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

Zhejiang University

Status: Completed

Conditions: Complication; Cholangitis

Treatments: Device: endoscopic nasobiliary drainage; Device: endoscopic retrograde biliary drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT02594891

2011-001-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups, including a placebo group

endoscopic retrograde biliary drainage

Experimental group

Description:

Patients will undergo endoscopic retrograde biliary drainage (ERBD) with 8.5 F plastic stent with proximal flap when bile duct stones were removed clearly with ERCP. The stent will be taken out with endoscopy three months later if not discharge self-driven.

Treatment:

Device: endoscopic retrograde biliary drainage

endoscopic nasobiliary drainage

Placebo Comparator group

Description:

Patients will undergo endoscopic nasobiliary drainage (ENBD) when bile duct stones were removed clearly with ERCP. The nose bile duct will be pulled out 3-5 days later if no cholangitis occurrence.

Treatment:

Device: endoscopic nasobiliary drainage