Biliary StonesTEMASTINCT06170632
Flare Type Self-expandable Metal Stents (SEMS) vs Plastic Stent for the Treatment of Difficult Common Bile Duct Stone
A study testing Biliary drainage in people with Biliary Stones and Bile Duct Diseases, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stones, Bile Duct Diseases, Bile Duct Obstruction
- What is being tested?
- Biliary drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 year-old with difficult common bile duct stones as defined by the current ESGE guidelines
- Patients with irretrievable biliary stone and incomplete biliary drainage
Who cannot join
- Biliary malignant obstruction
- Other type of biliary benign or malignant stenosis
Trial locations and contacts
1 site in 1 country.
About this study
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
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 patients[5]. Whilst most cases are successfully treated with such first-line approaches, about 10-15% need alternative and/or 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).
Read the 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 expenditures[1]. 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 prevalence[4]. 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[1, 3]. An ERCP with an adequate endoscopic sphincterotomy obtains a complete biliary clearance in about 80-90% of the patients[5]. Whilst most cases are successfully treated with such first-line approaches, about 10-15% need alternative and/or adjunctive techniques to achieve bile duct clearance[1, 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 (e.g., 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 drainage[1, 5, 6].
Numerous non-randomized studies, both prospective and retrospective, showed that an indwelling plastic stent may reduce the number and the size of CBDs[7-9], 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 stones[10]. Available data showed that the biliary plastic stent had a success rate ranging from 44 to 96% for stone removal after the previous ERCP[11-14]. 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 associated[9]. 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 prosthesis[15-17]. 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 migration[17]. 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).
- Conditions
- Biliary Stones, Bile Duct Diseases, Bile Duct Obstruction
- Being tested
- Biliary drainage
- Keywords
- Common bile duct lithiasis, Difficult lithiasis
- Medical subject headings
- Cholecystolithiasis, Bile Duct Diseases, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary drainageDevice
Biliary drainage with FC-SEMS Niti-S FLARE TYPE
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Intervention group (IG): Patients with flare type SEMS placement Receives: Device: Biliary drainage |
| Control group (CG) | Active comparator | Control group (CG): Patients with plastic stent placement Receives: Device: Biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SILVIA COCCA, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170632
- Sponsor's protocol ID
- 12.2023
- Acronym
- TEMASTI
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Troncone E, Mossa M, De Vico P, Monteleone G, Del Vecchio Blanco G. Difficult Biliary Stones: A Comprehensive Review of New and Old Lithotripsy Techniques. Medicina (Mex). 2022;58:120. 2. Everhart JE, Khare M, Hill M, Maurer KR. Prevalence and ethnic differences in gallbladder disease in the United States. Gastroenterology. 1999;117:632-9. 3. Shabanzadeh DM. Incidence of gallstone disease and complications. Curr Opin Gastroenterol. 2018;34:81-9. 4. Gu S, Hu S, Wang S, Qi C, Shi C, Fan G. Bidirectional association between NAFLD and gallstone disease: a systematic review and meta-analysis of observational studies. Expert Rev Gastroenterol Hepatol. 2023;17:283-93. 5. Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, et al. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019;51:472-91. 6. Dong S, Singh T, Zhao Q, Li J, Wang H. Sphincterotomy plus balloon dilation versus sphincterotomy alone for choledocholithiasis: a meta-analysis. 2019;51:763-71. 7. Katsinelos P, Kountouras J, Paroutoglou G, Chatzimavroudis G, Zavos C. Combination of endoprostheses and oral ursodeoxycholic acid or placebo in the treatment of difficult to extract common bile duct stones. Dig Liver Dis Off J Ital Soc Gastroenterol Ital Assoc Study Liver. 2008;40:453-9. 8. Lee TH, Han J-H, Kim HJ, Park SM, Park S-H, Kim S-J. Is the addition of choleretic agents in multiple double-pigtail biliary stents effective for difficult common bile duct stones in elderly patients? A prospective, multicenter study. Gastrointest Endosc. 2011;74:96-102. 9. Grande G, Pigò F, Avallone L, Bertani H, Mangiafico S, Russo S, et al. Is the use of fully covered metal stents effective in the treatment of difficult lithiasis of the common bile duct? Surg Endosc. 2022;36:5684-91. 10. Horiuchi A, Nakayama Y, Kajiyama M, Kato N, Kamijima T, Graham DY, et al. Biliary stenting in the management of large or multiple common bile duct stones. Gastrointest Endosc. 2010;71:1200-1203.e2. 11. Yang J, Peng J, Chen W. Endoscopic biliary stenting for irretrievable common bile duct stones: Indications, advantages, disadvantages, and follow-up results. Surg J R Coll Surg Edinb Irel. 2012;10:211-7. 12. Kochlef A, Gargouri D, Kilani A, Ouakaa A, Elloumi H, Kharrat J, et al. Retained common bile duct stones after endoscopic sphincterotomy: temporary and longterm treatment with biliary stenting. Tunis Med. 2011;89:342-6. 13. Jain SK, Stein R, Bhuva M, Goldberg MJ. Pigtail stents: an alternative in the treatment of difficult bile duct stones. Gastrointest Endosc. 2000;52:490-3. 14. Maxton DG, Tweedle DE, Martin DF. Retained common bile duct stones after endoscopic sphincterotomy: temporary and longterm treatment with biliary stenting. Gut. 1995;36:446-9. 15. Park DH, Lee SS, Lee TH, Ryu CH, Kim HJ, Seo D-W, et al. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study (with videos). Gastrointest Endosc. 2011;73:64-70. 16. Koksal AS, Eminler AT, Parlak E. Fully Covered Metal Stents Safely Facilitate Extraction of Difficult Bile Duct Stones. Surg Laparosc Endosc Percutan Tech. 2023;33:152-61. 17. Zheng X, Wu J, Sun B, Wu Y-C, Bo Z-Y, Wan W, et al. Clinical outcome of endoscopic covered metal stenting for resolution of benign biliary stricture: Systematic review and meta-analysis. Dig Endosc Off J Jpn Gastroenterol Endosc Soc. 2017;29:198-210. 18. Jang DK, Lee SH, Ahn DW, Paik WH, Lee JM, Lee JK, et al. Correction: Factors associated with complete clearance of difficult common bile duct stones after temporary biliary stenting followed by a second ERCP: a multicenter, retrospective, cohort study. Endoscopy. 2020;52:C4. 19. Jang DK, Lee SH, Ahn DW, Paik WH, Lee JM, Lee JK, et al. Factors associated with complete clearance of difficult common bile duct stones after temporary biliary stenting followed by a second ERCP: a multicenter, retrospective, cohort study. Endoscopy. 2020;52:462-8. 20. Hartery K, Lee CS, Doherty GA, Murray FE, Cullen G, Patchett SE, et al. Covered self-expanding metal stents for the management of common bile duct stones. Gastrointest Endosc. 2017;85:181-6.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06170632
- Acronym / sponsor ID
- TEMASTI / 12.2023
- Conditions
- Biliary Stones, Bile Duct Diseases, Bile Duct Obstruction
- Keywords
- Common bile duct lithiasis, Difficult lithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patients[5]. Whilst most cases are successfully treated with such first-line approaches, about 10-15% need alternative and/or 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 expenditures[1]. 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 prevalence[4]. 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[1, 3]. An ERCP with an adequate endoscopic sphincterotomy obtains a complete biliary clearance in about 80-90% of the patients[5]. Whilst most cases are successfully treated with such first-line approaches, about 10-15% need alternative and/or adjunctive techniques to achieve bile duct clearance[1, 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 (e.g., 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 drainage[1, 5, 6].
Numerous non-randomized studies, both prospective and retrospective, showed that an indwelling plastic stent may reduce the number and the size of CBDs[7-9], 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 stones[10]. Available data showed that the biliary plastic stent had a success rate ranging from 44 to 96% for stone removal after the previous ERCP[11-14]. 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 associated[9]. 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 prosthesis[15-17]. 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 migration[17]. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Device: Biliary drainageIntervention group (IG): Patients with flare type SEMS placement |
| Control group (CG) | Active comparator | Device: Biliary drainageControl group (CG): Patients with plastic stent placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 year-old with difficult common bile duct stones as defined by the current ESGE guidelines
- Patients with irretrievable biliary stone and incomplete biliary drainage
Key exclusion criteria (2 listed)
- Biliary malignant obstruction
- Other type of biliary benign or malignant stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biliary drainageBiliary drainage with FC-SEMS Niti-S FLARE TYPE | Device | Control group (CG), Intervention group |
Primary outcome
Incidence of adverse events
Time frame: 3 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Results publication1. Troncone E, Mossa M, De Vico P, Monteleone G, Del Vecchio Blanco G. Difficult Biliary Stones: A Comprehensive Review of New and Old Lithotripsy Techniques. Medicina (Mex). 2022;58:120. 2. Everhart JE, Khare M, Hill M, Maurer KR. Prevalence and ethnic differences in gallbladder disease in the United States. Gastroenterology. 1999;117:632-9. 3. Shabanzadeh DM. Incidence of gallstone disease and complications. Curr Opin Gastroenterol. 2018;34:81-9. 4. Gu S, Hu S, Wang S, Qi C, Shi C, Fan G. Bidirectional association between NAFLD and gallstone disease: a systematic review and meta-analysis of observational studies. Expert Rev Gastroenterol Hepatol. 2023;17:283-93. 5. Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, et al. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019;51:472-91. 6. Dong S, Singh T, Zhao Q, Li J, Wang H. Sphincterotomy plus balloon dilation versus sphincterotomy alone for choledocholithiasis: a meta-analysis. 2019;51:763-71. 7. Katsinelos P, Kountouras J, Paroutoglou G, Chatzimavroudis G, Zavos C. Combination of endoprostheses and oral ursodeoxycholic acid or placebo in the treatment of difficult to extract common bile duct stones. Dig Liver Dis Off J Ital Soc Gastroenterol Ital Assoc Study Liver. 2008;40:453-9. 8. Lee TH, Han J-H, Kim HJ, Park SM, Park S-H, Kim S-J. Is the addition of choleretic agents in multiple double-pigtail biliary stents effective for difficult common bile duct stones in elderly patients? A prospective, multicenter study. Gastrointest Endosc. 2011;74:96-102. 9. Grande G, Pigò F, Avallone L, Bertani H, Mangiafico S, Russo S, et al. Is the use of fully covered metal stents effective in the treatment of difficult lithiasis of the common bile duct? Surg Endosc. 2022;36:5684-91. 10. Horiuchi A, Nakayama Y, Kajiyama M, Kato N, Kamijima T, Graham DY, et al. Biliary stenting in the management of large or multiple common bile duct stones. Gastrointest Endosc. 2010;71:1200-1203.e2. 11. Yang J, Peng J, Chen W. Endoscopic biliary stenting for irretrievable common bile duct stones: Indications, advantages, disadvantages, and follow-up results. Surg J R Coll Surg Edinb Irel. 2012;10:211-7. 12. Kochlef A, Gargouri D, Kilani A, Ouakaa A, Elloumi H, Kharrat J, et al. Retained common bile duct stones after endoscopic sphincterotomy: temporary and longterm treatment with biliary stenting. Tunis Med. 2011;89:342-6. 13. Jain SK, Stein R, Bhuva M, Goldberg MJ. Pigtail stents: an alternative in the treatment of difficult bile duct stones. Gastrointest Endosc. 2000;52:490-3. 14. Maxton DG, Tweedle DE, Martin DF. Retained common bile duct stones after endoscopic sphincterotomy: temporary and longterm treatment with biliary stenting. Gut. 1995;36:446-9. 15. Park DH, Lee SS, Lee TH, Ryu CH, Kim HJ, Seo D-W, et al. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study (with videos). Gastrointest Endosc. 2011;73:64-70. 16. Koksal AS, Eminler AT, Parlak E. Fully Covered Metal Stents Safely Facilitate Extraction of Difficult Bile Duct Stones. Surg Laparosc Endosc Percutan Tech. 2023;33:152-61. 17. Zheng X, Wu J, Sun B, Wu Y-C, Bo Z-Y, Wan W, et al. Clinical outcome of endoscopic covered metal stenting for resolution of benign biliary stricture: Systematic review and meta-analysis. Dig Endosc Off J Jpn Gastroenterol Endosc Soc. 2017;29:198-210. 18. Jang DK, Lee SH, Ahn DW, Paik WH, Lee JM, Lee JK, et al. Correction: Factors associated with complete clearance of difficult common bile duct stones after temporary biliary stenting followed by a second ERCP: a multicenter, retrospective, cohort study. Endoscopy. 2020;52:C4. 19. Jang DK, Lee SH, Ahn DW, Paik WH, Lee JM, Lee JK, et al. Factors associated with complete clearance of difficult common bile duct stones after temporary biliary stenting followed by a second ERCP: a multicenter, retrospective, cohort study. Endoscopy. 2020;52:462-8. 20. Hartery K, Lee CS, Doherty GA, Murray FE, Cullen G, Patchett SE, et al. Covered self-expanding metal stents for the management of common bile duct stones. Gastrointest Endosc. 2017;85:181-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biliary drainage in people with Biliary Stones and Bile Duct Diseases, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06170632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.