Effect of 8.5 F Plastic Stent Without Proximal Flap on Prevention of Post-ERCP Cholangitis

Complication Clinical Trial

Official title:

Effect of 8.5 F Plastic Stent Without Proximal Flap on Prevention of Post-ERCP Cholangitis on Patients With choledocholithiasis--a Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594891
• Other study ID #: 2011-001-004
• Status: Completed
• Phase: N/A
• First received: November 1, 2015
• Last updated: May 21, 2016
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Zhejiang Province
• Study type: Interventional

Clinical Trial Summary

Cholangitis is one of the main complications of endoscopic retrograde cholangiopancreatography (ERCP). Plastic biliary stent was used to prevent the occurrence of post-ERCP cholangitis, but the stent should be taken out 1-2 weeks after ERCP with endoscope again. 8.5 F plastic stent with proximal flap can discharge self-driven from biliary to the gut, it has the advantage of avoiding pulling stent out with endoscope again. The purpose of this study is to explore 8.5 F plastic stent with proximal flap on preventing post-ERCP cholangitis of ERCP in patients with choledocholithiasis.

Description:

Since its introduction in 1968, endoscopic retrograde cholangiopancreatography (ERCP) has become a commonly performed endoscopic procedure, and the first choice in the management of choledocholithiasis. Although as an endoscopic minimally invasive procedure, there are still certain complications of ERCP, cholangitis is one of the main complications. In European and American countries, plastic biliary stent was used to prevent the occurrence of post-ERCP cholangitis, but the stent should be taken out 1-2 weeks after ERCP with endoscope again. In China endoscopic nasobiliary drainage is usually adopted to prevent post-ERCP cholangitis. Although nose bile duct was more convenient to pull out without endoscope again, but patients often feel nose pharynx ministry unwell obviously. 8.5 F plastic stent with proximal flap can discharge self-driven from biliary to the gut, it has the advantage of avoiding pulling stent out with endoscope again. The purpose of this study is to explore 8.5 F plastic stent with proximal flap on preventing post-ERCP cholangitis of ERCP in patients with choledocholithiasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Obtention of a written informed consent; Patient with choledocholithiasis; Common bile duct stones are removed clearlly.

Exclusion Criteria:

No written informed consent; Combined with acute pancreatitis, acute cholangitis pre-ERCP; Patient under 18 or over 75 years.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholangitis
• Complication

Intervention

Device:
• endoscopic retrograde biliary drainage
A 8.5 F plastic stent with proximal flap (XinChang medical instrument co., LTD,Shanghai, China) will be inserted into common bile duct with standard procedure.
• endoscopic nasobiliary drainage
A nose bile duct(XinChang medical instrument co., LTD,Shanghai, China) will be inserted into common bile duct with standard procedure.

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

References & Publications (1)

ASGE Standards of Practice Committee, Anderson MA, Fisher L, Jain R, Evans JA, Appalaneni V, Ben-Menachem T, Cash BD, Decker GA, Early DS, Fanelli RD, Fisher DA, Fukami N, Hwang JH, Ikenberry SO, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Shergill AK, Dominitz JA. Complications of ERCP. Gastrointest Endosc. 2012 Mar;75(3):467-73. doi: 10.1016/j.gie.2011.07.010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ERCP cholangitis	The rate and severity of post-ERCP cholangitis will compared between two groups.	three months	No
Secondary	adverse events	Number of participants with adverse events; type, frequency and intensity of adverse events.	three months	Yes