Suspended Overlength Biliary Stents Preventing Duodenobiliary Reflux in Patients With Biliary Stricture

Bile Duct Stricture Clinical Trial

Official title:

Prevention of Duodenobiliary Reflux Via Suspended Overlength Biliary Stents in Patients With Biliary Stricture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03310554
• Other study ID #: M2017187
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2021
• Source: Peking University Third Hospital
• Contact: Yonghui Huang, archiater
• Phone: 13911765322
• Email: xuxiao_1028[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: September 30, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Unresectable extrahepatic malignant biliary stricture,available for insertion of biliary stents in ERCP to alleviate biliary stricture.

Exclusion Criteria:

1. Patients agree with metal biliary stents;

2. Patients with biliary stricture need double or multiple stents inserted;

3. Patients with previous surgical drainage procedure;

4. Patients with resectable biliary occlusion;

5. A guidewire could not be passed through the stricture;

6. Patients with duodenal obstruction and duodenal endoscopy could not be reached to papillary.;

7. Patients with any contraindication to endoscopic procedures or refuse informed consent

Related Conditions & MeSH terms

• Bile Duct Stricture
• Constriction, Pathologic

Intervention

Procedure:
• 26cm suspended overlength biliary stents
The test group will be placed 26cm suspended overlength biliary stents in introhepatic bile duct in ERCP
• 30cm suspended overlength biliary stents
The test group will be placed 30cm suspended overlength biliary stents in introhepatic bile duct in ERCP
• ordinary plastic biliary stents
The control group will be placed ordinary plastic biliary stents in bile duct in ERCP

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (21)

Donelli 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. Review. — View Citation

Dua KS, Reddy ND, Rao VG, Banerjee R, Medda B, Lang I. Impact of reducing duodenobiliary reflux on biliary stent patency: an in vitro evaluation and a prospective randomized clinical trial that used a biliary stent with an antireflux valve. Gastrointest E — View Citation

Dumonceau JM, Tringali A, Blero D, Devière 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) clinica — View Citation

Groen 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. — View Citation

Kenawy el-R, Abdel-Hay FI, el-Raheem A, el-Shanshoury R, el-Newehy MH. Biologically active polymers: synthesis and antimicrobial activity of modified glycidyl methacrylate polymers having a quaternary ammonium and phosphonium groups. J Control Release. 19 — View Citation

Leung 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. — View Citation

Libby ED, Leung JW. Prevention of biliary stent clogging: a clinical review. Am J Gastroenterol. 1996 Jul;91(7):1301-8. Review. — View Citation

Liu 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. — View Citation

Pedersen 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. — View Citation

Reddy DN, Banerjee R, Choung OW. Antireflux biliary stents: are they the solution to stent occlusions? Curr Gastroenterol Rep. 2006 Apr;8(2):156-60. Review. — View Citation

Rees EN, Tebbs SE, Elliott TS. Role of antimicrobial-impregnated polymer and Teflon in the prevention of biliary stent blockage. J Hosp Infect. 1998 Aug;39(4):323-9. — View Citation

Soehendra N, Reynders-Frederix V. Palliative bile duct drainage - a new endoscopic method of introducing a transpapillary drain. Endoscopy. 1980 Jan;12(1):8-11. — View Citation

Speer 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. — View Citation

Sung 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. — View Citation

van 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. — View Citation

van 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. — View Citation

van Berkel AM, van Marle J, Groen AK, Bruno MJ. Mechanisms of biliary stent clogging: confocal laser scanning and scanning electron microscopy. Endoscopy. 2005 Aug;37(8):729-34. — View Citation

van 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. — View Citation

Vihervaara H, Grönroos JM, Hurme S, Gullichsen R, Salminen P. Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study. J Laparoendosc Adv Surg Tech A. 2017 Jan;27(1):53-57. doi: 10.1089/lap.2016.0178. — View Citation

Wagh 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. — View Citation

Yang F, Ren Z, Chai Q, Cui G, Jiang L, Chen H, Feng Z, Chen X, Ji J, Zhou L, Wang W, Zheng S. A novel biliary stent coated with silver nanoparticles prolongs the unobstructed period and survival via anti-bacterial activity. Sci Rep. 2016 Feb 17;6:21714. d — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months after ERCP
Secondary	mortality of each group	We will compare the mortality of each group after the insertion of biliary stents.	12 months after ERCP
Secondary	adverse events	Adverse events include complications of post ERCP such as pancreatitis,biliary infection, bleeding, perforation and stent migration etc.	12 months after ERCP
Secondary	the rate of technical success	Technical success is defined as successful insertion of the stent into the bile duct during ERCP.	12 months after ERCP