Bile Duct StrictureNCT03310554
Suspended Overlength Biliary Stents Preventing Duodenobiliary Reflux in Patients With Biliary Stricture
A study testing 26cm suspended overlength biliary stents, 30cm suspended overlength biliary stents and ordinary plastic biliary stents in people with Bile Duct Stricture, run by Peking University Third Hospital at 1 site in China.
Trial summary
Endoscopic insertion of plastic or metal stents in bile duct under endoscopic retrograde cholangiopancreatography is a well established treatment of distal malignant biliary obstruction.Biliary stents are widely used to relieve symptoms of malignant biliary stricture.Now, the mainly used biliary stents include plastic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bile Duct Stricture
- What is being tested?
- 26cm suspended overlength biliary stents, 30cm suspended overlength biliary stents and ordinary plastic biliary stents
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2018to 30 Sep 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unresectable extrahepatic malignant biliary stricture,available for insertion of biliary stents in ERCP to alleviate biliary stricture.
Who cannot join
- Patients agree with metal biliary stents;
- Patients with biliary stricture need double or multiple stents inserted;
- Patients with previous surgical drainage procedure;
- Patients with resectable biliary occlusion;
- A guidewire could not be passed through the stricture;
- Patients with duodenal obstruction and duodenal endoscopy could not be reached to papillary.;
- Patients with any contraindication to endoscopic procedures or refuse informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Yonghui Huang, archiater, 13911765322, xuxiao_1028@126.com
About this study
Official title: Prevention of Duodenobiliary Reflux Via Suspended Overlength Biliary Stents in Patients With Biliary Stricture
Endoscopic insertion of plastic or metal stents in bile duct under endoscopic retrograde cholangiopancreatography is a well established treatment of distal malignant biliary obstruction.Biliary stents are widely used to relieve symptoms of malignant biliary stricture.Now, the mainly used biliary stents include plastic and metal stents. The main limitation of long time plastic stents is stents occlusion. Biliary plastic stents are changed every 2 to 3 months due to an expected median patency from 77 to 126 days.Metal stents present a lower risk of recurring biliary occlusion, yet high cost and stents occlusion are eventually inevitable. The mechanism of biliary stents occlusion include biliary sluge of the accumulation of bacteria and duodenal biliary reflux .The anti-reflux barrier of Oddi's sphincter disappears after the insertion of biliary stents and the presure in bile duct lowers the duodenals, which cause the retrograde flow of duodenal material into the biliary ducts. Besides, ordinary biliary plastic stent is short which can also shortens the length of duodenal biliary reflux . Therefore, trying to prevent the duodenal biliary reflux is very important in reducing biliary stents occlusion and it is gradually concerned by clinical researchers. Some studies have showed that plastic stents with antireflux valves can effectively reduce the biliary stent stricture and prolong the stents patency, which means reducing duodenobiliary reflux is surely useful for keeping biliary stent patency.So,we assume to explore an innovatively suspended overlength biliary stents (made from nasobiliary tube with length of 26cm or 30cm) as substitution for ordinary biliary plastic stent to prevent the duodenobiliary reflux by extending the length of duodenal content reflux and avoid the stents shift via suspending in intrahepatic duct. In this study,we will design a randomized controlled trial to compare the patency of different length of suspended overlength biliary stents and ordinary plastic biliary stents in patients with distal malignant biliary obstruction to evaluate the effect and safety of suspended overlength biliary stents for the prevention of duodenobiliary reflux and the effect of different length of the stents.
Read the detailed description
Endoscopic insertion of plastic or metal stents in bile duct under endoscopic retrograde cholangiopancreatography is a well established treatment of distal malignant biliary obstruction.Biliary stents are widely used to relieve symptoms of malignant biliary stricture.Now, the mainly used biliary stents include plastic and metal stents. The main limitation of long time plastic stents is stents occlusion. Biliary plastic stents are changed every 2 to 3 months due to an expected median patency from 77 to 126 days.Metal stents present a lower risk of recurring biliary occlusion, yet high cost and stents occlusion are eventually inevitable. The mechanism of biliary stents occlusion include biliary sluge of the accumulation of bacteria and duodenal biliary reflux .The anti-reflux barrier of Oddi's sphincter disappears after the insertion of biliary stents and the presure in bile duct lowers the duodenals, which cause the retrograde flow of duodenal material into the biliary ducts. Besides, ordinary biliary plastic stent is short which can also shortens the length of duodenal biliary reflux . Therefore, trying to prevent the duodenal biliary reflux is very important in reducing biliary stents occlusion and it is gradually concerned by clinical researchers. Some studies have showed that plastic stents with antireflux valves can effectively reduce the biliary stent stricture and prolong the stents patency, which means reducing duodenobiliary reflux is surely useful for keeping biliary stent patency .So,we assume to explore an innovatively suspended overlength biliary stents (made from nasobiliary tube with length of 26cm or 30cm) as substitution for ordinary biliary plastic stent to prevent the duodenobiliary reflux by extending the length of duodenal content reflux and avoid the stents shift via suspending in intrahepatic duct. In this study,we will design a randomized controlled trial to compare the patency of different length of suspended overlength biliary stents and ordinary plastic biliary stents in patients with distal malignant biliary obstruction to evaluate the effect and safety of suspended overlength biliary stents for the prevention of duodenobiliary reflux and the effect of different length of the stents.
The investigators will recruit patients according to admission criteria and exclusion criteria. Eligible patients with distal malignant biliary obstruction will be randomly divided into 26cm suspended overlength biliary stents group (experimental group) 、30cm suspended overlength biliary stents group (experimental group) and ordinary plastic biliary stents group (control group).The test groups will be placed the 26cm or 30cm suspended overlength biliary stents in introhepatic bile duct in ERCP. The control group will be placed ordinary plastic biliary stents in ERCP. The primary endpoint is the duration of stent patency and the rate of stent occlusion.The secondary outcomes include the mortality of each group, adverse events and the rate of technical success.
- Conditions
- Bile Duct Stricture
- Being tested
- 26cm suspended overlength biliary stents, 30cm suspended overlength biliary stents, ordinary plastic biliary stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
26cm suspended overlength biliary stentsProcedure or surgery
The test group will be placed 26cm suspended overlength biliary stents in introhepatic bile duct in ERCP
30cm suspended overlength biliary stentsProcedure or surgery
The test group will be placed 30cm suspended overlength biliary stents in introhepatic bile duct in ERCP
ordinary plastic biliary stentsProcedure or surgery
The control group will be placed ordinary plastic biliary stents in bile duct in ERCP
| Study group | Role | What they receive |
|---|---|---|
| 26cm suspended overlength biliary stents group | Experimental | Not described Receives: Procedure: 26cm suspended overlength biliary stents |
| 30cm suspended overlength biliary stents group | Experimental | Not described Receives: Procedure: 30cm suspended overlength biliary stents |
| ordinary plastic biliary stents group | Other | Not described Receives: Procedure: ordinary plastic biliary stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent patency and stent occlusion rate
Patients with symptoms of cholangitis and worsening liver function tests suggestive of cholestasis are considered as premature stent occlusion.
Measured: 12 months after ERCP
Secondary outcomes (3)
mortality of each group
We will compare the mortality of each group after the insertion of biliary stents.
Measured: 12 months after ERCP
adverse events
Adverse events include complications of post ERCP such as pancreatitis,biliary infection, bleeding, perforation and stent migration etc.
Measured: 12 months after ERCP
the rate of technical success
Technical success is defined as successful insertion of the stent into the bile duct during ERCP.
Measured: 12 months after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start11 Jan 2018
- Primary completion10 Mar 2021
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Bile Duct StrictureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Yonghui, Peking University Third Hospital
- Investigators
- Yonghui Huang, archiater, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310554
- Sponsor's protocol ID
- M2017187
- Status last verified
- Aug 2021
- First submitted
- 11 Oct 2017
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dumonceau JM, Tringali A, Blero D, Deviere J, Laugiers R, Heresbach D, Costamagna G; European Society of Gastrointestinal Endoscopy. Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy. 2012 Mar;44(3):277-98. doi: 10.1055/s-0031-1291633. Epub 2012 Feb 1.
PubMed 22297801Libby ED, Leung JW. Prevention of biliary stent clogging: a clinical review. Am J Gastroenterol. 1996 Jul;91(7):1301-8.
PubMed 8677983Pedersen FM, Lassen AT, Schaffalitzky de Muckadell OB. Randomized trial of stent placed above and across the sphincter of Oddi in malignant bile duct obstruction. Gastrointest Endosc. 1998 Dec;48(6):574-9. doi: 10.1016/s0016-5107(98)70038-0.
PubMed 9852446van Berkel AM, Boland C, Redekop WK, Bergman JJ, Groen AK, Tytgat GN, Huibregtse K. A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction. Endoscopy. 1998 Oct;30(8):681-6. doi: 10.1055/s-2007-1001388.
PubMed 9865556van Berkel AM, Bruno MJ, Bergman JJ, van Deventer SJ, Tytgat GN, Huibregtse K. A prospective randomized study of hydrophilic polymer-coated polyurethane versus polyethylene stents in distal malignant biliary obstruction. Endoscopy. 2003 Jun;35(6):478-82. doi: 10.1055/s-2003-39666.
PubMed 12783344Reddy DN, Banerjee R, Choung OW. Antireflux biliary stents: are they the solution to stent occlusions? Curr Gastroenterol Rep. 2006 Apr;8(2):156-60. doi: 10.1007/s11894-006-0012-x.
PubMed 16533479van Berkel AM, van Marle J, van Veen H, Groen AK, Huibregtse K. A scanning electron microscopic study of biliary stent materials. Gastrointest Endosc. 2000 Jan;51(1):19-22. doi: 10.1016/s0016-5107(00)70380-4.
PubMed 10625789Soehendra N, Reynders-Frederix V. Palliative bile duct drainage - a new endoscopic method of introducing a transpapillary drain. Endoscopy. 1980 Jan;12(1):8-11. doi: 10.1055/s-2007-1021702.
PubMed 7353562Wagh MS, de Bellis M, Fogel EL, Frakes JT, Johanson JF, Qaseem T, Howell DA, Lehman GA, Sherman S. Multicenter Randomized Trial of 10-French versus 11.5-French Plastic Stents for Malignant Biliary Obstruction. Diagn Ther Endosc. 2013;2013:891915. doi: 10.1155/2013/891915. Epub 2013 May 2.
PubMed 23737656Groen AK, Out T, Huibregtse K, Delzenne B, Hoek FJ, Tytgat GN. Characterization of the content of occluded biliary endoprostheses. Endoscopy. 1987 Mar;19(2):57-9. doi: 10.1055/s-2007-1018235.
PubMed 3106022Speer AG, Cotton PB, Rode J, Seddon AM, Neal CR, Holton J, Costerton JW. Biliary stent blockage with bacterial biofilm. A light and electron microscopy study. Ann Intern Med. 1988 Apr;108(4):546-53. doi: 10.7326/0003-4819-108-4-546.
PubMed 2450501Leung JW, Ling TK, Kung JL, Vallance-Owen J. The role of bacteria in the blockage of biliary stents. Gastrointest Endosc. 1988 Jan-Feb;34(1):19-22. doi: 10.1016/s0016-5107(88)71223-7.
PubMed 3280393Liu YF, Saccone GT, Thune A, Baker RA, Harvey JR, Toouli J. Sphincter of Oddi regulates flow by acting as a variable resistor to flow. Am J Physiol. 1992 Nov;263(5 Pt 1):G683-9. doi: 10.1152/ajpgi.1992.263.5.G683.
PubMed 1443142Sung JY, Leung JW, Shaffer EA, Lam K, Olson ME, Costerton JW. Ascending infection of the biliary tract after surgical sphincterotomy and biliary stenting. J Gastroenterol Hepatol. 1992 May-Jun;7(3):240-5. doi: 10.1111/j.1440-1746.1992.tb00971.x.
PubMed 1611012Donelli G, Guaglianone E, Di Rosa R, Fiocca F, Basoli A. Plastic biliary stent occlusion: factors involved and possible preventive approaches. Clin Med Res. 2007 Mar;5(1):53-60. doi: 10.3121/cmr.2007.683.
PubMed 17456835
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Duodenobiliary Reflux Via Suspended Overlength Biliary Stents in Patients With Biliary Stricture
- ClinicalTrials.gov ID
- NCT03310554
- Acronym / sponsor ID
- M2017187
- Conditions
- Bile Duct Stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 16 Oct 2017 (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.
Endoscopic insertion of plastic or metal stents in bile duct under endoscopic retrograde cholangiopancreatography is a well established treatment of distal malignant biliary obstruction.Biliary stents are widely used to relieve symptoms of malignant biliary stricture.Now, the mainly used biliary stents include plastic and metal stents. The main limitation of long time plastic stents is stents occlusion. Biliary plastic stents are changed every 2 to 3 months due to an expected median patency from 77 to 126 days.Metal stents present a lower risk of recurring biliary occlusion, yet high cost and stents occlusion are eventually inevitable. The mechanism of biliary stents occlusion include biliary sluge of the accumulation of bacteria and duodenal biliary reflux .The anti-reflux barrier of Oddi's sphincter disappears after the insertion of biliary stents and the presure in bile duct lowers the duodenals, which cause the retrograde flow of duodenal material into the biliary ducts. Besides, ordinary biliary plastic stent is short which can also shortens the length of duodenal biliary reflux . Therefore, trying to prevent the duodenal biliary reflux is very important in reducing biliary stents occlusion and it is gradually concerned by clinical researchers. Some studies have showed that plastic stents with antireflux valves can effectively reduce the biliary stent stricture and prolong the stents patency, which means reducing duodenobiliary reflux is surely useful for keeping biliary stent patency.So,we assume to explore an innovatively suspended overlength biliary stents (made from nasobiliary tube with length of 26cm or 30cm) as substitution for ordinary biliary plastic stent to prevent the duodenobiliary reflux by extending the length of duodenal content reflux and avoid the stents shift via suspending in intrahepatic duct. In this study,we will design a randomized controlled trial to compare the patency of different length of suspended overlength biliary stents and ordinary plastic biliary stents in patients with distal malignant biliary obstruction to evaluate the effect and safety of suspended overlength biliary stents for the prevention of duodenobiliary reflux and the effect of different length of the stents.
Detailed description
Endoscopic insertion of plastic or metal stents in bile duct under endoscopic retrograde cholangiopancreatography is a well established treatment of distal malignant biliary obstruction.Biliary stents are widely used to relieve symptoms of malignant biliary stricture.Now, the mainly used biliary stents include plastic and metal stents. The main limitation of long time plastic stents is stents occlusion. Biliary plastic stents are changed every 2 to 3 months due to an expected median patency from 77 to 126 days.Metal stents present a lower risk of recurring biliary occlusion, yet high cost and stents occlusion are eventually inevitable. The mechanism of biliary stents occlusion include biliary sluge of the accumulation of bacteria and duodenal biliary reflux .The anti-reflux barrier of Oddi's sphincter disappears after the insertion of biliary stents and the presure in bile duct lowers the duodenals, which cause the retrograde flow of duodenal material into the biliary ducts. Besides, ordinary biliary plastic stent is short which can also shortens the length of duodenal biliary reflux . Therefore, trying to prevent the duodenal biliary reflux is very important in reducing biliary stents occlusion and it is gradually concerned by clinical researchers. Some studies have showed that plastic stents with antireflux valves can effectively reduce the biliary stent stricture and prolong the stents patency, which means reducing duodenobiliary reflux is surely useful for keeping biliary stent patency .So,we assume to explore an innovatively suspended overlength biliary stents (made from nasobiliary tube with length of 26cm or 30cm) as substitution for ordinary biliary plastic stent to prevent the duodenobiliary reflux by extending the length of duodenal content reflux and avoid the stents shift via suspending in intrahepatic duct. In this study,we will design a randomized controlled trial to compare the patency of different length of suspended overlength biliary stents and ordinary plastic biliary stents in patients with distal malignant biliary obstruction to evaluate the effect and safety of suspended overlength biliary stents for the prevention of duodenobiliary reflux and the effect of different length of the stents.
The investigators will recruit patients according to admission criteria and exclusion criteria. Eligible patients with distal malignant biliary obstruction will be randomly divided into 26cm suspended overlength biliary stents group (experimental group) 、30cm suspended overlength biliary stents group (experimental group) and ordinary plastic biliary stents group (control group).The test groups will be placed the 26cm or 30cm suspended overlength biliary stents in introhepatic bile duct in ERCP. The control group will be placed ordinary plastic biliary stents in ERCP. The primary endpoint is the duration of stent patency and the rate of stent occlusion.The secondary outcomes include the mortality of each group, adverse events and the rate of technical success.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 26cm suspended overlength biliary stents group | Experimental | Procedure: 26cm suspended overlength biliary stents |
| 30cm suspended overlength biliary stents group | Experimental | Procedure: 30cm suspended overlength biliary stents |
| ordinary plastic biliary stents group | Other | Procedure: ordinary plastic biliary stents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Unresectable extrahepatic malignant biliary stricture,available for insertion of biliary stents in ERCP to alleviate biliary stricture.
Key exclusion criteria (7 listed)
- Patients agree with metal biliary stents;
- Patients with biliary stricture need double or multiple stents inserted;
- Patients with previous surgical drainage procedure;
- Patients with resectable biliary occlusion;
- A guidewire could not be passed through the stricture;
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 |
|---|---|---|
| 26cm suspended overlength biliary stentsThe test group will be placed 26cm suspended overlength biliary stents in introhepatic bile duct in ERCP | Procedure or surgery | 26cm suspended overlength biliary stents group |
| 30cm suspended overlength biliary stentsThe test group will be placed 30cm suspended overlength biliary stents in introhepatic bile duct in ERCP | Procedure or surgery | 30cm suspended overlength biliary stents group |
| ordinary plastic biliary stentsThe control group will be placed ordinary plastic biliary stents in bile duct in ERCP | Procedure or surgery | ordinary plastic biliary stents group |
Primary outcome
stent patency and stent occlusion rate
Time frame: 12 months after ERCP
Patients with symptoms of cholangitis and worsening liver function tests suggestive of cholestasis are considered as premature stent occlusion.
3 secondary outcomes
mortality of each group
Time frame: 12 months after ERCP
adverse events
Time frame: 12 months after ERCP
the rate of technical success
Time frame: 12 months after ERCP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Results publication: PubMed 22297801Dumonceau JM, Tringali A, Blero D, Deviere J, Laugiers R, Heresbach D, Costamagna G; European Society of Gastrointestinal Endoscopy. Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy. 2012 Mar;44(3):277-98. doi: 10.1055/s-0031-1291633. Epub 2012 Feb 1.
- Results publication: PubMed 8677983Libby ED, Leung JW. Prevention of biliary stent clogging: a clinical review. Am J Gastroenterol. 1996 Jul;91(7):1301-8.
- Results publication: PubMed 9852446Pedersen FM, Lassen AT, Schaffalitzky de Muckadell OB. Randomized trial of stent placed above and across the sphincter of Oddi in malignant bile duct obstruction. Gastrointest Endosc. 1998 Dec;48(6):574-9. doi: 10.1016/s0016-5107(98)70038-0.
- Results publication: PubMed 9865556van Berkel AM, Boland C, Redekop WK, Bergman JJ, Groen AK, Tytgat GN, Huibregtse K. A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction. Endoscopy. 1998 Oct;30(8):681-6. doi: 10.1055/s-2007-1001388.
- Results publication: PubMed 12783344van Berkel AM, Bruno MJ, Bergman JJ, van Deventer SJ, Tytgat GN, Huibregtse K. A prospective randomized study of hydrophilic polymer-coated polyurethane versus polyethylene stents in distal malignant biliary obstruction. Endoscopy. 2003 Jun;35(6):478-82. doi: 10.1055/s-2003-39666.
- Results publication: PubMed 16533479Reddy DN, Banerjee R, Choung OW. Antireflux biliary stents: are they the solution to stent occlusions? Curr Gastroenterol Rep. 2006 Apr;8(2):156-60. doi: 10.1007/s11894-006-0012-x.
- Results publication: PubMed 10625789van Berkel AM, van Marle J, van Veen H, Groen AK, Huibregtse K. A scanning electron microscopic study of biliary stent materials. Gastrointest Endosc. 2000 Jan;51(1):19-22. doi: 10.1016/s0016-5107(00)70380-4.
- Results publication: PubMed 7353562Soehendra N, Reynders-Frederix V. Palliative bile duct drainage - a new endoscopic method of introducing a transpapillary drain. Endoscopy. 1980 Jan;12(1):8-11. doi: 10.1055/s-2007-1021702.
- Results publication: PubMed 23737656Wagh MS, de Bellis M, Fogel EL, Frakes JT, Johanson JF, Qaseem T, Howell DA, Lehman GA, Sherman S. Multicenter Randomized Trial of 10-French versus 11.5-French Plastic Stents for Malignant Biliary Obstruction. Diagn Ther Endosc. 2013;2013:891915. doi: 10.1155/2013/891915. Epub 2013 May 2.
- Results publication: PubMed 3106022Groen AK, Out T, Huibregtse K, Delzenne B, Hoek FJ, Tytgat GN. Characterization of the content of occluded biliary endoprostheses. Endoscopy. 1987 Mar;19(2):57-9. doi: 10.1055/s-2007-1018235.
- Results publication: PubMed 2450501Speer AG, Cotton PB, Rode J, Seddon AM, Neal CR, Holton J, Costerton JW. Biliary stent blockage with bacterial biofilm. A light and electron microscopy study. Ann Intern Med. 1988 Apr;108(4):546-53. doi: 10.7326/0003-4819-108-4-546.
- Results publication: PubMed 3280393Leung JW, Ling TK, Kung JL, Vallance-Owen J. The role of bacteria in the blockage of biliary stents. Gastrointest Endosc. 1988 Jan-Feb;34(1):19-22. doi: 10.1016/s0016-5107(88)71223-7.
- 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.
Yonghui Huang, archiater principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 26cm suspended overlength biliary stents, 30cm suspended overlength biliary stents and ordinary plastic biliary stents in people with Bile Duct Stricture, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 7 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 11 Aug 2021. 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 China. 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?
Contact Yonghui Huang, archiater (13911765322, xuxiao_1028@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stent patency and stent occlusion rate (time frame: 12 months after ERCP). 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 NCT03310554, which also lists 21 linked publications.
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 11 Aug 2021.