Intraintestinal Extended Biliary Stents Preventing Duodenobiliary Reflux in Patients With Biliary Stricture

NCT04550819 | Unknown DMC

• 1 other identifier: X20200703
• Study Type: interventional
• Target: 724
• Locations: 1 country
• Sites: 1

Brief Summary

Metal or plastic biliary stents placement under Endoscopic Retrograde Cholangiopancreatography(ERCP) is a well-established treatment for patients with benign biliary obstruction to relieve jaundice, a palliative treatment for patients with unresectable malignant pancreaticobiliary obstruction and a bridge to surgery for patients with resectable disease. 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 sludge 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 pressure in bile duct lowers the duodenale, 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 intraintestinal extended biliary stents (reformed with nasobiliary tube ) 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 multicenter stratified randomized controlled trial to compare the patency of intraintestinal extended biliary stents and ordinary plastic biliary stents in patients with malignant or benign biliary obstruction respectively and evaluate the effect of intraintestinal extended biliary stents for the prevention of duodenobiliary reflux.

Conditions

Bile Duct Stricture

Outcome Measures

Primary Outcomes (1)

• the duration of 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 Outcomes (3)

• mortality of each group

  12 months after ERCP

• adverse events

  12 months after ERCP

• the rate of technical success

  12 months after ERCP

Study Arms (4)

IEBSs in malignant extrahepatic biliary stricture

EXPERIMENTAL

Intraintestinal extended biliary stents(IEBSs) in patients with malignant extrahepatic biliary stricture

Procedure: intraintestinal extended biliary stents

CPBSs in malignant extrahepatic biliary stricture

ACTIVE COMPARATOR

Conventional plastic biliary stents(CPBSs) in patients with malignant extrahepatic biliary stricture

Procedure: ordinary plastic biliary stents

IEBSs in benign extrahepatic biliary stricture

EXPERIMENTAL

Intraintestinal extended biliary stents(IEBSs) in patients with benign extrahepatic biliary stricture

Procedure: intraintestinal extended biliary stents

CPBSs in benign extrahepatic biliary stricture

ACTIVE COMPARATOR

Conventional plastic biliary stents(CPBSs) in patients with benign extrahepatic biliary stricture

Procedure: ordinary plastic biliary stents

Interventions

intraintestinal extended biliary stents PROCEDURE

The test group will be placed intraintestinal extended biliary stents in intrahepatic bile duct in ERCP

IEBSs in benign extrahepatic biliary stricture; IEBSs in malignant extrahepatic biliary stricture

ordinary plastic biliary stents PROCEDURE

The test group will be placed ordinary plastic biliary stents in intrahepatic bile duct in ERCP

CPBSs in benign extrahepatic biliary stricture; CPBSs in malignant extrahepatic biliary stricture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Malignant or benign extrahepatic biliary stricture,available for insertion of biliary stents in ERCP to alleviate biliary stricture

You may not qualify if:

• Patients with malignant or benign biliary stricture do not agree with endoscopic treatment
• Patients agree with metal biliary stents
• Patients with resectable biliary occlusion
• A guidewire could not be passed through the stricture
• Patients with an expected life survival \<3months
• Patients with duodenal obstruction and duodenal endoscopy could not be reached to papillary

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (14)

• 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.

  PMID: 22297801 BACKGROUND

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

  PMID: 8677983 BACKGROUND

• 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. doi: 10.1055/s-2007-1001388.

  PMID: 9865556 BACKGROUND

• 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. doi: 10.1055/s-2003-39666.

  PMID: 12783344 BACKGROUND

• 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. doi: 10.1007/s11894-006-0012-x.

  PMID: 16533479 BACKGROUND

• 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. doi: 10.1016/s0016-5107(00)70380-4.

  PMID: 10625789 BACKGROUND

• 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. doi: 10.1055/s-2007-1018235.

  PMID: 3106022 BACKGROUND

• 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. doi: 10.7326/0003-4819-108-4-546.

  PMID: 2450501 BACKGROUND

• 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. doi: 10.1152/ajpgi.1992.263.5.G683.

  PMID: 1443142 BACKGROUND

• 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. doi: 10.3121/cmr.2007.683.

  PMID: 17456835 BACKGROUND

• 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. doi: 10.1055/s-2005-870131.

  PMID: 16032491 BACKGROUND

• 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 Endosc. 2007 May;65(6):819-28. doi: 10.1016/j.gie.2006.09.011. Epub 2007 Mar 26.

  PMID: 17383650 BACKGROUND

• Vihervaara H, Gronroos 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. Epub 2016 Oct 18.

  PMID: 27754790 BACKGROUND

• 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. doi: 10.1038/srep21714.

  PMID: 26883081 BACKGROUND

Study Officials

• Yonghui Huang, archiater

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonghui Huang, archiater

CONTACT

13911765322; xuxiao_1028@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)