showed up for this follow-up = 22
Total recurrent strictures = 3
Total recurrent strictures = 2
Showed up for this follow-up = 22
Showed up for this follow-up = 20
Total analyzed = 30
Total analyzed = 28
Excluded from analysis = 0
Excluded from analysis = 21
Previous no shows showed up, 2 recurrent strictures, 4 have
