Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-12-06
Brief Title:
Flare Type Self-expandable Metal Stents SEMS vs Plastic Stent for the Treatment of Difficult Common Bile Duct Stone
Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Organization:
Azienda Ospedaliero-Universitaria di Modena
Study Overview
Official Title:
Flare Type Self-expandable Metal Stents SEMS vs Plastic Stent for the Treatment of Difficult Common Bile Duct Stone a Randomized Post-marketing Multicenter Italian Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEMASTI
Brief Summary:
Migration of stones from the gallbladder to the common bile duct CBD facilitated by gallbladder contractions can be listed as a complication of gallstones disease In the case of common bile duct stone CBDs migration an endoscopic cholangiopancreatography ERCP should be offered for both symptomatic and asymptomatic patients fit for the procedure An ERCP with an adequate endoscopic sphincterotomy obtains a complete biliary clearance in about 80-90 of the patients5 Whilst most cases are successfully treated with such first-line approaches about 10-15 need alternative andor adjunctive techniques to achieve bile duct clearance These conditions are generally defined as difficult bile duct stones a broad category of cases that encompasses very different scenarios In the case of irretrievable CBDs the European Society of Gastrointestinal Endoscopy ESGE recommends the endoscopic placement of a temporary biliary plastic stent to warrant biliary drainage Since their introduction fully covered self-expanding metal stents FCSEMS have rapidly been adopted for the treatment of benign biliary conditions such as strictures leaks or bleeding In a recent retrospective study it has been shown that FCSEMS are useful in the approach of difficult lithiasis of CBD with no significant adverse events associated Moreover a promising FC-SEMS with a particular prosthesis design flare type - Niti-S S-Type Taewoong could be even more useful since it reduces the frequent complication of fully covered stents which is the migration of the prosthesis However prospective data on the effectiveness and on the adverse events rate on the use of SEMS for incomplete stone CBDs clearance are still lacking Therefore the investigators aim to estimate the incidence of adverse events complete biliary clearance and migration rate after 3-6 month from ERCP index stent positioning comparing plastic stents vs FC-SEMS Niti-S flare type - Taewoong
Detailed Description:
BACKGROUND
The presence of gallstones is a very common condition worldwide especially in developed countries where it is estimated to affect 10-15 of the adult population and accounts for a great part of total gastrointestinal-related healthcare expenditures1 Fortunately only 10-25 of gallstones became symptomatic in their lifetime with an annual incidence of 2-3 per year 2 3 Moreover the worldwide increase in obesity and in the prevalence of non-alcoholic fatty liver disease NAFLD which represents a risk factor for gallstones could contribute to the rising gallstone disease prevalence4 Migration of stones from the gallbladder to the common bile duct CBD facilitated by gallbladder contractions can be listed as a complication of gallstones disease In the case of common bile duct stone CBDs migration an endoscopic cholangiopancreatography ERCP should be offered for both symptomatic and asymptomatic patients fit for the procedure1 3 An ERCP with an adequate endoscopic sphincterotomy obtains a complete biliary clearance in about 80-90 of the patients5 Whilst most cases are successfully treated with such first-line approaches about 10-15 need alternative andor adjunctive techniques to achieve bile duct clearance1 5 These conditions are generally defined as difficult bile duct stones a broad category of cases that encompasses very different scenarios including large or multiple stones peculiar stone shapes eg barrel-shaped stones located above a stricture or impacted intrahepatic stones altered distal bile duct oblique narrowed sigmoid-shaped In the case of irretrievable CBDs the European Society of Gastrointestinal Endoscopy ESGE recommends the endoscopic placement of a temporary biliary plastic stent to warrant biliary drainage1 5 6
Numerous non-randomized studies both prospective and retrospective showed that an indwelling plastic stent may reduce the number and the size of CBDs7-9 although the mechanism by which the endoprosthesis contributes to the clearance of CBD is unclear Probably the continuous friction between the CBDs and the stent contributes to producing mechanical stress that facilitates the disruption of the stones10 Available data showed that the biliary plastic stent had a success rate ranging from 44 to 96 for stone removal after the previous ERCP11-14 Since their introduction fully covered self-expanding metal stents FCSEMS have rapidly been adopted for the treatment of benign biliary conditions such as strictures leaks or bleeding In a recent retrospective study it has been shown that FCSEMS are useful in the approach of difficult lithiasis of CBD with no significant adverse events associated9 However comparative prospective data between plastic and metal stents are still lacking Theoretically FC-SEMS could be more effective compared to the plastic stent in producing stress forces that facilitate the stone disintegration but the quality of this evidence is still very low due to lack of data
Moreover a promising FC-SEMS with a particular prosthesis design flare type - Niti-S S-Type Taewoong could be even more useful since it reduces the frequent complication of fully covered stents which is the migration of the prosthesis15-17 However the majority of the data concerning SEMS migration rate are available for the treatment of benign biliary stricture understandably with a low rate of both distal and proximal migration17 However prospective data on the effectiveness and on the adverse events rate on the use of SEMS for incomplete stone CBDs clearance are still lacking A definitive biliary stenting is not recommended by ESGE guidelines but it is warranted to completely remove the CBD stones during the second ERCP if possible
AIM The investigators aim to estimate the incidence of adverse events complete biliary clearance and migration rate after 3-6 month from ERCP index stent positioning comparing plastic stents vs FC-SEMS Niti-S flare type - Taewoong
The presence of gallstones is a very common condition worldwide especially in developed countries where it is estimated to affect 10-15 of the adult population and accounts for a great part of total gastrointestinal-related healthcare expenditures1 Fortunately only 10-25 of gallstones became symptomatic in their lifetime with an annual incidence of 2-3 per year 2 3 Moreover the worldwide increase in obesity and in the prevalence of non-alcoholic fatty liver disease NAFLD which represents a risk factor for gallstones could contribute to the rising gallstone disease prevalence4 Migration of stones from the gallbladder to the common bile duct CBD facilitated by gallbladder contractions can be listed as a complication of gallstones disease In the case of common bile duct stone CBDs migration an endoscopic cholangiopancreatography ERCP should be offered for both symptomatic and asymptomatic patients fit for the procedure1 3 An ERCP with an adequate endoscopic sphincterotomy obtains a complete biliary clearance in about 80-90 of the patients5 Whilst most cases are successfully treated with such first-line approaches about 10-15 need alternative andor adjunctive techniques to achieve bile duct clearance1 5 These conditions are generally defined as difficult bile duct stones a broad category of cases that encompasses very different scenarios including large or multiple stones peculiar stone shapes eg barrel-shaped stones located above a stricture or impacted intrahepatic stones altered distal bile duct oblique narrowed sigmoid-shaped In the case of irretrievable CBDs the European Society of Gastrointestinal Endoscopy ESGE recommends the endoscopic placement of a temporary biliary plastic stent to warrant biliary drainage1 5 6
Numerous non-randomized studies both prospective and retrospective showed that an indwelling plastic stent may reduce the number and the size of CBDs7-9 although the mechanism by which the endoprosthesis contributes to the clearance of CBD is unclear Probably the continuous friction between the CBDs and the stent contributes to producing mechanical stress that facilitates the disruption of the stones10 Available data showed that the biliary plastic stent had a success rate ranging from 44 to 96 for stone removal after the previous ERCP11-14 Since their introduction fully covered self-expanding metal stents FCSEMS have rapidly been adopted for the treatment of benign biliary conditions such as strictures leaks or bleeding In a recent retrospective study it has been shown that FCSEMS are useful in the approach of difficult lithiasis of CBD with no significant adverse events associated9 However comparative prospective data between plastic and metal stents are still lacking Theoretically FC-SEMS could be more effective compared to the plastic stent in producing stress forces that facilitate the stone disintegration but the quality of this evidence is still very low due to lack of data
Moreover a promising FC-SEMS with a particular prosthesis design flare type - Niti-S S-Type Taewoong could be even more useful since it reduces the frequent complication of fully covered stents which is the migration of the prosthesis15-17 However the majority of the data concerning SEMS migration rate are available for the treatment of benign biliary stricture understandably with a low rate of both distal and proximal migration17 However prospective data on the effectiveness and on the adverse events rate on the use of SEMS for incomplete stone CBDs clearance are still lacking A definitive biliary stenting is not recommended by ESGE guidelines but it is warranted to completely remove the CBD stones during the second ERCP if possible
AIM The investigators aim to estimate the incidence of adverse events complete biliary clearance and migration rate after 3-6 month from ERCP index stent positioning comparing plastic stents vs FC-SEMS Niti-S flare type - Taewoong
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None