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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02594891

Enrollment

Registered

2015-11-03

Start date

2015-11-30

Completion date

2016-02-29

Last updated

2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangitis, Complication

Keywords

cholangitis, endoscopic retrograde cholangiopancreatography, complication

Brief 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.

Detailed 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.

Interventions

DEVICEendoscopic 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.

DEVICEendoscopic nasobiliary drainage

A nose bile duct（XinChang medical instrument co., LTD,Shanghai, China) will be inserted into common bile duct with standard procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Post-ERCP cholangitis	three months	The rate and severity of post-ERCP cholangitis will compared between two groups.

Secondary

Measure	Time frame	Description
adverse events	three months	Number of participants with adverse events; type, frequency and intensity of adverse events.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026